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Where to Focus Your Medical Device Complaint Handling Training

%name Where to Focus Your Medical Device Complaint Handling Training

Medical Device Academy performed a data analysis of FDA 483s for 2013, and identified 4 areas of focus for your medical device complaint handling training. 

One of the challenges of creating a strong training curriculum is the need for practical examples. This is why there are lots of stories about real-life companies and products in every Medical Device Academy training event. We learn more from our painful mistakes than we do from our success stories. When you recall product, report deaths involving a product your company made, or if you receive a Warning Letter—these are events that we will never forget.

Medical Device Academy recently posted a blog (http://bit.ly/outsourcing-complaints) about complaint handling, because this is one of the most common areas identified in FDA Form 483s and Warning Letters. Therefore, if you are trying to develop training on the topic of complaint handling (i.e., 21 CFR 820.198), then you should look for examples from your competitor’s mistakes. The following is a list of places you should look:

  1. Past inspection reports issued to your company by the FDA
  2. Any inspection reports or Warning Letters about your competitors that become public
  3. Other Warning Letters that mention complaint handling as an issue

Here’s an example of the type of 483 observation you might find: “Failure to adequately establish and maintain procedures for receiving, reviewing, and evaluating complaints by a formally designated unit, as required by 21 CFR 820.198(a).”

The example above identifies five different problems with a complaint process:

  1. You need a procedure 
  2. You need to designate a complaint handling unit
  3. You need to define the process for receiving complaints
  4. You need to define the process for reviewing complaints
  5. You need to define the process for evaluating complaints

21 CFR 820.198 is a prescriptive requirement in the regulations. Therefore, you not only need to create a procedure specifically for complaint handling, but you also need to ensure each element of the requirement is satisfied. This is important, because FDA inspectors will verify that your procedure includes each element.

Medical Device Academy performed a data analysis of FDA inspection reports for FY2013 (http://bit.ly/Form483-FY2013) in order to identify other common mistakes related to complaint handling. The data analysis of FDA inspection reports for FY2013 identified that there are actually 15 individual citations related to complaint handling that the FDA identified using the TURBO EIR System (http://bit.ly/FDA483s). The table below summarizes the frequencies of these 15 sub-sections that were referenced in citations during FY2013 under the complaint handling category: 

483 Where to Focus Your Medical Device Complaint Handling Training

Medical Device Complaint Handling Training: 4 Critical Areas of Focus

The above table identifies several other sub-sections that present problems for companies. Based upon the data analysis, your company should also be training your complaint handling unit in the following four critical areas:

  1. Maintaining complaint files
  2. Reviewing and evaluating complaints for the need to perform an investigation
  3. Documenting complaint investigations in your complaint files
  4. Determining whether a complaint is reportable under 21 CFR 803

The fourth area is one of the most important, because these complaints involve injury, death and product malfunction. Therefore, you might consider reviewing the TPLC database (http://bit.ly/FDATPLC) for MDRs. The best data to review is data for the same product codes that your company distributes, but reviewing any MDRs can teach your employees which types of incidents need to be reported. This area will also receive increased scrutiny with the recent changes to 21 CFR Part 803 (http://bit.ly/udpated-21CFR803).

Posted in: Complaint Handling

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A Gap Analysis Tool for Updating Your Medical Device Reporting Procedure

new 803 A Gap Analysis Tool for Updating Your Medical Device Reporting Procedure This blog shows you where to find the new FDA regulation for medical device reporting (http://bit.ly/udpated-21CFR803) and the associated guidance document (http://bit.ly/Part803-Guidance). There is also an explanation of how to perform a gap analysis to compare your procedure for medical device reporting against the new 21 CFR 803 (http://bit.ly/Old-21CFR803).

On January 22, 2014, Medical Device Academy posted a blog about how to create your own FDA medical device regulatory updates: http://bit.ly/4Ways-to-Follow-CDRH. That post identified a number of sources on the FDA website where you can locate information about new and revised FDA regulatory requirements. One suggestion was to register for receiving the RSS feeds from the following page: http://bit.ly/CDRH-news-updates. This page is where the FDA’s Center for Devices and Radiological Health (CDRH – http://bit.ly/FDA-CDRH) posts news and updates.

If you registered for the RSS feed from CDRH, then you received an update on February 13, 2014 announcing the new Part 803 regulation for medical device reporting. This is NOT a cause for alarm. The fundamental change is simple:

Medical device manufacturers will no longer be allowed to submit FDA Form 3500A in paper form. It will need to be submitted electronically through the Electronic Submissions Gateway (ESG) (http://bit.ly/ESG-FDA).

