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…
COVID-19 & NB audits: MDCG Q&A
The MDCG issued a Questions & Answers (Q&A) document concerning the previously issued Guidance on temporary…
Actor registration to EUDAMED is now possible!
Actor module of EUDAMED is active as of December 1, 2020! It is now possible…