Europe – GMED : Evaluation Biologique des Dispositifs Médicaux selon la Norme ISO 10993-1
Ce guide est applicable à tous les dispositifs médicaux, quels que soient leur classe et leur type.
Afin de mener à bien une évaluation biologique...
UK – Brexit Readiness Checklist for companies doing business with the UK
The United Kingdom’s choice to cease to participate in the EU’s Single Market and Customs Union and put an end to the free movement...
Europe – Un 17ème Organisme notifié habilité au titre du RDM (3EC International SLOVAKIA)
Un 17ème Organisme notifié habilité au titre du RDM (3EC International SLOVAKIA)...
Europe – MDR/IVDR update: Experts share what keeps them up at night
Speaking virtually at RAPS Convergence on Monday, top European medical device and in vitro diagnostic (IVD) experts shared what keeps them up at night as...
Europe – Evaluation clinique : Guide du GMED
La confirmation de la conformité aux exigences générales pertinentes en matière de sécurité et de performances applicables du règlement (UE) 2017/745, dans des conditions...
Europe – Interprétation de l’évaluation clinique : orientations de la CE à l’intention des...
Le présent document a pour objectif de fournir des orientations de la Commission aux groupes d’experts établis en vertu de l’article 106 du règlement...
UK – Regulating medical devices from 1 January 2021
From 1 January 2021 the Medicines and Healthcare products Regulatory Agency (MHRA) will take on the responsibilities for the UK medical devices market that...
UK – MHRA posts suite of post-transition guidances
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) on Tuesday released more than two dozen guidance documents explaining how drugs, medical devices, clinical...
Europe – European Commission sets common specifications for reprocessing single-use devices
The European Commission this week issued regulations establishing common specifications for the reprocessing of single-use medical devices under the Medical Device Regulation (MDR).
Under MDR, single-use devices...
Europe – MDCG 2020-15 : Position Paper on the use of the EUDAMED actor...
Article 33 of Medical Devices Regulation (EU) 2017/745 of the European Parliament and of
the Council of 5 April 2017 (hereafter: ‘MDR’) sets out that...
