EUDAMED: State-of-play
Despite projections that it will be possible to perform device and Certificate registration directly to…
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Overview of published documents – February 2021
To improve MDlaw experience, and keep you informed of all the relevant documents of the…
MDCG Guidance on practices and solutions until EUDAMED is fully functional
MDCG issued its first 2021 guidance that clarifies to Member States and other parties on the…
MDR: 19th Notified Body on NANDO!
The NANDO database newly lists 19 Notified Bodies under the MDR! ISTITUTO SUPERIORE DI SANITA…
EUDAMED Management of Legacy Devices
The European Commission recently published Management of Legacy Devices (version 1.1, issued on 08.02.2021.), a…
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…
UDI assignment for Spectacle lenses & Ready readers
The MDR is introducing the obligation of manufactures to assign the Unique Device Identification (UDI)…
MDR: 18th Notified Body on NANDO!
The NANDO database newly lists 18 Notified Bodies under the MDR! UDEM Adriatic is the…
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