Clinical Studies & Post-Market Surveillance

Articles about clinical studies, clinical evaluations, post-market surveillance and post-market clinical follow-up studies.

IFU validation is not a risk reduction – Deviation 7

1 Comment / Clinical Studies & Post-Market Surveillance, Validation / By

This article describes how to perform IFU validation before commercialization and how to conduct post-market surveillance to ensure that your IFU continues to be suitable as your user population and patient population expand.

IFU Validation and PMS IFU validation is not a risk reduction Deviation 7

Most companies create an IFU for a new product by plagiarism. They merely copy a competitor’s IFU and change the name. If a regulatory expert creates the IFU, the IFU will be nearly identical to the competitor IFU. However, if a marketing person creates the IFU, the IFU will explain how your product is different from the competitor’s product. Neither approach is practical.

Creating a risk-based IFU

EN ISO 14971:2012 identifies deviations between the ISO 14971:2007 international standard and the three EU Directives. However, deviation #7 is specific to labeling and instructions for use. Even if your product is not CE marked, you should be developing a risk-based approach to IFUs. The priority of risk controls is to eliminate and reduce risks by design, manufacture, and selection of materials. The second priority is to implement protective measures such as alarms to warn users of risks. The last priority for risk controls is to inform users of residual risks. The best practice is to utilize a risk traceability matrix to document each of the risk controls you implemented to eliminate and reduce the risks of hazards identified.

The EN version of ISO 14971 will not allow you to reduce risks quantitatively in your risk assessment for information provided to users about risks, because this type of risk control is not entirely effective. However, you are required to verify that each residual risk is disclosed to users in your IFU, and you must validate that your warnings, precautions, and contraindications are adequately identified such that users understand the residual risks. You are also required to determine any user training needed to ensure specified performance and safe use of your medical device in accordance with ISO 13485:2016, Clause 7.2.1d. Clause 7.2.2d) requires that your company ensure that user training is made available. Any user training you provide should also be validated for effectiveness.

When to perform IFU validation

Some companies ask physicians that helped them with product development review draft IFUs. However, these physicians are already familiar with your product, and your company, and they are highly skilled in the specific procedures your device will be used for. After your experts have made their final edits to your draft IFU, you now need a “fresh set of eyes.” The best approach is to validate the effectiveness of your IFU with potential users that don’t know you or your company. If your product requires animal performance testing or human clinical studies, you could use these studies to validate your IFU. However, I recommend conducting a simulated use study before conducting animal or human studies. Conducting a simulated use study before animal and human studies can prevent deviations from your documented protocols that were caused by the inadequate review of the IFUs.

Methods of IFU validation

The best method for validating your IFU is to perform a simulated use study or human factors study. The FDA published a human factors guidance document that can help you assess the risk of human factors and ergonomics. The FDA guidance requires that you identify your intended user population(s). For each individual population of users, you are required to have a minimum of 15 users for your study. If your product is not for specific indications, you may be able to select 15 users at a few sites randomly. However, if your device is intended for two different specialties, then you need 30 users–15 for each specialization.  I recommend recording a video of simulated use studies too. Videos identify small details that you might miss, and clips from the videos are useful in creating training videos for future users.

Gathering Post-Market Surveillance

Post-market surveillance is not just asking customers if they are satisfied. You need to continue to monitor adverse event databases, your complaint database, and any service records to determine if there are any new risks and to verify that the risks you identified were accurately estimated concerning severity and probability of occurrence of harm. Clinical studies and PMS are the only way you can gather data regarding the likelihood of occurrence of harm. When you design your post-market surveillance questions, make sure you include questions explicitly targeting the residual risks you identify in your IFU. You should also ask, “What indications do you use this device for. Specifically, please identify the intended diagnosis, treatment, and patient populations.” This wording is more effective than asking if a physician is using your product “off label.”

Revalidation of IFU after labeling changes

Changes to labeling and IFUs should always be considered design changes and may require revalidation. If the switch is in response to a complaint or CAPA, then you must revalidate the IFU and labeling to verify the effectiveness of your corrective action. Any validation should be documented, reviewed, and approved before implementation, and acceptance criteria should be determined ahead of time. Your acceptance criteria should be quantitative, so you can objectively determine if the change is valid or not. You might be able to copy your previous IFU validation protocol or simulated use protocol and simply repeat the validation precisely as you did before with new users. However, sometimes the reason why the IFU was not 100% effective in the past is that the risk you are addressing in the revised IFU was not evaluated adequately in the original simulated use protocol.

