International Medical Device Regulators Forum (IMDRF) is a group of regulators specialising in the field of medical devices. The IMDRF aims to move forward with…
UK recognises extended CE Certificates
The UK is taking new steps to recognise the extended CE Certificates in light of the recent amendment of the MDR and IVDR transitional periods.…
Q&A on extension of the MDR transitional period and removal of the “sell off” period
Following the publication of the latest amendment to the Medical Devices Regulations (MDR and IVDR), the European Commission published a Q&A document to facilitate the…
MDR: 38th Notified Body on NANDO!
The NANDO database has a new Notified Body under the MDR! SZUTEST Konformitätsbewertungsstelle GmbH is the 38th EU Notified Body under the Regulation (EU) 2017/745…
Amendment to the MDR and IVDR transitional period is official!
Today, 20 March 2023, the Official Journal of the European Union published the latest amendment to the Medical Devices Regulations (MDR and IVDR). After the…
New Timeline for MDCG Guidance Documents for 2023
The European Commission Directorate-General for Health and Food Safety has released the updated document on the ongoing work of the MDCG and its subgroups. You…
The Council accepts Proposal for extension of legacy period
On March 7, 2023, the Council of the European Union voted in favour of the new transitional provisions for certain medical devices and in vitro diagnostic…
European Parliament accepts Proposal for extension of legacy period
On February 16, 2023, the European Parliament voted in favour of the Proposal to prolong the transitional provisions for certain medical devices and in vitro…
MDCG Q&A on MDR vigilance terms and concepts
The Medical Devices Coordination Group (MDCG) has issued new guidance clarifying important terms and concepts on vigilance stated in the Medical Devices Regulation (MDR) 2017/745.…
Conformity assessment: Annual report on Clinical Evaluation Consultation Procedures (CECP)
According to Article 54 of the Medical Devices Regulation (MDR), Notified Bodies have to follow a Clinical Evaluation Consultation Procedure (CECP) when performing a conformity…