ESG Sign-up

This is just another small step for the FDA to move toward digital records, and to integrate with electronic medical records from healthcare providers. The FDA even created a presentation explaining the process for electronic Medical Device Reporting (eMDR). This 8 minute and 45 second presentation is available on the CDRH Learning page: http://bit.ly/CDRH-Learn. Slide 5 of the FDA’s presentation identifies the six steps for obtaining an account for an ESG:

  1. Get a test account with the ESG
  2. Send a letter to authenticate your digital identity (http://bit.ly/Non-repudiation-Letter)
  3. Get a digital certificate
  4. Contact CDRH (eMDR@fda.hhs.gov)
  5. Test sending an MDR to CDRH
  6. CDRH approves production account with the ESG

I have been recommending that my clients switch from submission of the paper FDA Form 3500A to eMDR since 2010, when this training became available. Now, you have 18 months to switch over to eMDR before the August 14, 2015 deadline for implementation. Alternatively, you can also outsource your eMDR reporting to a  service provider that already has an ESG (http://bit.ly/outsourcing-complaints).

Comparison of Current & New Regulations

The first step in understanding the specific changes to the regulation is to compare the old and new versions. The new Part 803 regulation for MDR was released as a PDF document, and therefore it does not lend itself to a direct comparison with the previous version of the regulation. Therefore, Medical Device Academy downloaded the new regulation (http://bit.ly/udpated-21CFR803), and copied and pasted each section into a Word document. We also did this for the current version (http://bit.ly/Old-21CFR803). Then, we compared the two Word documents electronically. Finally, we wrote a gap analysis to summarize the differences between the two documents. If you would like to download this gap analysis, please visit the following webpage: http://bit.ly/21_cfr_803_gapanalysis.

Gap Analysis of Your Medical Device Reporting Procedure

After you download the gap analysis tool that Medical Device Academy created, then you need to perform your own gap analysis of your current MDR procedure against the changes in Part 803. You should create a table with one column identifying the section of the regulations, a second column identifying the section(s) of your current MDR procedure that meet the requirements, and a third column to identify changes that need to be made. You might consider adding additional columns for delegating the responsibility of revising various sections of your procedure, and implementing other tasks listed below (e.g., obtaining an account for ESG).

Next Steps

  1. Download the gap analysis of the new and old versions of 21 CFR 803
  2. Review and update your own MDR procedure to address the changes to 21 CFR 803 which are identified in the gap analysis
  3. Apply for an ESG WebTrader account for Low Volume/Single Reports
  4. Revise your training requirements for anyone responsible for MDRs:
    1. Complete all four applicable CDRH online trainings (http://bit.ly/CDRH-Learn)
    2. Pass a quiz demonstrating training effectiveness (http://bit.ly/TrainingExams)
    3. Review the draft procedure for potential errors or sections that are unclear
    4. Make any final revisions to the procedure based upon feedback from trainees
    5. Implement your revised procedure

If you need help completing the above steps, please contact Medical Device Academy by emailing Rob Packard, or by visiting the webpage for Medical Device Academy’s Complaint Handling and Vigilance group (http://bit.ly/chvg_mda).

Posted in: Complaint Handling

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Medical Device Management Review Procedure Improvements

management review Medical Device Management Review Procedure ImprovementsThe author provides suggestions for improving the writing of your medical device management review, scheduling meetings and engaging top management. 

If the US FDA is not allowed to see Management Review meeting minutes, why were there one-hundred and seven 483 inspection observations against the Management Review process in FY 2012?

The US FDA is also not allowed to view records for internal audits and supplier audits, but there are 483 observations for these processes too. The FDA will assess effectiveness of these processes by reviewing your procedures, by verifying that you have a schedule and you’re sticking to it, and the ultimate test is to look for CAPAs initiated from these processes.

To avoid a 483 inspection observation against your Management Review process, you need four things:

  1. Procedure for Management Reviews
  2. Schedule for your Management Reviews
  3. Template to prevent errors
  4. Top management team that is trained

Writing a Medical Device Management Review Procedure

There is no requirement for a Management Review procedure in ISO 13485, but 21 CFR 820.20c states that the quality system shall be reviewed “at defined intervals and with sufficient frequency according to established procedure.” This frequency may be documented in the Quality Manual, or in a Management Review procedure.

If you choose to write a procedure, keep it simple and reference a controlled template that includes each of the requirements listed above. Your procedure should also allow flexibility for each of the following probable events:

  1. Management Review requires rescheduling
  2. Some of the Management Team is unable to attend
  3. Some of the Management Team can only attend by conference call
  4. An action item from a previous review is left incomplete
  5. An action item is changed after the Management Review
  6. There is insufficient time available to review all the inputs during a single Review

Your Schedule for a Medical Device Management Review

The most common procedural requirements for the frequency of Management Reviews are:

  1. At least once per year
  2. Semi-annually
  3. Quarterly

Most companies choose to require a schedule of “at least once per year,” but what’s the point of reviewing quality system data from last February in January?

