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…
NEW documents on UDI endorsed by the MDCG
The Medical Devices Coordination Group (MDCG) endorsed 4 new documents related to UDI. 1. UDI & Software As a standard rule, new UDI-DI should be affixed…
Timeline on future adoption of EC Implementing Acts
The European Commission has today disclosed implementing measures rolling plan under the MDR and IVDR. The document gives a bit more clarity on the timeline for the adoption of…
EU Public Consultations now open: Designation of NB
Today, the European Commission has opened public consultations on the Commission Implementing Regulation on the Codes for the designation of Notified Bodies under MDR and IVDR,…
Introductory guide to MDR/IVDR by the UK regulator
The British MHRA has issued an introductory guide to the MDR and IVDR, which is user-friendly and provides an overview of the main novelties introduced by the regulatory…