The European Commission released an updated overview of the Notified Body accreditation process under the EU MDR and IVDR. As of 13 of July 2020,…
How many MDR/IVDR Notified Bodies we have by June 2020?
Approaching second half of 2020, NANDO database currently lists 14 Notified Bodies accredited under the MDR with updates to listing of BSI Group The Netherlands…
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…
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…
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.…
Planning of MDCG meetings updated
You can see below the MDCG and subgroups meetings, as foreseen for the next 6 months. Next meeting of the MDCG is only planned for…
Notified Body designations: Updated State of play
The European Commission released the updated State of play on the designation process of the Notified Bodies under the MDR and IVDR. As it is…
More MDCG guidance released!
The MDCG endorsed two new documents, which brings us to three MDCG guidance’s in the past day! 2020-01 Guidance on Clinical Evaluation (MDR) / Performance…
We have the 10th NB under the MDR!
This morning, the European Commission updated the NANDO website and announced the designation of another Notified Body (NB) under the MDR – (EU) 2017/745: DNV…
Risk Management
In view of the recently published ISO 14791:2019, our experts updated the already published MDlaw guidance document/template to assist you drawing a detailed Risk…