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…
Survey by TEAM-NB on applications of Notified Bodies under MDR
As stated in the survey performed by Team-NB*, already 80% of the Team-NB members submitted their application to be designated against the MDR by mid February. Half…
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.…
The Commission publishes NEW list of harmonised standards
The European Commission published an updated list of CEN/ Cenelec harmonised standards in the framework of the implementation of the IVD Directive 98/79/EC. The harmonised standards published for the…
Applications to be designated as NB under MDR/IVDR open from 26 November
6 months after entering into force of the new legislation, the European Commission issued a notice informing of the possibility to submit the application to…
Brexit contingency plan: No-deal scenario
The UK Secretary of State for Health and Social Care sent a letter to all suppliers of medical devices outlining the contingency planning in case…