Today, 13 March 2024, the European Parliament approved the text of the Artificial Intelligence Act. In December 2023, Members of the Parliament endorsed the AI…
MDCG Guidance on Clinical Investigation Plan
The Medical Devices Coordination Group (MDCG) released in March 2024 a new guidance on the content of the clinical investigation plan for clinical investigations of…
MDR: 44th Notified Body on NANDO!
The NANDO database has a new Notified Body under the MDR! RISE Medical Notified Body AB is the 44th EU Notified Body notified under the…
MHRA on future UK law on medical devices
On 5 March 2024, the UK MHRA (Medicines and Healthcare Products Regulatory Agency) held the MedTech Regulatory Reform Webinar. This online webinar provided insight into…
Team-NB issues recommendations on the classification of SARS-CoV-2 IVDs
Team-NB, the European Association of Medical Devices Notified Bodies, has released a position paper providing recommendations for manufacturers of IVDs intended to detect the presence or the…
Council adopts IVDR legacy extension and sooner mandatory use of EUDAMED
On 14 February 2024, the Council of the European Union endorsed the European Commission’s proposal for a gradual roll-out of EUDAMED as well as for…
Notified Bodies Survey on MDR and IVDR certifications
In February 2024, the European Commission published the results of the sixth survey conducted until October 2023 on MDR and IVDR certifications and applications. As…
MDCG 2024-02 on EMDN updates
The Medical Device Coordination Group (MDCG) just published the second guidance of the year. MDCG 2024-02, on the procedures for the updates of the European…
MDCG Guidances on vigilance system for CE-marked devices
The Medical Devices Coordination Group (MDCG) has released a new set of guidances on the vigilance systems for CE-marked devices. As such, a template is…
EC Proposal to extend IVD legacy period and make EUDAMED mandatory sooner
On 23 January 2024, the European Commission published a Proposal to extend the IVDs legacy period and make EUDAMED mandatory earlier than planned. With this…