New webinar for risk-based IFU validation and PMS

If you want to learn more about using a risk-based approach to developing IFUs, validating IFUs, and performing post-market surveillance to monitor the effectiveness of your IFU, then please click on the webinar link below.

IFU Validation Webinar Button 300x62 IFU validation is not a risk reduction Deviation 7

If you are interested in ISO 14971 training, we were conducting a risk management training webinar on October 19, 2018.

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MEDDEV 2.7/1 rev 4: How will your clinical evaluation change?

1 Comment / CE Marking, Clinical Studies & Post-Market Surveillance / By

Article overviews of the new MEDDEV 2.7/1 rev 4 for clinical evaluation of medical devices, including a quality plan to comply with the latest revision.

MEDDEV 271 rev 4 MEDDEV 2.7/1 rev 4: How will your clinical evaluation change?

What’s new in MEDDEV 2.7/1 rev 4 for clinical evaluations?

The third and fourth revisions both give manufacturers three choices: 1) a clinical literature review, 2) performing a clinical study, and 3) a combination of literature review and performing a clinical study. However, the fourth revision is completely re-written. The fourth edition is 19 pages longer, and it is now much harder to use the “literature only” route. The fourth revision includes stringent requirements for demonstrating equivalence between another device and your device. Therefore, many companies are now struggling to update their clinical evaluation reports to satisfy this new guidance document.

Overview of the content in MEDDEV 2.7/1 rev 4

The third and fourth revisions of the guidance both have a 5-stage process for clinical evaluations, but in the third revision, only articulated stages 1 through 3 as stages leading up to writing a clinical evaluation report. The figure in section 6.3 of revision four now identifies a planning Stage 0, and the writing of the clinical evaluation report is referred to as Stage 4. Therefore, there is a lot more detail describing the planning and report writing stages than there was in revision 3. In addition, Stage 2 (Appraisal of clinical data) has been expanded from a single page to eight pages.

Based upon the above changes, you can infer that Competent Authorities have been unsatisfied with the quality of clinical data being provided to support the essential requirements for safety and performance. In turn, Notified Bodies are expected to be much more critical of the data presented, and more guidance is provided to manufacturers. There is also much more guidance and more examples provided in the appendices, while the 12-page clinical evaluation checklist that was provided in revision three has been replaced by one page of bulleted items for Notified Bodies to consider.

Demonstration of equivalence

It is no longer sufficient to list several devices that are similar to your device and include those devices in your search of clinical literature. Now you may only select one device for equivalence. You must also provide a thorough analysis of equivalence with that device based on clinical, technical, and biological characteristics. This comparison includes providing drawings or pictures to compare the size, shape, and elements of contact with the body.

Updating clinical evaluations

The new European Medical Device Regulations (EMDR) is expected to specify minimum requirements regarding the frequency of updating clinical evaluations, but MEDDEV 2.7/1 rev 4 discusses this in section 6.2.3. The frequency of updating your clinical evaluations must be justified and documented. Many considerations for this justification are discussed, but the end of that section indicates that devices with significant risks (e.g., implants) require at least annual updates to the clinical evaluation report. For devices with non-significant risks, and where the device is well established (e.g., a long clinical history), 2-5 years is the range of possible frequency. Longer than five years are not allowed.

Who should perform clinical evaluations?

Many device manufacturers are receiving nonconformities because the evaluators are not sufficiently qualified, or the qualifications are not documented. The qualifications must follow 6.4 of the new guidance, and the qualifications set by your company should be documented in your procedure for clinical evaluations. You will need to document these qualifications with more than an abstract, but you will also need to present a declaration of interest for each evaluator. Evaluators need knowledge in clinical study design, biostatistics, information management, regulatory requirements, and medical writing. Evaluators also need knowledge specific to the device, its technology, and its application. Evaluators must also have a higher education degree in the field and five years of experience or ten years of experience if they do not have a higher education degree. Due to the breadth and depth required of qualifications required, it may be necessary to assemble a team to perform evaluations.

