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…
6th and 7th MDR Notified Body designated
The European Commission announced two more Notified Body designations under the Medical Device Regulation in the last two days: DARE!! Services B.V. Vijzelmolenlaan 7 NL-3447…
EUDAMED delayed!
The European Commission officially announced the delay of the EUDAMED database to May 2022: ” The Commission concluded that it will only be possible to…
Timeline for future MDCG documents published!
Albeit half of the deadlines for the endorsement of MDCG Guidance is not yet defined (TBD), however here below we present the documents that shall…