In June 2023, the Official Journal of the European Union published the common specifications for…
MDR National implementation: Latvia
Latvia has implemented the Medical Devices Regulation 2017/745 (MDR) through its Medical Device Rule No 461 and…
Regulatory requirements for AI medical devices
In June 2023, the European Parliament adopted its position on the Artificial Intelligence Act (AI…
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…
Update on EUDAMED state of play
The European Commission has released new minutes of the MDCG EUDAMED working group meeting of…
Poland: MDR & IVDR national implementing laws
Upon the publication of the Medical Devices Regulation 2017/745 (MDR) and the In Vitro Diagnostic…
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…
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…
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…
Legacy device manufacturers: Important deadlines & steps
Legacy devices are devices that are typically covered by a valid CE Certificate or are…