Creating a quality plan for compliance with MEDDEV 2.7/1 rev 4

Seven steps need to be included in your quality plan for compliance with MEDDEV 2.7/1 rev 4:

  1. update your external standards to replace MEDDEV 2.7/1 rev 3 with MEDDEV 2.7/1 rev 4
  2. revise your procedure and associated templates for a literature review and clinical evaluation report to meet the requirements of MEDDEV 2.7/1 rev 4
  3. document the qualifications of evaluators for clinical evaluations
  4. document a plan/schedule for updating your clinical evaluation reports for each product family
  5. train evaluators, regulatory personnel and any applicable internal auditors on the requirements of MEDDEV 2.7/1 rev four and updated procedures and forms
  6. begin updating clinical evaluations according to your plan
  7. perform an internal audit of your clinical evaluation process

Learning more about MEDDEV 2.7/1 rev 4

If you are interested in learning more about this revised guidance document, please register for our live webinar on Friday, January 27 @ Noon EST by clicking on the button below.

Click Here 300x115 MEDDEV 2.7/1 rev 4: How will your clinical evaluation change?

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Class 1 Device Requires Clinical Evaluation Report (CER) too!

1 Comment / Clinical Studies & Post-Market Surveillance / By

Article explains how to write a clinical evaluation report (CER) for CE Marking Class 1 medical devices when there is little or no clinical study literature available. The history behind this European CE Marking regulatory requirement is explained as well.

Clinical study for this e1446901425122 Class 1 Device Requires Clinical Evaluation Report (CER) too!

In 2010 the European Medical Device Directive was updated to include many tougher regulatory requirements for medical devices of all types. One of this changes is criticized frequently by industry–the change to make essential requirement 14 to a general requirement for all devices. That requirement is now essential requirement 6a in Annex I of the current MDD (93/42/EEC as modified by 2007/47/EC). The general requirements are required for all devices–event products that do not require a Notified Body’s involvement.

Typical Search Strategy for a Class 1 Device

Class 1 devices do not typically have clinical studies performed for three reasons:

  • the products are low in risk and therefore do not require clinical studies for regulatory approval
  • the products have been on the market for a long time and therefore there is little innovation in these products
  • clinical investigators are not interested in researching devices that have been used for a long time

Since there is typically no requirement for a clinical study for a Class 1 device, companies will perform a literature search in order to meet the requirements of Essential Requirement 6a. That search will typically result in articles that mention the device or a competitor device, but the device is typically just part of a clinical study that was performed for another device (i.e., the device of interest is merely an accessory). If there are clinical studies, the studies may be quite old and it may be more helpful to search for review articles first. In the end, you may end up finding no clinical studies for the type of device you are designing, but a clinical evaluation report is still required for CE Marking for Class 1 devices.

It may be painful for you and your company to conduct a clinical evaluation, even using the literature route, when there are no new clinical studies to find. However, the CE Marking regulations are written to address all devices and material innovations alone are driving the need for companies to reconsider the “state of the art” for even Class 1 devices. It is also important to consider emerging issues such as infection control with antibiotic resistant strains and the trend toward using disposable instruments such as drill bits.

Reference Articles for Clinical Evaluation Reports and PMS

I have published 3 previous blogs specifically on the topic of clinical studies and post-market surveillance over the past couple of years. Please click here if you are looking for more information on this topic.

Procedure/Template for Class 1 Device Clinical Evaluation Report (CER)

If you are looking for a procedure (SOP) and associated literature search protocol template for a clinical evaluation report (CER) please click here. The purpose of this 6-page procedure is to define the process for performing a clinical evaluation of literature in accordance with MEDDEV 2.7/1. There is also template provided for performing a literature search (i.e., TMP-004).

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Post-market surveillance plans: How to write one for CE Marking.

2 Comments / Clinical Studies & Post-Market Surveillance / By

This article explains how to write a post-market surveillance plan for CE Marking and how to determine if a post-market clinical follow-up (PMCF) study is required.

Screenshot 2015 12 15 at 6.18.57 AM Post market surveillance plans: How to write one for CE Marking.

A post-market surveillance (PMS) plan is only required for the highest risk devices by the FDA (i.e., typically devices that require a PMA or premarket approval). For CE Marking, however, all product families are required to have evidence of post-market clinical follow-up (PMCF) studies or a justification for why PMCF is not required.

Why is a post-market surveillance plan a “hot button” with auditors recently?

