Commission Implementing Regulation (EU) No. 2021/2078:
On 26 November 2021, Commission Implementing Regulation (EU) No. 2021/2078 of 26 November 2021 laying down the rules for the application of Regulation (EU) 2017/745 of the European Parliament and of the Council as regards the European Database on Medical Devices (EUDAMED) was adopted in the Official Journal of the European Union. The regulation is binding in its entirety and directly applicable in all EU Member States and shall enter into force on the 20th day following its publication in the Official Journal of the European Union.
- Entering the self-test into the Central Database of Medicinal Products: You can access the procedure for entering the self-test into the Central Database of Medicinal Products
here.
- Information about SARS-CoV-2 rapid antigen tests: To find out more about SARS-CoV-2 rapid antigen tests, click here.
Urgent field safety notice for the users of the Algivon Honey Dressing and Activon Tube medical product produced by Brightwake Limited, UK.
Urgent field safety notice for the users of the UVA PIT System medical product, produced by PIT Medical Systems GmbH, Germany.
Register economic operators: Applicants can register economic operators (distributors, importers, manufacturers, authorised representatives and manufacturers of custom-made devices) at the Slovenian Business Point (SPOT) portal. For more visit the Regulated entities and their registration subpage.
Swixit: Regarding the European medical devices single market, Switzerland has become a third country as it did not update its mutual recognition agreement with the EU. You can find information for economic operators active in the field of medical devices at Swixit.
- Frequently asked questions (FAQ) on clarifications regarding device safety, specifically on SARS-CoV-2 tests, their components and masks: To access the clarifications regarding some of the frequently asked questions on device safety, specifically on SARS-CoV-2 tests, their components and masks, click here.
Frequently asked questions (FAQ) on regulatory issues regarding COVID-19 tests. The European Commission published a Q&A document on regulatory issues regarding COVID-19 tests.
Brexit: Medical devices and Brexit: Brexit
EUDAMED’s Actor registration module: EUDAMED’s Actor registration module is online (for more information, click here). At the moment, the registration is carried out on a voluntary basis. Registration is validated by the Public Agency of the Republic of Slovenia for Medicinal Products and Medical Devices (JAZMP). You can find the registration requirements in the FAQ document. We kindly ask you to read carefully through the relevant document. The JAZMP only validates operators who submit a digitally or hand-signed statement to the JAZMP.
