A harder to get CE mark | Sagentia Innovation

A harder to get CE mark

13 June, 2013

Earlier this year, the European Parliament’s Committee on Environment, Public Health and Food Safety (ENVI) published two draft reports amending the Commission’s proposals for both Medical Devices Regulation and IVD Devices Regulation within the EU. These proposals are now with member states for feedback and the plan is that following this review and any resulting changes, the Regulations will be scheduled for approval by the European Parliament in 2014 with an expected date for them to come into force in 2017. There are many implications from these proposals (which contain almost 1000 amendments!) that will be critical for medical device manufacturers operating in the Eurozone.


The latest proposal covers a wide range of changes including revised approaches for the regulation of reprocessing, stricter controls over Notified Bodies, greater involvement of healthcare practitioners in incident reporting, and a prominent role for the European Database on Medical Devices (Eudamed) etc. At the core, however, the proposal outlines an FDA-style premarket approval (PMA) process which divides medical devices into three categories: “innovative” devices; non-”innovative” but “high risk” devices; and “the rest”. Those classified as “Innovative” would be subject to European Medicines Agency centralized authorization, those classified as non-“innovative” but “high risk” would be subject to decentralized member state authorization, and “the rest” would be subject to the “normal” regime. 

It is often not clear what is innovative and/or risky until we have tried it

You may be wondering why all the quotation marks?… those are the terms that are yet to be clearly defined. At the moment some of these terms are being left to the European Commission to define during the approval process. So, while it is all well and good to put in more amendments and procedures in place, the importance of defining “high risk”, “innovative” and “the rest” should not be overlooked. For example, breast implants and hip implants were originally viewed as low risk and it was only once concerns started being raised that they were upclassified to “high risk” in ~2007 (whether they would have ever been labelled as “innovative” is a separate question). So how would the new proposals address reclassifications?

And how do we reclassify something when the classifications are opaquely defined? As a market, we are reacting to issues by reclassifying devices. This is because it is often not clear what is innovative and/or risky until we have tried it and then we modify the classification to suit. We would encourage the ENVI to take this into account when putting their new proposals into practice. Hindsight is 20-20 but we should try to encourage more clarification of current practice and the present. 


Fiona Haig



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