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
- Inhouse-Workshop: The new MDR with impact check at your site to discuss and plan the concrete effects and measures.
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