Croatia has started presiding the Council of the European Union on the 1st of January 2020, and will remain in this role until the 30th…
MDCG Guidance on cybersecurity for MD
The European Commission published today a new MDCG Guidance, which is 16th in line, and has the purpose to help medical device manufacturers and other…
MEDCERT designated under the MDR (9th NB)
With the below German Notified Body, designated for the assessment of devices under the MDR – (EU) 2017/745, we reached the number of 9, despite…
IVDR: 3rd NB accredited
Today, the European Commission updated the NANDO database by adding another Notified Body accredited for the assessment of devices under the In Vitro Diagnostic Medical…
MDCG Guidance timeline updated
Today, an updated version of the MDCG work progress was released, listing past and ongoing development of guidance documents within MDCG Subgroups. We shall still…
MDCG Guidance for Class I manufacturers!
The MDCG published today well awaited Guidance for Class I manufacturers! The MDCG enlists tasks to be carried out by a Class I manufacturer to…
8th NB designated under MDR
NANDO database is richer for another Notified Body accreditation under the Medical Device Regulation – (EU) 2017/745. Dutch Notified Body DEKRA is the 8th NB…
MDCG Guidance on MDR/IVDR device sampling + MDR Codes
The MDCG published two important guidance documents this afternoon. Firstly, an Explanatory note on MDR Codes, i.e. MDA/MDN, MDS, MDT was published. These Codes are…
UDI issuing entities on Basic-UDI and UDI formats
The four accredited UDI issuing entities (which were designated by the Commission Implementing Decision of 7 June 2019) released further specifications on Basic UDI-DI and…
MDR Corrigendum: Derogation for certain up-classified devices
The rumors on the revised transitional provision [Article 120(3) of the MDR] are confirmed, as a new version of the Corrigendum was published. However, the…