Theme Legacy devices Target Audience Manufacturers, Notified bodies Products concerned MD Regulatory reference MDR (EU) 2017/745 Documents mentioned MDCG 2020-3 MDCG 2021-25 This position paper concerns legacy medical devices, i.e. devices with an MDD or AIMDD...
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MDCG 2022-17 : MDCG position paper on ‘hybrid audits’– December 2022
Theme Hybrid audits Target Audience Notified bodies, Manufacturers Products concerned MD/IVD Regulatory reference MDR (EU) 2017/745IVDR (EU) 2017/746 Documents mentioned MDCG 2020-4 MDCG 2020-17 MDCG 2022-14 This MDCG document clarifies the definitions and...
Switzerland – non-renewal of the Mutual Recognition Agreement with the EU: adjustments or real upheaval?
Switzerland non-renewal of the Mutual Recognition Agreement with the EU: adjustments or real upheaval?Switzerland - non-renewal of the Mutual Recognition Agreement with the EU: adjustments or real upheaval?Since 2002, a Mutual Recognition Agreement (MRA) has linked...
MDCG 2022-16 : Guidance on Authorised Representatives Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) – October 2022
Theme Authorised representatives’ obligations Target Audience Authorised representatives, Manufacturers and other economic operators Products concerned MD/IVD Regulatory reference MDR (EU) 2017/745IVDR (EU) 2017/746 Documents mentioned MDCG 2019-7MDCG 2019-13MDCG...
MDCG 2022-15 : Guidance on appropriate surveillance regarding the transitional provisions under Article 110 of the IVDR with regard to devices covered by certificates according to the IVDD – Septembre 2022
Theme Transitional provisions Target Audience Notified Bodies (NB) Products concerned IVD Regulatory reference IVDR (EU) 2017/746Article 110 Documents mentioned MDCG 2022-4MDCG 2022-6MDCG 2022-8MDCG 2019-10 rev.1MDCG 2022-12CAMD MDR/IVDR Transition subgroup : FAQ –...
Cécile Reynès
Graduated of a PhD in Vascular Physiology carried out in a research laboratory and in an electro-medical devices company, the aim was to demonstrate a new therapeutic indication of a class IIa device in the management of pain in diabetic patients with peripheral...
MDCG 2022-14 : Transition to the MDR and IVDR – Notified body capacity and availability of medical devices and IVDs – August 2022
Theme Transition to the MDR and IVDR Target Audience Notified Bodies (NB), Manufacturers Products concerned MD & IVD Documents mentioned Regulation (EU) 2017/745 Regulation (EU) 2017/746 MDCG 2019-6 MDCG 2020-12 MDCG 2022-4 MDCG 2022-11 This document,...
MDCG 2022-13 Rev.1 : Designation, re-assessment and notification of conformity assessment bodies and notified bodies – August 2022
Theme Designation of notified bodies Target Audience Notified Bodies, Designating Authorities (authorities responsible for notified bodies), Joint Assessment Teams Products concerned MD & IVD Documents mentioned Regulation (EU) 2017/745 Regulation (EU)...
MDCG 2022-12 : Guidance on harmonised administrative practices and alternative technical solutions until Eudamed is fully functional (for Regulation (EU) 2017/746 on in vitro diagnostic medical devices) – Juillet 2022
Theme EUDAMED Target Audience Economic operators, Notified Bodies, Sponsors, Member States, European Commission Products concerned IVDs Documents mentioned Regulation (EU) 2017/746 Art. 113 (3) (f) This document presents in table form each article of Regulation...
MDCG 2022-11 Rev.1 : MDCG Position Paper Notice to manufacturers to ensure timely compliance with MDR requirements – June 2022
Theme Compliance with MD Regulation Target Audience Manufacturers Products concerned MD Documents mentioned Regulation (EU) 2017/745 This position paper of the MDCG gives a numerical overview of the state of play regarding applications for conformity assessment...
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