CE Marking

Sep 10 2013

CE Marking Routes to Regulatory Approval

3 Comments / CE Marking / By Robert Packard / CE marking

The author reviews the conformity assessment process contained in Annexes VII, II, V, and III related to a company seeking CE Marking regulatory approval.

CE Marking of medical devices requires technical documentation (i.e., – a Technical File or Design Dossier)—regardless of the device classification. However, the classification of the device has a significant impact on the regulatory approval pathways available to your company. Therefore, the first step in the process of CE Marking of medical devices is to determine the risk classification (http://bit.ly/riskclass). There are four device classifications: Class I, IIa, IIb, and III.

Once your company has determined the risk classification of the device, then you must determine which conformity assessment procedure you will follow to receive CE Marking approval. The conformity assessment procedures available for each classification are identified in Article 11 of the Medical Device Directive (http://bit.ly/M5MDD), and additional detail is provided in the various Annexes (i.e., – Annex II, III, IV, V, VI, and VII). The following table below summarizes the options for each classification:

If your product is a Class I device that is non-sterile and non-measuring, then you will not require a Notified Body (NB). However, all other products will require your company to select a NB (http://bit.ly/SelectingRegistrar).

Annex VII – Declaration of Conformity

If your company does not require NB involvement, then you will be able to issue a Declaration of Conformity In accordance with Annex VII. You will also need to register your product with one of the Competent Authorities (CA) in Europe. CAs are the U.S. FDA equivalent in each EU member state. The following is a list of contact information for all the CAs: http://bit.ly/ContactPoints. If your company does not have a physical presence in Europe, you will also need to select a European Authorized Representative (AR). My recommendation is to select an AR that is one of the 15 members of the European Association of Authorized Representatives (http://bit.ly/EAARMembers).

Annex II – Full Quality Assurance

Most companies use the Annex II conformity assessment process to achieve CE Marking. In this process, the NB reviews your Technical File for conformity and also reviews your quality system for conformity with regulatory requirements in the applicable directives. As part of the Annex II process, the NB will audit your design process to ensure that you have adequate design controls and that your process for establishing and maintaining a Technical File is adequate. Once your company has adequately addressed any findings from the audit, the NB will issue your company a Full Quality Assurance (FQA) CE Certificate in accordance with Annex II.3. Once you have the Certificate, your company will be able to launch new products without prior approval from the NB. The only requirement is that the new products are within the scope of the Annex II.3 certificate.

Annex V – Production Quality Assurance

The Annex V conformity assessment process is the most common route to CE Marking for companies that outsource product design to a third-party. If your company outsources design, Clause 7.3 is excluded from your ISO 13485 Certification, and you cannot demonstrate “Full Quality Assurance.” Therefore, the NB will issue an Annex V certificate for “Production Quality Assurance.” Annex IV and Annex VI are alternate conformity assessment procedures, but these are used less frequently for medical devices and are outside the scope of this blog.

Annex III – Type Examination

The Annex III conformity assessment process is a type of examination that is performed for higher risk devices where the company does not have an Annex II certificate. This type of examination involves a review of your company’s design dossier, and the NB issues a Type Examination CE Certificate. This Certificate cannot be used alone for CE Marking. Type Examination Certificates must be used in conjunction with another CE Certificate, such as the Annex V certification for Production Quality Assurance. This combination would be used for Class IIb and Class III devices in place of an Annex II CE Certificate.

If your company needs help with CE Marking, including training on the medical device directive, please contact Medical Device Academy at rob@13485cert.com. We are also developing a webinar series for this purpose. If you interested in more services, try viewing the following blog category page: http://bit.ly/CEMarking.

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Sep 5 2013

How to write a CE Classification Rationale

Leave a Comment / CE Marking / By Robert Packard / CE marking, Medical Device

This article explains how to write a CE classification rationale for medical devices compliant with Annex VIII of the EU MDR.

Note: Blog page is under construction

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 CE Marking device 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 classification rules for medical device CE Marking

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

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.
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
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.
Is the device electrically powered (i.e., – an active device)? Active devices are subject to rules 9, 10, 11 and 12.
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 VIII 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 system’ means 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.

EU MDR – Regulation (EU) 2017/745

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 VIII. 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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Jun 11 2012

What is an NB-MED?

4 Comments / CE Marking / By Robert Packard / Competent Authorities, External Standards, Guidance Documents, Medical Device, NB, NB-MED, Notified Body, Team NB

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

Each time I review a list of external standards, I notice at least a few out-of-date references. 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 demanding standards to maintain are those that are untracked. Untracked standards are difficult to keep 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 Devices.” Team NB is an organization comprised of Notified Bodies (NBs). These NBs create guidance documents 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 two 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

NB-MED 2.5.2/rec 2 is the only recent addition, and you should read it. Many companies struggle with design changes and don’t know if the change is significant. 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. You probably don’t have an active device if you don’t know what this is.

On 3/27/12, Team NB sent a letter 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 5 meeting of Team NB. The NBs indicated that the medical device authorization system is excellent! This is not a surprise since any other response would be 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 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 European regulations14 the guess). These changes will be significant. The Team NB website could be a source of information about rapid changes in the next 12 months, but 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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May 29 2012

What is a MEDDEV?

