The European Commission recently published Management of Legacy Devices (version 1.1, issued on 08.02.2021.), a document that further clarifies the registration of Legacy devices on…
Overview of published documents – January 2021
To improve MDlaw experience, and keep you informed of all the relevant documents of the previous month that have been collected in our Library of…
Dedicated webpages on MDR & IVDR (European Commission)
The European Commission has released dedicated webpages, which are divided in several areas, where you can find relevant Factsheets, Implementation timeline and other helpful documents:…
New MDR NB & UK MHRA Guidance & QMS Remote Audits
SGS FIMKO OY has joined the list of certification bodies notified under the Regulation (EU) 2017/745 on medical devices and displayed on the NANDO website…
MDR & IVDR: How many NBs we have?
The end of Brexit transition period (31/12/2020) has brought many important changes also for the medical device community. Today, we highlight the removal of UK-based…
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 by the European Commission and respective dates of publication: Q1…
UDI assignment for Spectacle lenses & Ready readers
The MDR is introducing the obligation of manufactures to assign the Unique Device Identification (UDI) on their devices, in order to improve the identification of…
MDR: 18th Notified Body on NANDO!
The NANDO database newly lists 18 Notified Bodies under the MDR! UDEM Adriatic is the 18th Notified Body (17th within the Union) notified under the…
COVID-19 & NB audits: MDCG Q&A
The MDCG issued a Questions & Answers (Q&A) document concerning the previously issued Guidance on temporary extraordinary measures related to medical device Notified Body audits during COVID-19…
Actor registration to EUDAMED is now possible!
Actor module of EUDAMED is active as of December 1, 2020! It is now possible to register yourself as an economic operator and obtain the…