The European Commission has published today 9 Factsheets related to the MDR and IVDR. The documents present main changes, new requirements, transition timeline and frequent…
Update on received NB Applications by the EC
The European Commission has published the State-of-play on the designation process of Notified Bodies (NBs) under the MDR/IVDR at the date of 9 October 2018.…
Brexit and MDR: UK publishes two notices
Notice of 23 August: MDR, CE marking in “no-deal” scenario (after 29 March 2019) For a time-limited period, UK would continue to recognise the CE Mark…
European Commission has received 28 applications from NBs
The European Commission has published the State-of-play on the designation process of Notified Bodies (NBs) under the MDR/IVDR at the date of 30 June 2018:…
Joint Action on Market Surveillance of MD
The UK Medicines and Healthcare products Regulatory Agency and Chafea, executive agency of the European Commission have signed a Grant Agreement in order to reinforce market surveillance of…
Only 5 NB applied under MDR by mid-February
The European Commission received only five preliminary assessment reports from the “designating authorities” by February 12, 2018. As previously discussed on this blog, the submission of the application…
Implementing MDR: Focus on transition period by COCIR and CAMD
Today, COCIR* issued a Position paper on the implementation of the future Regulation on Medical Devices (MDR). The document addresses the transitional period, while putting…
EU Court decides: Software as MD
On 7 December 2017, the Court of Justice of the European Union rendered a judgment in the case of Syndicat national de l’industrie des technologies médicales…
1st Commission Implementing Regulation published!
After the closing of public consultations, the first Commission Implementing Regulation under MDR and IVDR was published in the Official Journal of the EU. As…
New MDR Implementation Tools available in our E-shop !
The below two documents will help manufacturers better understand the MDR timeline, how to comply with the new legal requirements and provide some useful recommendations.…