13485 Plus” is a guidance document for the implementation of ISO 13485. Section 5.6.1 of the guidance document states, “If changes are planned or being implemented, more frequent reviews are normally needed.” Some companies even include this statement in their Management Review procedure. Unfortunately, most companies do not remember to change their schedule when they plan significant changes to their quality management system—such as mergers, new product launches or an employee lay-off.

Every Management Review should include an action item scheduling the next Management Review. The timing of the next Management Review should reflect changes planned for the quality system and improvements needed to maintain effectiveness.

Conducting more than one Management Review also gives you the flexibility, assuming your procedure allows it, to review only some of the required inputs during a single Management Review. If you are short of time during your next management review, you could intentionally skip a required element. However, this approach also requires that you track which elements have been covered during your annual schedule and which elements were not. Any skipped elements must be covered at least once during the annual schedule for Management Reviews.

A Template for Medical Device Management Review

One of the most common nonconformities during an ISO audit is a finding that one of the required inputs or outputs was not included in the Management Review. The best way to ensure you don’t forget something is to use a template that is maintained by your document control process. This template should include the following:

  1. Eight Inputs (ISO 13485, Clause 5.6.2)
  2. Three Outputs (ISO 13485, Clause 5.6.3)
  3. Review of the Quality Policy (ISO 13485, Clause 5.3)
  4. Review of the Quality Objectives (ISO 13485, Clause 5.4.1)
  5. Review of the QMS effectiveness (ISO 13485, Clause 5.6.1)

The last item should be a conclusion in your management review meeting minutes. Often, the conclusions is worded in the following way, “The Quality Management System remains suitable, adequate and effective—with the exception of the areas that have been identified as requiring corrective actions in this management review.”

Engaging Top Management

Roles and responsibilities for the Management Review must be assigned. Some leaders choose to assign 100% of the Management Review to the Management Representative, and then the same executives complain that reviews are boring and take too long. In order to get the management team engaged, the responsibility for preparing reviews must be assigned to all members of the team. The Management Representative is responsible for “reporting to top management on the performance of the quality management system and any need for improvement,” but the ISO Standard does not imply that the representative cannot seek help from the rest of the team.

Each member of top management should be assigned responsibility for preparing and reporting on part of the Management Review. This approach will ensure that all members of the management team are involved and engaged in the process. Your team may be assigned to work in pairs or smaller teams. Your team’s responsibilities may also be rotated to ensure that each member of the team is cross-trained and understands the importance of each Management Review requirement.

Before you can expect your management team to accept responsibility for preparing and reporting on the performance of the quality management system and improvement needs, Top Management needs training to understand each of the requirements.

Free Webinar Training

Medical Device Academy also offers free webinar training on the Management Review process. If you are interested in training your top management team, please register for this management review webinar. It will also be available as a free recording for anyone that is registered. Registrants will also receive a copy of the webinar slide deck and a copy of Medical Device Academy’s Management Review template.

 

Posted in: ISO Certification

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6 Points for Effective Training on Medical Device QMS Procedures

%name 6 Points for Effective Training on Medical Device QMS ProceduresThe author provides 6 points for conducting effective training on medical device QMS procedures, including questions to ask for building consistent procedures.

Your Quality Management System (QMS) needs to provide objective evidence (i.e., records) that your staff are trained on procedures they use, and that their training was effective. You must also establish documented requirements for competency. The following examples might help:

  1. A record of you attending a course is a training record.
  2. A record of you taking and passing an exam related to that course is a record of training effectiveness.
  3. A record of you performing a procedure, witnessed by the trainer, is a record of competency. Your resume can also be a record of competency.

Unless a change is trivial in nature, signing a piece of paper that states you read and understood a procedure does not demonstrate training effectiveness. Learning and training are active processes that require engagement and interaction.

In a previous blog (http://bit.ly/12PartSOPTemplate), I described a slightly different procedure structure with some extra sections. There are a number of benefits to that structure, one of which is that the structure facilitates training. The extra sections are referred to in this blog. Whatever template you use, consistency of structure and presentation across your procedures makes the procedures easier to learn, and increases usability.

6 Points to Consider for Effective Training on Medical Device QMS Procedures

  1. Training requirements. For a new procedure, decide early in your writing which roles require training, what content is needed and to what level is competency necessary. The example below is table from a Quality Auditing procedure. The table shows different requirements for different roles. I prefer to put this information in the procedure document—where it is unlikely to be overlooked or forgotten.training procedure 6 Points for Effective Training on Medical Device QMS Procedures
  2. Open book? For each of the roles listed above, determine whether you need trainees to be able to follow the procedure without the document at hand, or to know the procedure, and be able to find what they need.
  3. Training method. One-on-one or group? Classroom style, on-job or remote? This depends on your company, nature of the procedure, and on your requirements above.
  4. PowerPoint or not? My preference is to walk trainees through the procedure, actually have them flipping the pages and writing notes on it. If I use PowerPoint, it’s to clarify structure and emphasize important points.
  5. Control of training copies. Paper copies of procedures and forms used for training should be controlled. Your Document Control procedure should allow for clearly marked “Training” copies to be available before the effective date. Make sure your training also reminds trainees where to find the official released copy of procedures after training is completed.
  6. Control of training material. Include your slides, training scenarios, quizzes, etc. in your document control system. Review and revise them each time you change a procedure. 

