The MDCG issued a Guidance on the conformity assessment procedure for special category of devices as per the Article 52 of the MDR: ‘‘for devices…
Updated EC Implementation Rolling Plan (MDR/IVDR)
The European Commission released an updated Implementation Rolling Plan under the Regulations 2017/745 and 2017/746 with the list of implementing acts/actions to take with different…
COVID-19: MDCG on NB designation renewals + surveillance
Following the Commission Implementing Regulation published last week, the MDCG published a guidance this morning to layout common criteria for the renewal of Notified Body…
Commission Implementing Regulation on NB designations + Commission Communication on Union-wide derogations
Our Library of Documents is richer for two more documents addressing the COVID-19 pandemic: Commission Implementing Regulation: renewal of designations and the surveillance and monitoring…
Manufacturer Incident Report + MDR consolidated version
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…