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Proposal for amending the medical devices transition - feedback open!

Commission proposal for a Regulation of the European Parliament and of the Council amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards the transitional provisions for certain medical devices and in vitro diagnostic medical devices is open for feedback until January 18, 2023. All feedback received will be summarised by the Commission and presented to the Parliament and Council with the aim of feeding into the legislative debate. 

MDSS' already submitted feedback and our proposal would allow all legacy products to enter the MDR process immediatelySee here our feedback and give your own opinion to the Commission here.

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Categories: News

Proposal for amending the medical devices transition extension was published! 

The proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards the transitional provisions for certain medical devices and in vitro diagnostic medical devices was adopted on January 6, 2023 by the Commission. The Parliament and the Council will now have to adopt the proposal via an accelerated co-decision procedure. 

See here the official press released and here the proposal.

Key elements of the proposal according to the Commission press release:

  • For medical devices covered by a certificate or a declaration of conformity issued before 26 May 2021, the transition period to the new rules is extended from 26 May 2024 to 31 December 2027 for higher risk devices and until 31 December 2028 for medium and lower risk devices. The extension will be subject to certain conditions, so that only devices that are safe and for which manufacturers have already taken steps to transition to the rules provided for by the Medical Devices Regulation will benefit from the additional time.
  • The proposal introduces a transition period until 26 May 2026 also for class III implantable custom-made devices, giving their manufacturers more time to obtain certification by a notified body. Also in this case, the transition period is subject to the application of the manufacturer for a conformity assessment of devices of this type before 26 May 2024.
  • To reflect the transition periods put forward by these amendments, the proposal extends the validity of certificates issued up until 26 May 2021, the day when the Medical Devices Regulation became applicable.
  • The Commission also proposes to remove the ‘sell-off' date currently established in the Medical Devices Regulation and in the In Vitro Diagnostic Medical Devices Regulation. The ‘sell-off' date is the end date after which devices that have already been placed on the market, and remain available for purchase, should be withdrawn. Removing this ‘sell-off' date will ensure that safe and essential medical devices that are already on the market remain available to healthcare systems and to patients in need.

For the next steps, the proposal still has to go through the legislative procedure to be adopted as law!

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Categories: News

Products without an intended medical purpose!

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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Categories: News

EU MDR BRIDGE

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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Categories: News

EU MDR deadline/transition!

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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Categories: News
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