Building Consistent Procedures: Questions to Ask and Recommendations

Use a consistent structure for your procedures, then build a consistent training structure around that. The predictability in structure will improve the effectiveness of your training.

  1. Purpose. Why are we doing this? What is the outcome we are after?
  2. Scope. When do I use this procedure? When do I not, and what do I do as an alternative?
  3. References. How does this interface to other procedures? Turtle diagrams or interface maps are useful here
  4. Definitions. Unfamiliar jargon, and terms that are used in a very specific way in this procedure
  5. Risk. What risks does this procedure address? How does this affect the design of the procedure – why are we doing it that way? Refer to my earlier blog (http://bit.ly/12PartSOPTemplate) where I explain how to include this in each procedure
  6. The procedure. Walk through the flowchart, explain the accompanying notes, relate the procedure flow to the responsibilities and authorities outlined earlier in the procedure
  7. Records. What do I do with the completed records from this procedure? Where do I find a copy when I need it?
  8. Examples. I suggest a training version of the form (which should be available later for reference) with guidance and examples
  9. Practice. Provide a scenario and a blank form for trainees to work through, individually or in groups
  10. Testing. Check that the training has been effective. The role competencies that were defined earlier are the basis for the effectiveness criteria for a procedure. This training module may be enough to achieve that level, or a broader training programme may be required to ensure operational level competence. See Rob Packard’s blog on training exams for more advice on testing (http://bit.ly/TrainingExams)

Posted in: ISO Certification

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What are the Essential Requirements for Medical Device CE Marking?

ER Table1 What are the Essential Requirements for Medical Device CE Marking?

The author reviews the essential requirements for medical device CE marking. Common mistakes to avoid, and the proposed EU regulations are also discussed.

Essential Requirements (ERs) are the requirements for safety and performance specified in Annex I of the three medical device directives. ERs are divided into Part I (i.e., – general requirements) and Part II (i.e., – requirements for design and construction). Evidence of conformity must be provided for all general requirements in Part 1 for all devices—regardless of risk classification, design or construction. The Design and construction requirements in Part 2 may be not applicable, depending upon your device.

When a Notified Body reviews your Technical File or Design Dossier for CE Marking, the auditor must verify that you have addressed each ER. This is typically demonstrated by providing an ER Checklist (ERC). You can find a template for an ERC on the International Medical Device Regulators Forum (IMDRF) website (http://bit.ly/IMDRFDoc) in Appendix A (see example in Figure 1 below) of the GHTF Guidance document explaining the use of a Summary Technical Document (STED) to demonstrate conformity with the principles of safety and performance (http://bit.ly/GHTFSTEDGuidance).

Figure 1 ERC Example What are the Essential Requirements for Medical Device CE Marking?

Figure 1: Example of an ERC

To demonstrate compliance with the ERs, you must provide the following information by filling in the four columns of the ERC:

  1. Applicability to your device,
  2. Method used to demonstrate conformity with the ER,
  3. Reference to the method(s) used, and
  4. Reference to the supporting controlled documents.
Subparts & Common Mistakes

Completing the ERC would be easy if there were only 13 ERs, but eight of the 13 ERs have multiple requirements. For example, ER 13.3 has 14 subparts (i.e., – 13.3a through 13.3n). Each subpart must be addressed when you complete the columns of the ERC table. If any of the parts in ER 7-13 are not applicable to your device, you need to provide a justification. For example, ER 11 and its subparts are not applicable to devices that do not emit radiation. This justification must be documented in the ERC for each subpart.

When you write your justification for non-applicability of an ER, you need to be careful to provide a justification for each part of the requirement. For example, there are three sub-parts to ER 7.5. Each part is a separate paragraph, but these are not identified by a letter, as is done in ER 13.3 and 13.6. Instead, each subpart is a separate paragraph. Within those paragraphs, there is further room for confusion. For example, the third paragraph states that if you use Phthalates in a product that is intended for women or children, then you must provide a justification for its use in the technical documentation, in the instructions for use, within information on the residual risks for these patient groups (i.e., –women and children) and, if applicable, on appropriate precautionary measures.

