MDCG (Medical Device Coordination Group) stated in the newly published guiding principles for issuing entities rules that the Basic UDI-DI requirements on format should be…
NEW eBOOKS: How will the new Regulations (MDR/IVDR) impact you?
We are happy to announce the below two new publications that were added to our MDlaw e-shop! MDR eBOOK IVDR eBOOK In approximately 200 pages,…
First NB designated under the MDR !
The European Commission announced the designation of the first Notified Body under the new Regulation on Medical Devices in the NANDO database! The first NB…
IVDR: Team-NB Survey on NB designation process
This time, Team-NB performed a survey on the designation process of Notified Bodies (NBs) under the IVDR and currently: From 20 Team-NB notified bodies…
EC public reply to PIP fraud Petition
The European Commission (EC) published a public letter to the PIP Implants World Victims Association and rejected the petition to claim the financial compensation at…
New UK guidance: ”no deal” scenario
The UK Government issued a new guidance in the beginning of the year on how a ”no deal” Brexit will affect the regulatory framework of…
TEAM-NB Survey on NB Designation process
The Team-NB performed a new survey in December and collected the data on the designation process of Notified Bodies under the MDR. On the date…
NB express concerns on MDR application date
Team-NB and NB-MED issued a White paper on the occasion of 26 November 2018 – 1 year after the designation process of Notified Bodies under…
New judgment of the CJEU: Access to Documents on NB
On the 5th of December 2018, the General Court (the Court) delivered a judgment (currently only in French and Italian language) on access to documents…
European Commission publishes NEW Information sheets
The European Commission has published today 9 Factsheets related to the MDR and IVDR. The documents present main changes, new requirements, transition timeline and frequent…