Today, 12 July 2024, the Artificial Intelligence Regulation (AI Act) was published in the Official Journal of the European Union. Regulation (EU) 2024/1689 sets harmonised…
MDR and IVDR changes officially published
Today, 9 July 2024, Regulation (EU) 2024/1860 was listed in the Official Journal of the EU. After the Council approval on 30 May, the latest…
Updated guidance on classification rules for IVDs
MDCG 2020-16 on classification rules for IVDs has been updated in July 2024 for its third revision. The second update came in February 2023 with…
Updated guidance on standardisation for medical devices
In July 2024, the Medical Device Coordination Group (MDCG) updated its guidance MDCG 2021-5 on standardisation for medical devices, first published in 2021. In the…
MDCG on clinical evaluation of orphan medical devices
Today, 25 June 2024, the MDCG (Medical Device Coordination Group) published a guidance on the clinical evaluation of orphan medical devices (MDCG 2024-10). An orphan…
Annex XVI devices: MDR requirements and deadlines
To be placed on the EU market, certain products without an intended medical purpose have to comply with the Medical Devices Regulation (MDR). Annex XVI…
Council formally adopts amendments to MDR and IVDR
Today, 30 May 2024, the Council formally adopted the new rules to amend the Medical Devices Regulations, the MDR and IVDR. The updates bring new…
MDCG on appropriate surveillance for legacy devices
On 27 May 2024, the MDCG (Medical Device Coordination Group) published an updated version of MDCG 2022-4. This document is a guidance on appropriate surveillance…
Future UK recognition of devices from EU, US, Canada, and Australia
The Medicines and Health Regulatory Authority (MHRA) has announced on May 21, 2024, the intention to accept medical devices that already conform to regulations in…
Challenges for combined studies of medicines, IVDs, and devices
In the European Union, there are different regulatory requirements for clinical trials of medicinal products, clinical investigations of medical devices, and performance studies of IVDs.…