Proposed EU Regulations

The proposed EU Medical Device Regulations (MDR) are organized into Articles and Annexes–just like the current EU Directives, and the ERs will still be the first Annex of the MDR. However, there will be 19 ERs, instead of 13. The early reviews of the proposed regulations indicated that there were no significant changes, but I have learned the hard way that you should always go to the source and verify the information for yourself. The general organization of the Essential Requirements is still the same, but there are several significant changes that will require providing additional documentation in your Technical File or Design Dossier for CE Marking. Most companies will probably submit a revised ERC to address the new requirements, but you may want to read Medical Device Academy’s review of the new ERs (http://bit.ly/NewERCGap) and prepare accordingly.

Essential Principles Checklists

Health Canada has an Essential Principles checklist (EPC) that is similar to the European ERC, and Australia has a similar document (http://bit.ly/EPCTGA) with only a few minor differences, and the Global Harmonized Task Force (GHTF) created an earlier version in 2005 (http://bit.ly/EPSafetyPerf). Health Canada will typically accept your ERC developed for the European Medical Device Directive (MDD), but a gap analysis should be performed against the Australian Regulations.

Now that the ENVI vote has passed (http://bit.ly/ENVIVotepasses) I asked a new consultant working for me to create a template for the new Essential Requirements in the proposed regulations. You can download this FREE template at: http://bit.ly/NewERCTemplate. This new template also indicates the items that were recently modified (see the redlines).

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What Does the CE Mark Mean, and What is its Purpose?

CE Marking Examples What Does the CE Mark Mean, and What is its Purpose?

The author answers the question of what does the CE Mark mean, what its purpose is related to medical devices and regulatory requirements, if applicable.

In order to facilitate trade throughout the European Economic Area (EEA), products need to be clearly identified as compliant with regional and national regulations. In the EEA, this identification is the CE Mark. “CE” is not an acronym. The mark indicates compliance of your product with the essential requirements in the applicable directive. In the case of medical devices, there are three directives:

  1. Medical Device Directive, 93/42/EEC (http://bit.ly/M5MDD),
  2. Active Implantable Medical Devices Directive, 90/385/EEC (http://bit.ly/AIMDDirective)
  3. In Vitro Diagnostics Directive, 98/79/EC (http://bit.ly/currentIVDD).

Prior to existence of these three directives, medical devices were compliant with the regulations of individual member states. These regulations were extremely detailed, and created a barrier to transport of products between the member states. With the implementation of the new approach directive (http://bit.ly/Resolution85), companies were able to CE Mark medical devices in accordance with one of the three device directives, and medical device products began to flow smoothly throughout the EEA.

Notified Body Numbers

The images at the top of this blog posting are examples of CE Marks from two of the largest medical device Notified Bodies. The four-digit numbers identifies the Notified Body (NB) that issued the CE Certificate for the medical device. This number is only used for medical devices requiring NB involvement. Therefore, non-sterile Class I medical devices that do not have a measurement function are required only to have the “CE” on their labeling. All other medical devices are required to have the “CE” with the NB four-digit number. If one of the Competent Authorities (CAs), the equivalent to the U.S. FDA in each member state, wants to determine which Notified Body is authorizing the CE Marking of a medical device, the CA will look-up the four-digit number on the following NB database (http://bit.ly/NBDatabase).

How to Reproduce the Mark

It is the legal manufacturer’s responsibility to design their own labeling with the CE and NB number—if applicable. This labeling is included in the company’s Technical File, and the NB reviews the Technical File for compliance with the essential requirements in one of the three device directives. For medical devices, the instructions for CE Marking are defined in Annex XII of 93/42/EEC. For active implantable devices, the requirements are found in Annex 9 of 90/385/EEC. For in vitro diagnostic devices, the requirements for CE Marking are found in Annex X of directive 98/79/EC.

These three Annexes are identical, and provide a graduated drawing showing the exact proportions of the “C” and “E” relative to one another. These Annexes also state that “The various components of the CE marking must have substantially the same vertical dimension, which may not be less than 5 mm.” You can obtain a free download of the mark on the Europa website (http://bit.ly/DownloadCE).

The four-digit NB number is intended to be the same boldness and font as the “CE” characters. Therefore, NBs have interpreted the requirement to specify numbers that are at least half the height of the “C” and “E”—or at least 2.5 mm. Each NB also provides instructions to legal manufacturers on how to present the CE characters with their four-digit NB number. Usually, there are a couple of different orientations that are allowed by the NB. For small products, it may not be possible to mark the device with a “C” and “E” that is at least 5 mm. Therefore, the directives waive this minimum dimension for small-scale devices. Most companies, however, will place a “C” and “E” on their labeling that is at least 5 mm in height, instead of marking parts with a “CE” that is illegible.

