If you wish to have more information about the new Nomenclature, Obelis Experts will assist you in ensuring compliance of your IVD medical devices.
News
The European Medical Device Nomenclature (EMDN): Background and Generalities
The CND classifies medical devices in three different levels – Category (first level), Group (second level) and Type (third level) – following an alphanumeric structure.
New amendments brought by Regulation 2019/1966 on CMR Omnibus
Read more about the New amendments brought by Regulation 2019/1966 on CMR Omnibus
Brexit – Last update
Brexit officially enters into effect on January 31 2020. Find out what implications it has for your products and practices as Britain leaves the European Union.
Have your say: Labelling fragrance allergens
Have your voice heard by the EU Commission. How to provide feedback on fragrance ingredients for cosmetics products on the EU market.
EDPS Opinion on clinical research and data protection
Read more about the opinion of the European Data Protection Supervisor holds for the implications of GDPR on clinical research conducted within the EU.
The European Commission has published a FAQ document on UDI
Throughout the many changes the EU Medical Device Regulations 2017/745 and 2017/746 will bring, one equally important is the introduction of a device traceability system based on Unique Device Identification, most commonly mentioned as UDI, within the healthcare supply chain. Read more about it here.
Silicones on the spot – again
Cyclopentasiloxane (D5) and Cyclotetrasiloxane (D4), two of the most common silicones used in cosmetic products, were recently restricted for use in the European Union.
Danish competent authority bans phthalates and boron releasing toys
As squishy and slime toys are becoming increasingly popular among children, many EU member states have been strengthening inspections for harmful chemicals in their composition.
Type-approval for vehicles: Revised General Safety Regulation enters into force
As of July 2022, the new rules require all vehicle models introduced on the European market to be equipped with advanced safety features.