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Official Q&A on the extension of the MDR published!

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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Categories: News

Have your say!

EU proposes Master UDI for contact lenses

The European Union has introduced a new initiative for a Master Unique Device  Identification (UDI) Device Identifier (DI) (Master UDI-DI) for highly individualized contact lenses. The UDI system is designed to improve traceability and accountability for medical devices, including contact lenses. This proposal is product-specific and seeks to streamline the registration process for manufacturers and improve patient safety. Feedback on the proposed Master UDI-DI may be provided  until April 19th. 

The proposed Master UDI-DI for highly individualized contact lenses is a significant step forward in medical device regulation. Under this initiative, not every individual lens would be assigned a UDI-DI.  Lenses will be grouped with a Master UDI-DI. “Master UDI-DI is intended as the identifier of a group of highly individualized devices (i.e. contact lenses) presenting specific similarities with respect to defined clinically relevant Parameters”.

While this initiative is specific to contact lenses, it raises questions about the potential for a Master UDI-DI for other highly individualized medical devices. The European Commission has already received comments on this initiative, and if your products fall under a similar category, it may be worth considering commenting on the proposed Master UDI-DI.

 As with any new regulation, it is essential to stay informed and up-to-date. Delegated acts can be found on the Commission websiteBefore assigning a UDI and registering your product in Eudamed, it is recommended that you check whether there are any Master UDI-DI requirements for similar products. 

Don't miss the opportunity to provide feedback on this proposed regulation. Comments are open until April 19th, so be sure to have your say on this important matter!

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New Features and Improvements in EUDAMED Production v 2.10

EUDAMED Production v 2.10 has been released with several new features and improvements.

Are you ready for the latest and greatest version of EUDAMED Production? Look no further than version 2.10, which comes with a range of exciting new features and improvements. In this post, we'll provide you with a brief overview of what's new, including updates to the Actors module, UDI/Device module, NB & Certificates module, and DTX.

One of the key features in the Actors module is the ability to set an Economic Operator as inactive, which creates a new version of the Economic Operator with the new status. The UDI/Device module now allows you to search for devices by indicating the Competent Authority (CA) responsible for the manufacturer, while the NB & Certificates module lets you register refused certificates, refused applications, and withdrawn applications of type product.

In addition to these exciting new features, EUDAMED Production v 2.10 also includes several user experience and user interface improvements, various fixes, and updates to the DTX. So if you want to operate more efficiently in EUDAMED, be sure to upgrade to the latest version today. Read the full document here.

For more news and updates from the medical device industry, be sure to check out MDSS News & Views.

Categories: News

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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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 MDR Article 120.3, 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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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


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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