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.
- Active implantable medical devices
- medical devices
- in-vitro diagnostics
Here you will find the latest information on the contents of the new MDR / IVDR:
- Expert presentations at MDR / IVDR from the “Business Treff” – 7.11.2017
- The new EU medical device regulations: Changes and open questions – 25.9.2017
- New Medical Devices Ordinance: Obligations of the retailer – 4.7.2017
- MDR / IVDR published in the Official Journal of the European Union – 5.5.2017
- EU Parliament approves Medical Devices Regulation- 5.4.2017
- New EU regulations – publication is approaching – 27.3.2017
- MDR – The most important innovations at a glance – 23.3.2017
- The new EU regulations overcome the next hurdle – 9.3.2017
We support you with the following services:
- en.co.tec Regulatory Kick-Start: Clarify individual questions about the new In Vitro Diagnostics Regulation or Medical Devices Regulation.
- en.co.tec Regulatory MedTech-Newsletter
- XING-Gruppe: Regulatory News MEDTECH
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