The NANDO database has a new Notified Body under the MDR! SLG PRÜF UND ZERTIFIZIERUNGS…
How MDCG 2022-18 applies in Switzerland: certification gaps and notification
Following the Council’s agreement on the new measures to implement the Medical Devices Regulation (MDR),…
MDCG Guidance on Article 5 (5) of MDR & IVDR!
The Medical Devices Coordination Group (MDCG) has issued a guidance on Article 5(5) of the…
Legacy devices: European Commission adopts proposal to extend Transitional period & Certificates!
The European Commission has adopted a new proposal to give more time to certify medical…
MDR & IVDR: Update to Manual on borderline classification!
The Medical Devices Coordination Group (MDCG) released in December 2022 a new update to their…
Annex XVI devices: Common specifications and reclassification
The official journal of the European Union now includes two Commission Implementing Regulations on Annex…
MDR: 35 Notified Bodies on NANDO
The NANDO database newly listed 35 Notified Bodies under the MDR! INSTITUT PRO TESTOVÁNI A…
Clinical investigations under the MDR: New Revision of MDCG on Safety reporting
The Medical Devices Coordination Group (MDCG) released on October 2022 a new revision to their MDCG…
Medical Devices in the UK: extension for CE marked devices
With Brexit, the legislation of the European Union does not apply in the United Kingdom…
Notified Bodies: requirements, certifications, and applications
Several publications related to notified bodies marked October 2022. Among others, the Medical Device Coordination…