BSI supports its clients with their own FAQ

We are pleased to announce that the highly anticipated Q&A clarifying several aspects regarding the latest extension (Regulation (EU)2023/607) has been published.
We would also like to thank our clients for their valuable feedback, which greatly contributed to the success of last week's MDSS Seminar. During the seminar, we covered a number of important aspects, with the most pressing question being - when can products can be sold again??? This topic has been addressed in Question 7 of the Q&A: “The extension of the transitional period and the concomitant extension of the certificate’s validity is done automatically by law, …” (subject to certain conditions).

Another important question raised during the seminar was - how to demonstrate the validity of an expired Certificate??? In response to this, Question 7 offers several options:

• Self Declaration based on a harmonized Template; 
  • MDSS comment: It would be beneficial if the Commission could publish this template. Alternatively, one could seek help from prominent trade associations in the EU who may have a proposal.
• Confirmation letter issued by the NB acknowledging the receipt of the application and confirming the written agreement is in place, without incurring any extra cost;
  • MDSS comment: The NBs work together on such a letter. However, this letter may not cover all the conditions. The NBs have not received the task to check and confirm that conditions are met due to their constraints in resources.
• The CA should be able to issue Free Sales Certificates;  
  • MDSS comment: This could potentially be the most effective approach. The CA would likely conduct checks to ensure that the conditions are met, rather than solely relying on self-declaration
• The Commission will update its factsheets for CA outside the EU;
  • MDSS comment: This could support the manufacturer, however, a third country may still wish to verify that the conditions are met.

We are also excited to inform you that we are working on a one-step approach that will enable the Authorized Representative to support the manufacturer with a single document indicating that all necessary conditions have been checked and confirmed. This will provide our clients with a much-needed solution and will be available in the near future.

BSI has issued their own FAQ, which focuses on the involvement of the NB. They have confirmed that they are working with other NBs on a harmonized letter and have advised those who switched back  or consider to switch back to the BSI normal service, due to the extension, that they will find themselves back in line. 

We remain committed to supporting our clients and will continue to provide updates as they become available. 

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The regulation (EU) 2022/2346, released on 1 December 2022, lays down common specifications for the groups of products without an intended medical purpose listed in Annex XVI to Regulation (EU) 2017/745.

The transitional provision are explained in Article 2 and 3. Some provisions will enter into force on 22 December 2022. Here you can find the whole document.

The provisions in this document may provide a taste for the new transition of all other legacy products discussed here last week. If we apply this, then certificates may safely expire, however, a Notified Body will need to be engaged for surveillance activities. This can be your current MDD Notified Body or your new MDR Notified Body. 

Can this be even more complicated?? In any case, we are just curious about the cut-off date. 

An early date would be good for many manufacturers, however, it may already be too late for some other manufactures who stopped their products and disengaged from a Notified Body.   

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Deadline/transition - further info!

What else happened last Friday, next to the proposed extension of the MDR Deadline for legacy products (see our Newsletter from Monday)?  

The MDCG 2022-18, a very special guidance, was published, intended to guide in particular authorities, to help manufacturer to bridge to the MDR. This is needed since the deadline extension will most likely have a cut-off date. 

The MDCG 2022-18 clarifies and tries to harmonize Article 97 on “Other non-compliance”.

What is clarified:

• A missing certificate is just a non-compliance!
• The allowance from one CA to market the products is valid for the whole EU.
• Free Sales certificates may be issued.

What is harmonized:

• Member states should apply the process and accept documents in a similar manner
• Member states agree on a standard communication

Some of the rules, in particular the limitation to one year or to SMEs, cannot be found in the MDR. In any case, it may be wise, if not existential, for companies to go this route and if indeed the device is safe and this can be demonstrated objectively, then a member states may not have a choice but to allow the marketing of the products.

MDSS has already successfully supported several clients in navigating them through these complex procedures and enabling them to market the products despite facing the expiration of the MDD certificate and not being MDR certified yet. 

We are looking forward to supporting all our clients as EC REP!

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Is Europe preventing the Chaos and getting back to Order with this extension proposal?

The outcome of last Friday's, December 9, 2022, EPSCO meeting was that, indeed, the transition period of legacy products is going to be extended!

• Until 2027 for risk class IIb and III
• Until 2028 for risk class IIa and class I up-classified

Additionally, there was the removal of the sell-off period. However, this might not help Manufacturers located outside the EU, since the Importer is the one placing the product on the market. Further clarifications may be needed from the Commission.

Among others, the extension was announced in this paper. The member states had a chance to express their views on the topic and there was, in fact, great support. If you are interested, you can watch here EU law making in progress. 

The details still need to be provided and the proposal must go through the legal process before implementation.

Unfortunately, details are yet to follow and the big question to be answered now is: from which date are legacy products being included? It could be that certificates which have expired are as well honored. However, there might be a cut-off date which does not include your certificate.

Therefore, the outline is to follow Article 97!

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