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CE Certificate Renewal Deadline is Approaching
  All medical device manufacturers should be aware that the last CE certificate renewal deadline expires later this month. Those who miss it could face regulatory issues, delays, and additional expenses. CE Certificate...
EU Medical Device Regulations
The adoption of Medical Device Regulation is a new step towards the improvement of the medical device regulatory framework. Regulation 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical...
The EMA Published Draft Guidance on DDC Products.
European Medicines Agency issued a new draft guidance related to drug-device combinations. This particular regulation specifies the necessary documents for the application for marketing authorization for these types of...
A Guide to Enter Your Medical Device in Italy
Medical devices in Italy are subject to the same regulations as all countries in the European Union (EU) which were implemented in 2017. Here, you can find out more information on the EU MDR and IVDR regulation....