Please be aware that there were new/updated forms published on the Commission website with regard to incident reporting: Manufacturer incident report 2020 (Form) Manufacturer incident…
New NB under the MDR!
This morning, a Swedish notified body joined the NANDO database of certification bodies accredited under the MDR. Intertek Medical Notified Body AB Torshamnsgatan 43, Box…
Clinical investigations under the MDR: MDCG on Safety reporting
The Medical Devices Coordination Group (MDCG) has published a guidance document on Safety reporting in the context of clinical investigations. According to Article 80(2) and…
Planning of MDCG guidance documents updated
You will find below the updated document on the ongoing work of the MDCG and its subgroups. Majority of guidance documents has the deadline foreseen…
New MDR NB designation + MDCG addressing COVID-19 outbreak
NANDO is richer for a new MDR accredited Notified Body, which brings us to 13 certification bodies designated under the new Regulation: MDC MEDICAL DEVICE…
MDCG: PMCF Templates, Equivalence, Clinical evidence for legacy devices
The European Commission also released this morning 4 important MDCG documents covering PMCF, namely template for a Plan and Report and guide on equivalence and…
MDR delay is official – new Regulation published in the Official Journal!
Regulation (EU) 2020/561 of the European Parliament and of the Council of 23 April 2020 amending Regulation (EU) 2017/745 on medical devices, as regards the…
MDR delay approved also by the Council!
The Council of the EU agreed to the position of the European Parliament in a written procedure and adopted the REGULATION OF THE EUROPEAN PARLIAMENT…
European Parliament approves to move forward with MDR delay Proposal
In the final vote announced today at 16h, the European Parliament approved to move forward with the Proposal to delay the MDR (Regulation 2017/745 on…
Council gives green light to launch negotiations on MDR delay + MDCG Guidance on NB audits during COVID-19
The Council of the European Union agreed today to a Mandate for launch of negotiations with the European Parliament to delay MDR under urgent procedure.…