The European Commission services recently issued a Fact sheet on MDR requirements for Transparency and…
Highlights of the week (CEAR)
Clinical evaluation assessment report template released by the MDCG Clinical evaluation assessment report (CEAR) will…
MDR/IVDR Standardisation Request
As we can read in the recently published minutes from the 19th June meeting of…
Update to the NB designation process
The European Commission released an updated overview of the Notified Body accreditation process under the…
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…
Updated EC Implementation Rolling Plan (MDR/IVDR)
The European Commission released an updated Implementation Rolling Plan under the Regulations 2017/745 and 2017/746…
Planning of MDCG guidance documents updated
You will find below the updated document on the ongoing work of the MDCG and…
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…
Planning of MDCG meetings updated
You can see below the MDCG and subgroups meetings, as foreseen for the next 6…
Notified Body designations: Updated State of play
The European Commission released the updated State of play on the designation process of the…