Use and Misuse of CE Marking

Most companies want to use CE Marking on all product labeling, even for product sold outside the EEA, because other countries recognize it and associate it with safety and performance. It is also acceptable to use the “CE” in product literature. However, it is important that it appears next to product images, or descriptions that have a valid CE Certificate. It is not acceptable to use the “CE” in a way that it might imply that other products have a CE Certificate when the products do not. It is also not acceptable to use the “CE” in a way that it might imply a corporate entity is “CE Marked.” CE Certificates are for products—not for companies.

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Medical Device CE Marking: Writing a Classification Rationale

%name Medical Device CE Marking: Writing a Classification RationaleThe author reviews considerations in “how to” write a classification rationale for medical device CE marking (i.e., questions for applying classification rules).

 CE Marking of medical devices requires technical documentation (i.e., – a Technical File or Design Dossier). One of the requirements of this technical documentation is to establish the risk class of a device in accordance with the classification rules in Annex IX. The requirement to include this classification rationale in the Technical File is not well defined in Article 9, Classification, of the Medical Device Directive (http://bit.ly/M5MDD), but the guidance document for Technical Documentation (http://bit.ly/NBMED251Rec5) clearly defines this requirement in Section 3.2 (viii). Establishing a classification rationale is the first step to establishing the regulatory pathway that will be required to CE Mark your medical device.

What are the Classifications?

There are four different classifications of medical devices in Europe: Class I, Class IIa, Class IIb and Class III. These four classifications are also referred to as “risk class.” The lowest risk classification is Class I, and the highest risk classification is Class III. Class IIa is considered a “medium risk,” while Class IIb is considered a “high risk” medical device. Notified Body involvement and a CE Certificate from the Notified Body is required for almost all medical devices distributed in Europe, however, Class I devices that are non-sterile and do not perform a measurement function do not require Notified Body involvement. Class I devices that are sterile are often referred to as “Class I-S,”but this is not a term used in the Directive. The same is true of “Class I-M” for Class I devices with a measurement function.

Applying the Rules for Medical Device CE Marking

In order to apply the classification rules as defined in Annex IX of the MDD, the following questions must be answered for the device or device family:

  1. Is the device invasive? –  Invasiveness of a device is an important criterion, because non-invasive devices are generally Class I, and there is typically no Notified Body involvement required for these devices.
  2. Is the device surgically invasive, or invasive with respect to body orifices?  If a device is surgically invasive with respect to a body orifice, Rule 5 is the most likely classification rule. For all other devices that are surgically invasive, the duration of use is important
  3. How long is the device used inside the body? The primary difference between Rules 6, 7 and 8 is the duration of use. In general, permanent implants are subject to Rule 8, and are Class IIb devices. The other surgically invasive devices are generally Class IIa devices. Devices under Rule 6 are for “transient” use (i.e., – intended for continuous use for less than 60 minutes). Devices under Rule 7 are for “short-term” use (i.e., – intended for continuous use for between 60 minutes and 30 days.). There are multiple exceptions to each rule, and these exceptions should all be considered.
  4. Is the device electrically powered (i.e., – an active device)? Active devices are subject to rules 9, 10, 11 and 12.
  5. Do any of the “Special Rules” apply? It is recommended to actually start with Rules 13-18 to ensure that one of the special rules do not apply. For example, if you are making blood bags, there is no need to read anything in Annex IX except Rule 18.
Guidance Document for Classification

Annex IX defines the classification rules for Europe, but there is also a guidance document (http://bit.ly/EUClassification) published that helps to explain the classification rules with examples. This guidance document is extremely important, because it provides clarification of rules based upon interpretations that have been made by Competent Authorities with Notified Bodies and companies. For example, critical anatomical locations are defined in Section 3.1.3: “For the purposes of the Directive 93/42/EEC, ‘central circulatory systemmeans the following vessels:…”.

When you write a classification rationale for your technical documentation, it is important to reference this document—as well as Annex IX of the MDD. Your rationale should address each of the questions above for applying the classification rules. In addition, your rationale should indicate that none of the “Special Rules” (Rules 13-18) are applicable to your device or device family.

Mixed Classifications

It is possible to have a device family, contained within one Technical File or Design Dossier, that has more than one Classification. For example, you could choose to group a family of vascular grafts together in one Technical File that are permanent implants and non-absorbable. Normally, these devices would be Class IIb in accordance with Rule 8. However, if one or more of the grafts is intended for vessels included in the central circulatory system, then these grafts would be Class III devices. If a graft can be used for either indication, then the higher classification should be applied.

Proposed EU Regulations

On September 26, 2012, the European Commission released a draft proposal for a new medical device regulation. The expected implementation transition period for these proposed regulations is 2015-2017. In Annex II of the proposed regulations (http://bit.ly/EUProposal), it specifies that the risk class and applicable classification rationale shall be documented in the technical documentation. This appears as item 1.1e) under the heading of “Device description and specification.”

