EU MDR/IVDR
The Medical Device Coordination Group (MDCG), an advisory body of the European Commission focused on the improvement of the regulatory framework in the sphere of medical devices, issued guidance dedicated to the safety reporting in clinical investigations under the...
EU MDR/IVDR
The European Commission (EC), the EU body focused on the improvement and development of medical devices regulation, issued guidelines describing the way the EU-wide derogations for medical devices should be applied under the Medical Devices Regulation 2017/745 (MDR)....
EU MDR/IVDR
The European Commission (EC), the EU body responsible for medical devices regulatory framework, announces amendments to the designation procedures related to the Notified Bodies (NBs), and also to the rules on the EU-wide derogations. EC New Regulations in Brief Both...
The Council of the European propose to amend the dates of application of certain provisions of the Medical Devices Regulation 2017/745 (MDR) superseding the Medical Devices Directive 93/42/EEC and the Active Implantable Medical Devices Regulation 90/385/EEC in...
The Medical Device Coordination Group (MDCG), the advisory body of the European Commission composed of representatives of all member states, issued a guidance document dedicated to the Implant Card (IC) to advise the industry representatives on the application of the...
EU MDR/IVDR
The Medical Device Coordination Group (MDCG), an advisory body of the European Commission composed of representatives of all the EU Member States, issued guidance dedicated to the Unique Device Identification (UDI) system implemented by the Medical Device Regulation...
