Regulatory Affairs

CE Marking: MDR & IVDR

In 2021, after a four year transition period, the European Medical Device Regulation (EU) 2017/745 (MDR) was finally put into effect, and replaced the Medical Device Directive (MDD) and Active implantable Medical Device Directive (AIMDD).

The requirements for the conformity assessment procedure of in vitro diagnostic devices are now laid out in the separate IVDR (EU) 2017/746.

MDR – a never-ending story

European and national authorities offer little support in implementing the increased requirements. The EUDAMED system is still not fully operational and the Notified Body certification process is far from being completed. On the contrary, it will still take several years before sufficient Notified Bodies are available. The same applies to the notification of Notified Bodies for the IVDR. Here the situation is quite worse and more manufacturers of IVD products will need a Notified Body.

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European Union and yet no unity?

Even with the introduction of the MDR and IVDR, national requirements continue to be established that differ from country to country. For example: by affixing the CE marking, you can theoretically sell your Medical Device throughout Europe. But is the German and English instruction for use sufficient for this, or is a translation for each European country necessary?

Further possible obstacles in Europe are:

  • Special cases like Switzerland or the United Kingdom
  • Changing circumstances due to COVID-19
  • Common Specifications defined by the European Commission
  • Notified Bodies that are uncertain in the accuracy of their interpretation of requirements

One new regulation – Many challenges

While many manufacturers are still busy trying to understand the new MDR requirements and implementing the necessary changes in their processes, new MDCG documents are constantly appearing. It is not clear when there will be a complete set of harmonized standards or whether their own Notified Body will be able to recertify under the MDR in time for the certificates to expire.

For many laboratories, the new requirements on "in-house IVDs" in the IVDR will mean that they will have to change their range of services.

This is a difficult time that requires keeping up to date with the latest opinions, statements and guidance documents from the Commission or the EMA, for example, while at the same time planning transition projects within the company.

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