By: Ludger Möller

News and Views

October 2007

Content:
HIGH PRIORITY

Dear valued Client,

Update of the Medical Devices Directives

Now it is out. The document which updates the three Medical Devices Directives has been published. We informed you in May of the update being approved by the European Parliament.

The update will affect the Active Implantable Medical (AIMD), the Medical Devices (MDD) and the In Vitro Diagnostic Medical Devices Directive (IVDD). This update is the first major overhaul of those three directives. Let’s call throughout this document the updates simply “directive”. The directive can be found here:

http://eur-lex.europa.eu/LexUriServ/site/en/oj/2007/l_247/l_24720070921en00210055.pdf

The main concern is the timeline. All EU member states will have to transpose the directive by December 21, 2008 into their national law. The directive then will have transition period until March 21, 2010. (See Article 4)

The update was intended to be a clarification of the current old version and should not have a major economical impact. This was actually stated in one of the proposal documents prepared by the commission. I guess we all had some major interpretation problems in the past. As we know today the directive will impact compliance significantly. Just to name a few aspects:

- classification rules have been updated,
- clinical data requirements have been significantly increased for all products,
- vigilance requirements for manufacturer in reviewing post production clinical data,
- essential requirements (e.g. the need to review for certain products even the machinery ERs),
- audits with detailed technical file reviews for lower risk class products,
- etc.

The new or additional requirements will lead to significant increase of the market surveillance by the national authorities. In the past those above listed aspect sometimes were interpreted when the old directive was applied but the requirements were not written in the law and therefore the authority was not be able to point the finger. With having clear stated requirements in place the authorities will have finally the legal back up to take “appropriate” action. It seems to me that some authorities are waiting for these requirements finally to come.

At the RAPS meeting last month, a representative of the Dutch Authority was presenting in a very disturbing manner. He presented his frustration of the CE marking process and actually substantiated his view with some statistics the Dutch authority collected. He further stated that some of the changes were due to the initiatives by his agency. For example 30 % (+/-) of all technical files were not sufficient according to the Dutch authority review. This high number was as well somewhat disturbing to us. Another aspect he pointed out is the missing clinical data. The authority will focus on those aspects with future reviews. He also stated they will actively go against those “fantasy products”. His example was CE marked magnets which will heal cancer. I wondered why they would not have been able to go against those manufacturers before, but I guess I have to admit that I do not fully understand the restriction of the old directive to put those charlatans in jail.

Now, the directive comes into force in 2010. Do you have to comply now? Strictly speaking, NO, but one day after the enforcement deadline in 2010, manufacturers will have to fully comply. Therefore, our recommendation is to start to look at the directive immediately to check what will be involved for your company to update the compliance of the products.

Let us work with examples:
Some products will fall under a new classification. In case of the reclassification from risk class I to a higher risk class e.g. IIa a notified body involvement becomes mandatory. The earliest a notified body will be able to examine the quality system and or the product will be after the directive has been transposed in to national law where the notified body is situated. As outlined above the deadline for this transposition to occur is December 21, 2008. Whether the directive will be transposed any day earlier depends highly on the ability of the national member state to update its national law. After the deadline the directive will apply independent of the transposition. I am sure some notified bodies will even offer to do a certification early on even without the legal back up. However, this is just an academic procedural timing problem. We recommend in any case, starting this process to update the compliance of your products if not now, not much later. The reason is that a conformity assessment procedure (Audit and technical file review) may be time consuming. In particular, for a risk class I product manufacturer without a quality system. In case of an update from risk class I to a higher risk class product, the conformity assessment may take up to two years depending on the manufacturer’s ability to implement filly the requirements. Should the deadline of December, 2010 be missed the products can not be placed on the market afterwards.

Today, a manufacturer may get a warning from its notified body regarding missing clinical data in the technical file (a lot of manufacturer indicate in the essential requirements checklist “Not Applicable” concerning this requirement –currently Annex I section 14.) After 2010, the product will have to be deleted from the certificate.

For risk class I manufacturers, I already see the competent authority will simply check the clinical data. Products may be restricted due to the lack of such clinical data. Please note that I am not talking about conducting clinical trials, which may be part of the equation. A literature review, your clinical data and or clinical experience, etc. may suffice.

With such a very strong focus on compliance and possible restrictions in this News and Views, this time I am simply trying to say that this is an important update which should be taken into consideration seriously early on.

Should you have any questions or would like to have any clarification please do not hesitate to contact us.

Ludger Möller
MDSS

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