Post-Market surveillance is an area of emerging concern around the world. Not just a procedure for PMS, but an actual product-specific plan for gathering post-production data about your product or product family. Product registries, the anticipated launch of Eudamed, and the implementation of UDI regulations are part of this industry-wide movement. The FDA has articulated the US plan for strengthening PMS in a guidance document. At the same time, the European PMS efforts are being debated as a central part of the new European Medical Device Regulations.

The biggest mistake I see 

The biggest mistake I see is that manufacturers refer to their PMS procedure as the PMS plan for their product family, and they say that they do not need to perform a PMCF study because the device is similar to several other devices on the market. Manufacturers need to have a PMS plan that is specific to a product or family of products.

How often is post-market surveillance data collected?

Your post-market surveillance procedure needs to be updated to identify the frequency and product-specific nature of post-market surveillance for each product family, or a separate document needs to be created for each product family. For devices that are high-risk, implantable, or devices that have innovative characteristics, the manufacturer will need to perform some PMCF studies. Even products with clinical studies might require PMCF because the clinical studies may not cover changes to the device, accessories, and range of sizes. MEDDEV 2.12/2 provides guidance on the requirements for PMCF studies, but most companies manufacturing moderate-risk devices do not have experience obtaining patient consent to access medical records to collect PMCF data–such as postoperative follow-up data.

Additional Resources

Medical Device Academy has created a post-market surveillance plan template that you can download for free. If you are looking for a procedure for post-market surveillance, please click here. If you are interested in learning more about PMS and PMCF studies, we also have a webinar on this topic.

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PMCF – Is a post-market clinical follow-up study required?

3 Comments / Clinical Studies & Post-Market Surveillance / By

This article explains how to determine if your medical device requires a post-market clinical follow-up (PMCF) study for CE Marking. This is currently a non-existent requirement for most 510k submissions. Still, it is an area of emerging concern for all medical device regulations, and this article explains why substantial equivalence is not enough.

F1.large PMCF Is a post market clinical follow up study required?
Why post-market clinical follow-up is an area of emerging concern.

For CE Marking applications of medical devices, all medical devices must have evidence of a post-market clinical follow-up (PMCF) study protocol or a justification for why a post-market clinical follow-up (PMCF) study is not required. The biggest mistakes I see are that manufacturers refer to their post-market surveillance (PMS) procedure as the post-market surveillance (PMS) plan for their product family. They say they do not need to perform a post-market clinical follow-up (PMCF) study because the device is similar to several other devices on the market (i.e., substantially equivalent).

Why Substantial Equivalence Isn’t Enough

This rationale fails the technical review of most CE Marking submissions because although products can be approved for CE Marking based upon substantial equivalence, the manufacturer must continue to monitor the performance of the device after the product is launched to make sure of two critical things:

  1. Is the substantially equivalent device as safe and efficacious as the predicate device?
  2. Are there new risks that are identified when the device is used for a long duration (e.g., implanted) by a broader user population or to treat a broader patient population / broader indication for use?

A post-market clinical follow-up (PMCF) study MIGHT be needed

If you have a high-risk device that is implantable, has an innovative design, and you are using moon rocks for the patient contacting materials, you need a post-market clinical follow-up (PMCF) study. If you make a generic version of a sterile bandage with a cartoon character for decoration, you don’t need a post-market clinical follow-up (PMCF) study. Unfortunately, most products fall into the “might be needed” category rather than a “yes” or “no.” If you have any experience in regulatory affairs, you know that regulators love guidance documents and systematic evaluation methods. Here’s my systematic method of evaluation…

Step-by-Step Recommendations

Step 1 – Read MEDDEV 2.12/2.

Step 2 – Make a table with each of the 17 “might be needed” categories from the guidance document in the far left column.

Step 3 – In the second column, indicate whether the risk category from the table applies to your device–” yes” or “n/a.”

Step 4 – As with all valuable checklists, you must explain your non-applicability rationale wherever the category doesn’t apply. Enter your explanation in the third column next to the “n/a”…PS – nobody cares if the “n/a” is capitalized.

Step 5 – If you typed “yes” in the second column, then you need to provide a cross-reference to the information in your technical file that explains how you address this risk. There are three places you can look: 1) your design requirements trace matrix (if you have one that looks like mine), 2) as a risk control in your risk analysis that you performed during the design process before “design freeze”, and 3) in your clinical evaluation report. Ideally, you can easily cross-reference to a section of your controlled document that is in outline format.