The MDD defines the classification rules for medical devices in Annex IX, while in the proposed EU regulations classification, rules are now in Annex VII. The MDD also has 18 rules, while the proposed regulations have 21 rules. In order to download a Gap Analysis of the Classification Rules for CE Marking, please visit the following page on this website: http://bit.ly/gapanalysiscmda.

If you need assistance with medical device CE Marking, or you are interested in training on CE Marking, please contact Medical Device Academy at: rob@13485cert.com. Medical Device Academy is developing a webinar series specifically for this purpose. You can also call Rob Packard by phone @ 802.258.1881. For other blogs on the topic of “CE Marking,”please view the following blog category page: http://robertpackard.wpengine.com/category/ce-marking/

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Why the FDA 510k Process Needs to Change Now: A Proposed Solution

The author says three factors are accelerating the need for change to the current FDA 510k process, and offers a proposed solution.

%name Why the FDA 510k Process Needs to Change Now: A Proposed SolutionWhen a company’s marketing literature tells you how a new device is totally different from competitor products, and the 510k summary for the same new device states that it is “substantially equivalent,” you can understand why the FDA may not fully support the 510k process for innovative, medium-risk devices.

There are many things wrong with the FDA 510k process, but the concept of using a predicate device and demonstrating equivalence is inherently a wrong approach for innovative devices. A preliminary report about the 510k process was released in 2010 (http://bit.ly/510kreport). The report states, “While the concept of ‘substantial equivalence to a predicate’ is generally reasonable, CDRH’s application of this standard has, in certain cases, raised concerns.” Specifically, the use of predicate devices that were withdrawn from the market due to issues of safety or effectiveness, and the use of so-called “split predicates” may not ensure patient safety or device efficacy.

The FDA attempted to address issues identified in the report by issuing a draft guidance document for 510k submissions, but industry hated it. The FDA has also gradually requested more clinical study data to demonstrate that the new device is substantially equivalent to the predicate device. This practice results in unexpected delays and much higher costs of regulatory approval. The FDA’s published guidance for 510k content (http://bit.ly/510kContent) indicates that “Clinical data is not needed for most devices cleared by the 510(k) process.” However, more than 10% of 510k submissions now require clinical data because the 510k for predicate devices included clinical data in order to demonstrate safety and effectiveness.

More recently, the FDA issued a draft guidance document for the De Novo process (http://bit.ly/DeNovoGuidance). The De Novo process allows the FDA to reset the submission requirements for devices that are not substantially equivalent and specify new requirements. The process has been used most for new In Vitro Diagnostic (IVD) products, and it is quite similar to the concept of Common Technical Specifications (CTS) introduced for IVD products in Europe.

Why the FDA 510k Process Needs to Change Now

The simultaneous confluence of three factors is accelerating the need for change in the 510k process. First, the cost of healthcare is skyrocketing. Therefore, patients and healthcare providers are desperately searching for less expensive treatment solutions. Second, insurance providers are demanding clinical evidence that new products are more effective than existing products that cost less. Third, evidence-based medicine is becoming mainstream. Physicians are no longer accepting the word of salespeople and marketing literature. Instead, physicians demand clinical data demonstrating that products are safe and effective. Users also want detailed information regarding patient selection criteria.

The collision of these three factors has exponentially increased the value and importance of clinical data, but only 10%+ of the 510k cleared devices have clinical data at the time of product launch. Regulatory clearance to market a product is nearly useless if the product is not reimbursed, and users will not adopt its use. The modular Premarket Approval (PMA) process supports (http://bit.ly/PMAmethods) the need for preliminary safety data prior to clinical use, followed by a clinical study to demonstrate efficacy. However, 510k products are lower in risk and efficacy, and can often be demonstrated with simulated use, animal testing and cadavers.

As medical devices become more complex and innovative, bench-top testing and pre-clinical testing is not always adequate to demonstrate safety and efficacy for 510k products. Complex and innovative devices are extremely difficult to predict how the devices will interact with a broader population of users and patients, and it is difficult to predict the long-term effects of the devices—beyond the duration of a pre-market, clinical study.

The PMA process requires pre-market clinical data, but PMAs require exponentially greater amounts of data than a 510k submission, and the FDA requires supplemental approval of almost every minor change (e.g., – changing a component supplier, or changing a test method). If the PMA process is too burdensome for most devices, and the 510k process is not adequate, what is the right process for the next generation of devices?

The De Novo process offers one solution, but it is still a pre-market notification process. In order for the De Novo process to be effective for innovative devices, a Special Controls Guidance Document needs to include a requirement for both pre-market clinical studies and Post-Market Surveillance (PMS).

