The NANDO database has a new Notified Body under the MDR! SZUTEST Konformitätsbewertungsstelle GmbH is…
MDCG Q&A on MDR vigilance terms and concepts
The Medical Devices Coordination Group (MDCG) has issued new guidance clarifying important terms and concepts…
MDR: 37th Notified Body on NANDO!
The NANDO database has a new Notified Body under the MDR! SLG PRÜF UND ZERTIFIZIERUNGS…
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…
MDR & IVDR national implementation: Austria
The Austrian Medical Device Act 2021 implements the EU Regulations on medical devices and in…
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…