The second document related to EUDAMED was published today on the European Commission website. The MDCG discussed registration of a ”legacy” device, i.e. device with…
New MDlaw Checklist: Crucial tool to show compliance with Annex I MDR
New GSPR Checklist, now available in our MDlaw e-shop was carefully prepared by our experts to help you comply with the General Safety and Performance…
MDCG: When pre-market consultation of expert panel is not required
MDCG (Medical Devices Coordination Group) endorsed a Document, where it further explains the Article 54(2)b that was so far subject to different interpretations. Second paragraph…
New Team-NB Survey on NB capacities
Find below the replies from 22 (out of 24) NB members in the most recent study organized by the Team-NB concerning the 2018 and wished…
EMA Q&A on Article 117 of MDR: Medicines with medical device component
Last Friday, European Medicines Agency (EMA) published first guidance on the implementation of the Article 117 of the Medical Devices Regulation (MDR) that requires intervention…
CND nomenclature selected for the future EUDAMED!
Under Article 26 of the MDR, the European Commission was tasked to make available an internationally recognised medical devices nomenclature that will be free of…
European Commission update on the MDR implementation
Today, at a conference in Brussels, the European Commission shared important points and dates regarding the MDR implementation and preparedness of the regulatory framework, and…
Combination products: MDCG provides guidance on UDI-related obligations
The MDCG endorsed a new guidance on the UDI-related obligations when it comes to medical devices that administer/incorporate medicinal substances, human tissues and cells as…
MDCG Position on Content of the certificates, voluntary certificate transfers just published!
The MDCG endorsed a Position document – Guidance on content of the certificates, voluntary certificate transfers where it discussed: Content of the certificate under MDR…
NBs on Classification Rule 8 of the MDR
NB-Med and Team-NB issued a Joint Position Paper to ensure more harmonized classification of implantable devices and long-term surgically invasive devices under the new MDR…