The MDCG released on 1st of July 2019 a Guidance on the Implant Card (IC) disciplined by MDR Article 18 and on information to be…
MDCG releases guidance on Person Responsible for Regulatory Compliance
On July 1st 2019, a MDCG guidance has been published to better clarify the role of PRRC. The main clarifications focused on qualification of the…
Draft EMA Guideline + MDCG Guidance to be endorsed
EMA (European Medicines Agency) has opened public consultations on the draft Guideline for drug-device combination products that will close on the 31st of August 2019.…
UDI issuing entities: first names revealed
The European Commission was mandated and released a draft Commission implementation Decision together with the Annex listing the following four issuing entities designated to operate…
MDCG Q&A for Notified Bodies
The MDCG has just published useful Questions & Answers document, especially relevant for the Notified Bodies. It focuses on the Notified Bodies’ requirements under MDR…
New expert group under MDR
A new expert subgroup of the MDCG was established to cover Annex XVI products; therefore issues with products without an intended medical purpose but falling…
Clinical Evaluation Report: New MDR implementation tool
The results of clinical evaluation and clinical evidence on which it is based shall be documented in a clinical evaluation report (CER), which shall support…
MDCG Guidance on Basic UDI-DI
Updated guidance was just published by the MDCG to better clarify the notion of Basic UDI-DI, its usage and when a UDI-DI requires changes. The…
Official MDR & IVDR Corrigendum published!
On May 3rd 2019, the Corrigendum of both Regulations was published in the Official Journal of the European Union. MDR Corrigendum IVDR Corrigendum Apart from…
MDCG on registration of ”legacy” devices
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…