The MDCG has updated the useful Questions & Answers document focusing on the Notified Bodies’ requirements under MDR and IVDR. It widens the scope of…
SOFTWARE: Qualification and classification
On the 11th of October 2019, the MDCG issued a Guidance on the qualification and classification of software under the MDR and IVDR. The MDCG…
NB designation process – Final Assessment Form
You can have a look at the final assessment form for the designation of a Notified Body under MDR and IVDR, used by the Designating…
DEKRA is the first NB accredited for the IVDR
This morning, the European Commission updated the NANDO database, by adding the first Notified Body that was designated under the Regulation (EU) 2017/746 on in…
First Guideline on cybersecurity of medical devices incorporating software (MDIS)
Becoming increasingly important also for the med tech sector in view of the technical advancement, cybersecurity aims at incorporating measures, both technical and organisational, that…
Public consultations: reprocessing of single-use MD and cybersecurity
Public consultations have opened for the below two documents: → Commission Implementing Regulation concerning reprocessing of single-use medical devices (rules and common specifications) until 20th…
MDCG releases guidance on Person Responsible for Regulatory Compliance
On July 1st 2019, a MDCG guidance has been published to better clarify the role of PRRC. The main clarifications focused on qualification of the…
UDI issuing entities: first names revealed
The European Commission was mandated and released a draft Commission implementation Decision together with the Annex listing the following four issuing entities designated to operate…
MDCG Q&A for Notified Bodies
The MDCG has just published useful Questions & Answers document, especially relevant for the Notified Bodies. It focuses on the Notified Bodies’ requirements under MDR…
MDCG: When pre-market consultation of expert panel is not required
MDCG (Medical Devices Coordination Group) endorsed a Document, where it further explains the Article 54(2)b that was so far subject to different interpretations. Second paragraph…