The MDCG released an important Q&A for manufacturers of Class D devices and their certification…
Switzerland: precautionary measure ahead of 26 May 2021
In the light of the upcoming renewal of the Mutual Recognition Agreement (MRA) between Switzerland…
State of the art of COVID-19 rapid antibody tests and state of the art & IVDR
The IVDD requires from the manufacturers to design and manufacture devices in such a way…
EUDAMED: State-of-play
Despite projections that it will be possible to perform device and Certificate registration directly to…
Overview of published documents – February 2021
To improve MDlaw experience, and keep you informed of all the relevant documents of the…
Overview of published documents – January 2021
To improve MDlaw experience, and keep you informed of all the relevant documents of the…
Dedicated webpages on MDR & IVDR (European Commission)
The European Commission has released dedicated webpages, which are divided in several areas, where you…
New MDR NB & UK MHRA Guidance & QMS Remote Audits
SGS FIMKO OY has joined the list of certification bodies notified under the Regulation (EU)…
MDR & IVDR: How many NBs we have?
The end of Brexit transition period (31/12/2020) has brought many important changes also for the…
Update: EC Implementing acts and MDCG Guidance in 2020 & 2021
With the release of the latest Implementation Rolling Plan, we present below future implementing acts/actions…