In June 2023, the European Parliament adopted its position on the Artificial Intelligence Act (AI Act). Lawmakers have already started their negotiations to define the…
US and EU regulatory systems for medical devices in comparison
Switzerland relies significantly on imported medical devices. With the implementation of the EU Medical Devices Regulation (MDR) and a mutual recognition agreement (MRA) terminated in…
Update on EUDAMED state of play
The European Commission has released new minutes of the MDCG EUDAMED working group meeting of June 29, 2023. Among other topics covered in the minutes,…
New flowchart on the scope of MDR legacy period extension
On 23 August 2023, the European Commission has released a new flowchart to assist manufacturers in deciding whether the MDR transitional period extension covers a…
Swissdamed: roll-out plan of the Swiss database on medical devices
Like the European Union, also Switzerland implemented the obligation to register medical devices and IVD medical devices marketed in their territory – to an online…
NB Position Paper on the new MDR transition timelines
On 10 August 2023, Team-NB, the European Association of Medical Devices Notified Bodes, published a position paper on the “New MDR Transition Timelines and Notified…
Legacy device manufacturers: Important deadlines & steps
Legacy devices are devices that are typically covered by a valid CE Certificate or are being up-classified by the Regulations and benefit from a special…
United Kingdom: CE marking recognition for medical devices and IVDs
Following the government’s decision to extend the CE mark recognition for a wide range of products, the UK announced that for medical devices, the deadlines…
Updated Notified Bodies survey on MDR/IVDR certifications and applications
The European Commission has issued an updated document on their survey conducted among Notified Bodies on certifications and applications under the Medical Devices Regulation (MDR) and the…
European Commission updates factsheet for non-EU/EEA authorities
The European Commission has published an updated factsheet for authorities in non-EU/EEA states on medical devices and in vitro diagnostic medical devices. This factsheet seeks…