Increasing scarcity of notified bodies for medical devices – act now!

08/22/2019 | Dr. Guido Middeler
Middeler

Dr. Guido Middeler
Partner

Medical device manufacturers who used to be able to rely on their notified body may soon find themselves without products. Manufacturers of medical devices composed of substances and combinations of substances that are being reassigned from class I to a higher medical device class are especially hard hit. They need product certification by a notified body for the first time, along with an audit of the quality management system according to EN ISO 13485:2016. But of formerly more than 80 notified bodies in Europe, many are no longer obtaining accreditation according to the MDR, which means they can no longer carry out such conformity assessments. Diapharm can help!

Since numerous notified bodies for medical devices will disappear from the market, as politically intended, or have decided against accreditation according to the MDR, Diapharm has developed some tools for manufacturers and suppliers to help them maintain the marketability of their products. We help prevent harm for products – all the way to assuming overall regulatory responsibility. Recently we once again proved our expertise:

  • Successful re-certification according to ISO 13485:2016 for the development, production and distribution of medical devices
  • Successful re-certification as European Authorised Representative (EAR)
  • Successful initial certification according to the Medical Device Single Audit Program (MDSAP) for the distribution of medical devices in Canada

Contrary to expectations, the path to the Medical Device Regulation is currently still through re-certification according to the “old” MDD. Article 120 of the new MDR allows medical devices to be distributed according to the old and new standards in parallel during a transition period until May of 2024. In view of massive delays with the accreditation of notified bodies, this transition period is currently more important for manufacturers than ever before.

Loss of notified bodies – a foreseeable drama

I have long since warned that there would be bottlenecks in the conformity assessment when the new Medical Device Regulation comes into effect. But even I did not expect things to get this tight: not even half the notified bodies in Europe are currently striving for re-certification according to the MDR. Barely 10 months before the “old” Medical Device Directive loses validity, there are only two (2) [Update 21.08.2019] four (4) notified bodies in all of Europe that are already able to issue certificates based on the new regulation – and one of these is based in the United Kingdom, threatened by Brexit.

To make matters worse, it is not clear to what extent the remaining notified bodies are going to obtain accreditation, especially for the niche market of substance-based medical devices. If they do not, they will no longer be allowed to assess the conformity of these products.

According to the industry association Spectaris however, 27,000 medical technology companies will need new MDR-compliance certificates in the coming years. Hundreds of thousands of products are affected. Massive bottlenecks in the preparation of certificates are therefore inevitable. This problem was already addressed by the industry associations in October of 2018 under the significant title “Bermuda Triangle Notified Bodies” during an MDCG Stakeholder Meeting in Brussels attended by the EU Commission and representatives of the member states. Even if additional notified bodies should obtain accreditation according to the MDR by May of 2020, it must be assumed that the complete execution of MDR-compliant conformity assessment procedures will not be possible by 26 May 2020.

Bottlenecks for medical devices worsened by higher classification

The situation is even more dramatic for medical devices composed of substances and combinations of substances such as tablets or suppositories as well as reusable surgical instruments or, highly relevant, medical apps. This is because the higher classification caused by the MDR, with reassignment from class I to class IIa, IIb or even III, makes a conformity assessment procedure with the involvement of a notified body necessary for the first time. In the situation described above, what are the odds of finding a new notified body that is able to assess these products in the specified time?

All manufacturers of medical devices should therefore urgently enquire with their notified body whether it is even striving for re-accreditation, whether the scope of this accreditation continues to encompass the required products, and whether it is actually able to ensure timely re-certification or initial certification. Diapharm’s notified body is going to meet all of these requirements.

We will therefore continue to be able to conduct conformity assessment procedures for medical devices in the form of substances going forward.

Fast, ongoing help from Diapharm for medical devices

This is exactly where the Diapharm service comes in: manufacturers who are no longer able to rely on their notified body can transfer the regulatory responsibility for their products to Diapharm in part – or even entirely. This not only encompasses the conformity assessment, but all regulatory obligations arising from the Medical Device Regulation, such as:

  • Post-market surveillance according to MDR requirements (starting on 26 May 2020, also required for existing products according to 93/42/EEC)
  • Person responsible for regulatory compliance
  • Quality management according to ISO 13485 (required for all higher classified medical devices)
  • Product risk management
  • Updating the technical documentation in preparation for the MDR
  • Conformity assessment procedures according to the MDR standard
  • Assuming responsibility as the legal manufacturer for products under various brands

We take the fear out of the Medical Device Regulation. Contact us!

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