MDR: CLARIFICATION on the implications of the MDCG 2022-18 and Dec 6th EPSCO meeting

The EU Commission proposal to extend the transition period of the EU MDR 2017/745. ?At same moment was released the MDCG 2022-18 on Article 97 used to continue placing devices on the market.

This has led to a lot of confusion and a lot of “ Wishful Thinking”.

I don’t want to be a kill joy, however, I want you to clearly understand the implications of these documents in order to be best prepared ?and hopefully be able to continue to have your legacy device on the EU market.

EPSCO meeting- Commission Briefing NOTE

THIS IS ONLY A PROPOSAL- It is not yet a done deal. ?

In this note, that is NOT THE LAW, there are a lot of TENTATIVE options outlined that COULD potentially be included in the final proposal. ?Currently, this note does not define any clear mechanism. They are so many situations that will need clarification.

They are however two concrete important points:

-?????You need to have undertaken the necessary steps to launch a certification process under the MDR. It is not clearly mentioned what will be demanded, however, one can expect that you will need to have your APPLICATION FOR CONFORMTIY assessment ACCEPTED by a NB.

Just having a plan scheduled with your NB will probably not be sufficient.

-?????The removal of the “sell off” provision in article 120(4) MDR and 110(4) IVDR. For MDR, currently the legal deadline is May 27th 2025. If this concrete proposition is approved, then no pressure to get all your stoke out to clients.

The other suggestions have no clear mechanism on how they will be implemented or even clear cut dates. Only a suggestion on the year:

-?????2027 for Class III and IIb implantable

-?????2028 for Class I and IIa.

The Medtech community if waiting to see the Art97(3) implementing measure to be harmonized on the European level. It seems however, that what will be released in a MDCG position paper. The reason behind might be to release the European commission for any responsibility of the harmonization process (that can take a long time). It also has the “advantage” of flexibility for member states. This advantage of course is more of a disadvantage for the industry.

MDCG 2022-22- Position paper on the application of Art 97 MDR

First thing that is very important to clarify. This is not an EXTENSION of the transition period. It is only a “breach” in the legal frame work that was found to find a solution to help avoid the ?crisis Europe is headed to.

Article 97 AKA as Article “OTHER NON-COMPLIANCE”

Item (3) reads: “ In order to ensure the uniform application of this Article, the Commission may, by means of implementing acts, specify appropriate measures to be taken by competent authorities to address given types of non-compliance. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 114(3).”

Therefore a solution is found for a NON COMPLIANT device (to MDR) to be sold on the EU market.?This is to be a TEMPORARY solution.

Important points to keep in mind are the following:

-?????This procedure is DEVICE based.

Therefore, if you have several devices, you will need the same amount of submission to the CA.

-?????This ?MDCG applies to devices for which despite reasonable efforts undertaken by the manufacturer, the relevant conformity assessment procedure involving a NB has not been concluded in time. This means, it is you will probably need to have your APPLICATION FOR CONFORMTIY assessment ACCEPTED by a NB.

Based on past experienced, it seems that having a road map with a NB is not sufficient. You really need to have your NB approve your MDR application to show that you are ready. ?

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-?????TIME FRAMES: You will need to submit to the CA of the country you are registered or your AR is registered: Therefore countries with a large number of MD industry or AR will be drowned in a Tsunami of requests. Will these NB have the manpower to deal with all these request that are PER DEVICE? Prior to this MDCG timeframes were already of several weeks to months depending on the CA. With the release ?of this mdcg, it is foreseeable that the CA will be flooded by demands.

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-?????In the ANNEX of the MDCG ?a list of the documents to be submitted in clearly presented. This is progress as prior to the publication each CA had their own wish list. It is important to emphasize that the list of information/documentation requested can be challenging and time consuming to collect and prepare. And don’t forget you need this for each of your devices.

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?Don’t hesitate to contact our team of SMEs if you have any questions

Sources:

·???????EPSCO Meeting article:?https://medicaldeviceslegal.com/2022/12/11/the-epsco-meeting-and-beyond/

·???????Commission briefing note on EPSCO meeting:?https://data.consilium.europa.eu/doc/document/ST-15520-2022-INIT/en/pdf

·???????MDCG 2022-18:?https://health.ec.europa.eu/system/files/2022-12/mdcg_2022-18_en.pdf

#MDCG #mdr #cemarking #cemark #Art97 #EPSCO #EU #eucommission

#extension