Pilot Parallel FDA-CMS Review Process

In 2011, the FDA initiated a pilot program to allow companies to have PMA and CMS (http://bit.ly/Medicare-Medicaid) review processes occur in parallel (http://bit.ly/ParallelReview). The concept behind this pilot program is that the same clinical data must be reviewed for PMA approval and CMS reimbursement. If the pilot program is effective, products will be approved and reimbursed at the same time. However, this pilot program is only applicable to PMA products at this time. This program could be expanded to 510k products, where clinical data is presented as part of the application, but most 510k products do not warrant a clinical study.

Another Solution

The best tool to measure the safety of a new device is a clinical study, but U.S. clinical studies focus on demonstrating efficacy. Therefore, the FDA should consider using smaller clinical studies, without comparisons to predicate devices, to demonstrate safety, rather than efficacy. This is the approach used by European Notified Bodies for medium and high-risk, innovative devices. This approach can also be integrated with a Special Controls Guidance Document for De Novo products.

For complex, innovative devices, the efficacy of the device is not reliably measured by clinical studies, because outcomes are highly dependent upon users. Pre-market clinical studies can only estimate efficacy due to the small number of users. The lack of accurate efficacy predictability is why the FDA requires PMS for many PMA products. The best tool to measure efficacy is Post-Market Clinical Follow-up (PMCF) studies—not the pre-market clinical studies the FDA uses to evaluate PMA applications. This is also the type of data that is required for CMS reimbursement and physician adoption.

Innovative devices are forcing regulations to evolve. The goal of regulators should be to produce a best-in-class method of evaluating which devices should be approved, reimbursed and adopted as the standard of care.

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What is an NB-MED?

The author defines what an NB-MED is, Team NB and their role, provides a regulatory update and some information sources.

Each time I review a list of external standards I notice at least a few references that are out-of-date. Occasionally, I am surprised and everything appears to be current, but it is almost impossible to stay current with all the external standards. The most difficult standards to maintain are those that are untracked. Untracked standards are difficult to stay current with because it requires manually checking each source to determine if a standard has been updated. One of these sources is Team NB.

Team NB

Team NB describes itself as the “European Association of Notified Bodies for Medical Device.” Team NB is an organization comprised by Notified Bodies (NBs). These NBs create guidance documents in order to clarify the interpretation of regulations in the EU. Since NBs are generating the documents, rather than Competent Authorities (CAs), it is possible for Team NB to reach a consensus more quickly than CAs. Since these documents are guidance documents, the NB-MED documents are not enforceable or binding. However, in all likelihood, your NB will interpret ISO 13485 and the MDD (93/42/EEC as modified by 2007/47/EC) in accordance with these guidance documents.

The website link I provide in my “Helpful Links” page includes many links to important guidance documents. Among the recently updated NB-MED documents is: NB-MED 2.5.2/rec 2. The “rec” is not the same as a revision. For example, rec 2 is “Reporting of design changes and changes of the quality system,” while rec 1 is “Subcontracting – QS related.” The link I have provided will land you directly on the list of NB-MED documents and the right-hand column identifies the date the document was added to the list. Therefore, if you want to know about new and revised NB-MED documents, you merely need to read the documents that are identified as being added since your last visit.

NB-MED 2.4.2/rec 2

At this time, NB-MED 2.5.2/rec 2 is the only recent addition—and you should read it. Many companies struggle with design changes, and they don’t know if the change is significant or not. Revision 8 of this document includes helpful examples. I recommend reading this document carefully, and then revising your own change notification procedure to match the document. If you don’t have a change notification procedure, your QMS auditor has been lazy. Don’t let them give you the excuse of “It’s just a sampling.” This document has been published for a long time, and the intent has not changed since 2008—just new examples to clarify the interpretations.

There is a posting from 1/14/11. This is an excellent list of all the NB-MED documents. I recommend printing this document and using it to compare against your current external standards list. There is a very recent posting from 2/7/12 that answers frequently asked questions about the implementation of EN 60601. If you don’t know what this is, you probably don’t have an active device.

On 3/27/12 there was a letter from Team NB indicating that they condemn Poly Implant Prothèse (PIP) for committing fraud (well duh). Who would endorse them?

Finally, on April 17, 2012, meeting minutes were posted from an April 5th meeting of Team NB. The NBs indicated that the medical device authorization system is good! This is not a surprise, since any other response would be a self-criticism and potentially career limiting. The minutes also indicate that the Team wants as many of the members to endorse the “Code of Conduct” (CoC) that was recently drafted by the “Big 5” NBs. So far, the acceptance of this Code is limited, but the Competent Authorities have other plans.

Competent Authorities (CAs) are currently evaluating the NBs with regard to competency for handling Class III devices. In addition, there is a plan to revise the regulations in Europe (2014 is the guess). These changes will be major. The Team NB website could be a source of information about rapid changes in the next 12 months, but for now, it’s the quiet before the storm. The Great Consolidation of European Regulators is about to begin (or maybe all the NBs will endorse the CoC and the CAs will forget about it).

 

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