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…
MDCG Working Groups: Tasks, Membership, Meetings
The Terms of reference of the following MDCG Working Groups were recently published: MDCG Working Group 1: Notified Bodies Oversight (NBO) MDCG Working Group 2:…
The EC requests guidelines on phthalates in certain medical devices
The European Commission has requested the Scientific committee* to provide guidelines on the benefit risk-assessment of certain phthalates present in the medical devices that: • are invasive…