Regulatory Affairs
MDR and IVDR: Medical Device Certification in Europe
April showers bring May flowers: The European Medical Device Regulation (EU) 2017/745 (MDR) is finally here, replacing the Medical Device Directive (MDD) and Active Implantable Medical Device Directive (AIMDD) after a four-year transition period.
The requirements for the conformity assessment procedure of in vitro diagnostic devices are now laid out in the separate IVDR (EU) 2017/746 regulation.
Time to bite the bullet
Because the MDR requirements came into force back in may of 2017, one may expect manufacturers to have prepared for the significantly increased requirements for the Clinical Evaluation Post-Market Surveillance. Unfortunately, this is not the case for most manufacturers. The manufacturers are seemingly surprised with high requirements and high personnel costs.
MDR - a never-ending story?
The European and national authorities also offer little support in implementing the increased requirements. The EUDAMED system is still not fully operational and the Notified Bodies certification process is far from being completed. On the contrary, it will take several more years before sufficient Notified Bodies are available. The same applies to the accreditation of Notified Bodies for the IVDR. Here the situation is quite worse and more manufacturers of IVD products will need a Notified Body.
A major change in the approval process
Many manufacturers benefit from the transitional provisions described in Article 120 of Regulation (EU) 2017/745. But what is to be understood as „substantial changes“ to a Medical Device? Even though this question has already been addressed in an MDCG document, every manufacturer of Class III and implantable Medical Devices are required to confirm with their notified body. We do not consider this to be the most efficient way to conserve resources.
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 user documentation 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.
qtec as your partner
We will guide you through the complex requirements in individual European countries, with the implementation of the EU MDR. With issues pertaining to disagreements or conflicts with your notified body, we are also eager to help.
Our specialists are always up to date, know the most recent requirements, and can implement these requirements focused and compliant to your needs. Whether generic questions or specific topics like biocompatibility and UDI, our team has the answer.
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