Note: Now, you have another reason to make that document a controlled document with an outline format.

Step 6 – After you add a cross-reference to the risk control(s) in your table, you need to indicate whether the risk controls are adequate. “Yes” is probably the answer only if you can cross-reference to a state-of-the-art guidance document or harmonized standard that has been implemented as a pre-market risk control to evaluate the specific risk. The tests are seldom adequate for the longevity of implants, usability by all intended users, and patient satisfaction, while usability and patient selection are often only evaluated by clinical studies. If the tests and pre-market clinical studies are not adequate, then “No” is your answer, and you need to conduct a post-market clinical follow-up (PMCF) study to address that specific residual risk. 

Step 7 – If you indicate that your pre-market risk controls are adequate, then in your post-market surveillance plan, you can indicate “no post-market clinical follow-up (PMCF) study required.” However, if you cannot verify that your pre-market risk controls adequately address one of the 17 risk categories identified in MEDDEV 2.12/2, you may need a post-market clinical follow-up (PMCF) study.

When do existing products suddenly develop the need for a post-market clinical follow-up (PMCF) study?

Even products with pre-market clinical studies might require post-market clinical follow-up (PMCF) because the clinical studies may not cover changes to the device, accessories, and range of sizes. Additionally, specific risks of implantable products cannot be assessed during the average duration of a clinical study (e.g., how long will an implant last). MEDDEV 2.12/2 provides guidance on the requirements for post-market clinical follow-up (PMCF) studies. Still, most companies manufacturing moderate-risk devices do not have experience obtaining patient consent to access medical records to collect post-market clinical follow-up (PMCF) data–such as postoperative follow-up data. If you don’t have expertise in collecting this patient-specific data in a compliant way, you should consult a clinical research associate (CRA) or engage a clinical research organization (CRO). My procedure on clinical studies (SYS-009) explains some of the basics.

PMCF can also help you develop new products

PMS data is also required as an input to your design and development process. If you identify potential adverse events (I.e., incidents that require regulatory reporting), then you should specifically design your PMCF study to collect this safety data. Investigations of adverse events and potential adverse events can be used to help you design a safer technology for the next generation of your product. In fact, the FDA fosters this type of innovation through the Safer Technologies Program (i.e., STeP). 

Additional Resources

I also wrote an article in BoneZone: “Post-Market Studies in Lieu of Clinical Studies”. This article emphasized the increasing need for clinical data for device approval and reimbursement, but it focused on using post-market clinical follow-up (PMCF) study data as an alternative to conducting a traditional, pre-market clinical study.

Procedures & Training Related to PMCF

The following procedures and training are available for purchase from our website:

  1. Post-Market Surveillance Procedure
  2. PMCF Webinar
  3. Clinical Evaluation Report (CER) Procedure

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Avoiding Clinical Evaluation Report (CER) Pitfalls

1 Comment / CE Marking, Clinical Studies & Post-Market Surveillance / By

This article explains the key steps to preparing a successful clinical evaluation report (CER) for the submission of a technical file for medical device CE Marking.

Photo for Clinical Evaluation Report Blog 1024x931 Avoiding Clinical Evaluation Report (CER) Pitfalls
Once someone shows you the most efficient path, climbing the wall no longer seems so challenging.

Essential requirement 6a, the clinical evaluation report (CER), is required for all medical devices that are CE Marked. Up until the Medical Device Directive (MDD) was modified in 2010 (i.e., 2007/47/EC), only high-risk devices required a clinical evaluation report. After the MDD was changed, a CER was needed for all medical devices–even Class I devices that do not require a Notified Body. To help manufacturers understand the expectations and comply with this requirement, a guidance document was released for clinical evaluations in December of 2009 (i..e., MEDDEV 2.7/1 rev 3). MEDDEV 2.7/1 indicates that are there are three options for preparing a clinical evaluation report:

  1. perform a clinical study and summarize the results,
  2. perform a literature search of clinical study articles, or
  3. a combination of the first two options.

Preparing clinical evaluations are tedious but not necessarily challenging. I like to compare the preparation of clinical evaluation reports to bouldering problems. Once someone shows you the most efficient path, climbing the wall no longer seems so challenging.

