New: MDR / IVDR

Medical Device Regulations

On 5 April 2017, the European Parliament adopted the new EU medical device regulations. They were published in the Official Journal of the European Union on 5 May 2017 and have been in force since 25 May 2017. Since then the transitional provisions [Article 120 (MDR) and Article 110 (IVDR)]] apply.

They replace the EU directives for medical devices which have been in force for more than 20 years.

Affected are:

  • Active implantable medical devices
  • medical devices
  • in-vitro diagnostics

Here you will find the latest information on the contents of the new MDR / IVDR:

Our service:

We support you with the following services:

Ressources:

The “Medical Device Regulations” published in the Official Journal of the European Union on 5 May 2017:

I wish you a lot of success in preparing for the coming requirements and will be happy to support you!

DI Martin Schmid
CEO & Senior-Consultant
en.co.tec