1 Comment / CE Marking / By Robert Packard / 2007/47/EC, 93/42/EEC, Annex X 1.1c, Authorized Representatives, CE Mark, Class III, M5 MDD, MEDDEV

The author defines what a MEDDEV is, recent updates, and information resources to learn more.

The most important part of my website is “Helpful Links.” These are the links that I use most in Regulatory Affairs. It started as an auditor’s toolbox, but now I am morphing it into a place to review updates to regulatory requirements and external standards. The MEDDEV’s are on the top of my list. These are the guidance documents written by Competent Authorities. Still, most of the Notified Bodies treat them as requirements and often write nonconformities against at least one of them: MEDDEV 2.12/1 – Medical Device Vigilance System.

Many companies rely on RSS feeds to keep them current on the latest external standards, but this doesn’t work for a MEDDEV. For MEDDEV’s, your best bet is to go to the source. Sure, you can hire a consultant that will try and keep you current. You can also wait until your NB auditor lets you know the hard way (i.e.,. – time to write another administrative CAPA).

For those of you who don’t know the source, it is my #1 “Helpful Link”:

http://ec.europa.eu/health/medical-devices/documents/guidelines/index_en.htm

When asked how to keep current, my advice is to have a systematic process for checking various sources of external documents. At a minimum, you should be checking all of the possible sources just before each Management Review. This will give you something to include for the requirement in clause 5.6.2h) of the ISO 13485:2003 Standard. “More preferably,” as lawyers would say, check out the website link above at least once per month. For those of you that are completely out of touch, and those that just fell off the University hayride, the following explains why you can’t get away with saying:

“There haven’t been any new or revised regulatory requirements since the last Management Review.”

MEDDEV Updates

There were several updates to the MEDDEVs released as supporting documents for the M5 version of the MDD (93/42/EEC as modified by 2007/47/EC). Specifically, there were four in December 2009 and one in June 2010. Then there were two more MEDDEVs released in December 2010 related to clinical study requirements in Europe. In January 2012, another six MEDDEVs were released, and one more was released in March. Not all of these updates apply to every company, but every RA professional working on CE Marked products has been busy readying themselves to sleep at night.

I could spend some time here telling you a couple of sentences about each of these new MEDDEVs, but someone already did that for me:

http://www.eisnersafety.com/eu-medical-device-meddevs-guidance-docs-newly-rlsed-or-updated/#.T8Oml7Dy-So

One fellow blogger indicated that the MEDDEV 2.5/10, about Authorized Representatives (ARs), was disruptive:

http://medicaldeviceslegal.com/2012/02/09/new-meddev-on-authorised-representatives-everything-you-know-is-wrong/

I don’t agree with Erik Vollebregt about it being disruptive. Erik feels that we can all expect substantial revisions in the AR contracts, but I think the Germany AR’s I have worked with were already moving in this direction. Emergo has been a strong AR all along—with a distinctly more friendly Dutch style to their processes. In the end, I just don’t see Notified Bodies (NBs), making these contracts a priority initiative. I think we’ll see more auditors verifying that contracts are in place and current, but I don’t expect auditors to receive guidance on how to review contracts anytime soon.

The real changes will be in the smaller AR’s that are not European Association of Authorized Representatives (EAAR) members. The Competent Authorities (CAs) have been knocking on the door of various “wannabee” AR’s for a few years now. I think they have done an excellent job of shutting down illegitimate representatives, and the member companies of EAAR (http://www.eaarmed.org/) have done well in raising awareness. The next logical step was to provide some guidance so that there is more consistency among the ARs. I see this as just the beginning of the CA’s moving toward one approach.

Erik wrote another article about MEDDEV 2.12/2 on the subject of Post-Market Clinical Follow-up (PMCF):

http://medicaldeviceslegal.com/2012/01/17/new-eu-guidance-on-post-market-clinical-follow-up-studies-published-and-other-meddev-guidance-announced/

Erik just touched on this MEDDEV briefly, but if your company is a manufacturer of a Class III device that is CE Marked—YOU NEED TO READ THIS MEDDEV!

MEDDEV Whitepaper

As in all things post-market related, BSI has taken the lead by publishing an article that is almost as long as the original MEDDEV. This white paper was written by Dr. Hamish Forster, BSI’s Orthopedic & Dental Product Expert, and the document is called “The Post-Market Priority.” I think you can only obtain a copy of this white paper by requesting it from BSI online, but the customer service person that follows up is quite polite.

BSI’s leadership role in PMCF is not new, either. Gert Bos gave a presentation that highlighted the importance of PMCF back on March 31, 2010:

http://www.bsigroup.nl/upload/Presentatie%2031%20maart%20-%20Gert%20Bos.pdf

My advice for anyone that has a Class III device that is CE Marked is to read this MEDDEV a few times, Annex X 1.1c of the MDD, read the whitepaper, and review these presentations by Gert Bos. This will help you prepare for what is coming. For those of you that think you know something about PMCF and have justified why your company doesn’t need to do it, think again. You should review the 16 bullet points in the MEDDEV on pages 14 and 15 (17 bullets in the whitepaper, but one was just split into two parts). Identify how many of these points apply to your Class III device. The more points that apply to your product, the more extensive the NB’s will expect your PMCF plans to be.

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