Literature Search Protocol (TMP-004)

Section 6.1 of the guidance document indicates that a literature search protocol should be used to identify, select, and collate clinical study articles for a literature search. Critical elements of your search protocol should include: which search databases you selected and why, intended use and indications for the use of the device, similar devices that are on the market and a comprehensive date range starting with the earliest clinical studies or the last date of a previous clinical evaluation. Your search protocol should specify inclusion and exclusion criteria, and you will need a systematic method for tracking your results.

I created a protocol template, TMP-004, which I use to perform clinical literature searches. The protocol includes suggested databases for literature sources, a list of adverse event databases, and a database for clinical investigations that should be included in your search. The protocol also includes criteria for evaluating the results of the search. Evaluation criteria should consist of the type of clinical study, the number of patients, the study design, etc.

Qualified Individuals

To conduct a clinical evaluation, you need a cross-functional team–as you should have for all post-market surveillance and risk management activities. One of the team members should be an expert in the design of the device or similar devices. Another person should be an expert in performing literature searches to ensure that the review of the literature is comprehensive. Finally, the team needs at least one person with a clinical research perspective to evaluate the clinical data critically. The qualifications of these individuals should be described in an appendix of your clinical evaluation report, and typically this is done by providing a copy of each person’s resume or curriculum vitae. The omission of these qualifications or the failure to rely upon clinical experts to review the data is a common nonconformity raised by technical reviewers from Notified Bodies.

Selection of Databases

When you are writing a literature search protocol, it is essential to specify why you selected certain search databases and to ensure that you include more than one database. Each literature search database has different strengths and weaknesses. Suppose you are not sure which databases to choose and why this is an indication that you need assistance with the literature search methodology. This is typically part of the process for teaching doctoral candidates how to prepare for writing their dissertation. Therefore academic credentials of the individuals contributing to the post-market surveillance activities are relevant.

Selection of Key Words

Often certain keywords are more common in the title of clinical study articles than others, and these keywords can help narrow the number of literature search results dramatically. Therefore, it is recommended to perform some preliminary searches with different keywords to get a sense of which terms will be the most efficient in helping you to identify the articles that meet your inclusion criteria. These terms can also be used to exclude large numbers of articles that are not relevant. For example, if there are a large number of porcine studies in the literature, you might exclude the term “porcine” to ensure that animal studies involving pigs are excluded from your search results.

Inclusion & Exclusion Criteria

Many times articles will mention a keyword or the name of a device, but the device is only mentioned as an accessory in a study rather than being the focus of the study. If the article only says the device but doesn’t include clinical data regarding its use, then the article should be excluded. Only human studies should be included in your results, and if there are a large number of published studies, you may purposely choose to exclude articles with the terms “case study” that may only include one or two patients.

Addressing Risks

Your clinical evaluation report (CER) is intended to assess the safety of your device by identifying any potential risks that you may have overlooked in your risk analysis and to help you estimate the severity of harm and the probability of occurrence for those harms. It is recommended to perform a preliminary hazard identification and risk analysis before conducting the clinical evaluation to identify the most likely risks associated with the device. Each of these risks should be mentioned explicitly in the clinical evaluation–even if the clinical study data does not identify the risk. If a specific risk is identified during your hazard identification with no clinical data to support the safety of the device related to that risk, then it may be necessary to conduct a clinical study or a post-market clinical follow-up (PMCF) study to evaluate the risk further.

Review of Post-Market Surveillance

When your device is first submitted for CE Marking, you may not have any clinical history with the device, and it is only possible to estimate risks. For this reason, it is important to include post-market surveillance information about similar products as an input to your clinical evaluation process. After your product is launched, you will have a complaint handling data and adverse event data specific to your device. Therefore, you should periodically review the post-market surveillance data and compare it with the initial risk estimates. If the results are similar, then the risk analysis does not need to be updated immediately. If the post-market surveillance results are substantially different from your risk estimates, you should update your clinical evaluation report earlier than planned and update your risk analysis. I recommend stating this conclusion in each report summarizing post-market surveillance data–including a specific recommendation to maintain the current plan for the frequency of conducting clinical evaluations or a recommendation to change the schedule.

