IVDR Certification of Class D devices, Implementation Plan and MDR NB
The MDCG released an important Q&A for manufacturers of Class D devices and their certification…
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Switzerland: precautionary measure ahead of 26 May 2021
In the light of the upcoming renewal of the Mutual Recognition Agreement (MRA) between Switzerland…
Language requirements & sanctions under the MDR: Belgium
The text of the Medical Device Regulation (MDR) will become directly applicable on the Union…
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…
MDCG Guidance on MDR custom-made devices
The MDCG issued a dedicated Questions & Answers on the most pertinent matters concerning custom-made…
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…
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…
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