Appraisal of Clinical Literature

Your appraisal of clinical literature needs to be systematic and documented. Technical reviewers expect clinical data that supports and detracts from the conclusion that your device is safe and effective for the desired indications. Therefore, you should not exclude articles simply because the findings are negative. You need to include appraisal criteria in your protocol to ensure that the evaluation of literature search results is objective and systematic. I have included a recommended grading system for clinical study articles in my procedure for clinical evaluation reports (i.e., SYS-041). The graded results of each article identified are then summarized in the Appendices of the clinical evaluation report (CER).

Review and Update of Clinical Evaluation Reports (CERs)

Preparing a clinical evaluation report (CER) is time-consuming, but the report is also a living document. Therefore, you need to have a post-market surveillance plan for each medical device or device family that specifies the frequency of performing a review and update of your clinical evaluation report (CER). Depending upon the nature of your device and the amount of clinical history you have with that device, you may also need to conduct a post-market clinical follow-up study (PMCF). Any post-market surveillance that you conduct should be included as an input to the clinical evaluation report. This is why my literature search protocol includes adverse event databases.

Procedures & Templates

If you are looking for a procedure and literature search protocol for preparing a clinical evaluation report (CER), please click here. If you are interested in learning more about post-market surveillance and post-market clinical follow-up (PMCF) studies, we also have a webinar on this topic.

Photos shown in this article are two of my sons, Alex Beshay (13) and Bailey Packard (14), at this weekend’s bouldering competition at PETRA Cliffs in Burlington, VT. Every member of our family is an avid rock climber, including my 3-year-old daughter.

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TGA Joint Registry Report

1 Comment / Clinical Studies & Post-Market Surveillance / By / , ,

Therapeutics Goods Administration (TGA) published an assessment of Australia’s national joint replacement registry report.%name TGA Joint Registry Report

TGA Joint Registry Report

Annually the Therapeutics Goods Administration (TGA) publishes its assessment of the Australian Orthopaedic Association’s National Joint Replacement Registry (AOANJRR) report. This data is crucial to orthopedic companies as a recent source of post-market surveillance for their products and competitors and the development of Post-Market Clinical Follow-up (PMCF) study protocols.

You can download the most recent annual report, and the thirteen supplemental reports, from the following website: (http://bit.ly/AOA2013Reports). As you can see from the list below, this release is more extensive than previous annual reports that did not include the supplementary reports. This should be especially important for spinal companies that will be reclassifying (http://bit.ly/gapanalysiscmda) their CE Marked products from Class IIb to Class III and submitting a Design Dossier in 2014/2015.

2013 Annual Report

  • Hip & Knee Arthroplasty (September 1999 to December 2012) – 213 pages

2013 Supplementary Reports

  1. Analysis of State and Territory Health Data All Arthroplasty – 19 pages
  2. Cement in Hip & Knee Arthroplasty – 15 pages
  3. Demographics and Outcomes of Elbow & Wrist Arthroplasty – 32 pages
  4. Demographics and Outcome of Ankle Arthroplasty – 11 pages
  5. Demographics and Outcomes of Shoulder Arthroplasty – 65 pages
  6. Demographics of Hip Arthroplasty – 28 pages
  7. Demographics of Knee Arthroplasty – 23 pages
  8. Demographics of Spinal Disc Arthroplasty – 11 pages
  9. Lay Summary 2013 Annual Report Hip and Knee Replacement – 13 pages
  10. Metal on Metal Total Conventional Hip Arthroplasty – 13 pages
  11. Mortality following Primary Hip and Knee Replacement – 10 pages
  12. Revision of Hip & Knee Arthroplasty – 21 pages
  13. Unispacer Knee Arthroplasty – 6 pages
Post-Market Clinical Data

The requirement to conduct PMCF studies is not new. The release of MEDDEV 2.12/2 rev 2 in 2012 increased the orthopedic industry’s awareness of this tool’s purpose and importance. In Europe, Notified Bodies are required to verify that manufacturers have included a PMCF protocol as part of the Post-Market Surveillance (PMS) plan. The requirement for PMCF studies is found in Annex XIV of EU MDR. It states that “PMCF shall be understood to be a continuous process that updates the clinical evaluation.” 

Most orthopedics manufacturers attempt to provide a justification for not conducting PMCF studies, yet implant recalls, and the prevalence of revision surgery have increased the scrutiny around these justifications. Hamish Forster, a former Notified Body specialist at TUV SUD, wrote a white paper on “The Post-Market Imperative: Understanding the requirements for effective post-market clinical follow-up.”

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