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Implant Cards: Further MDCG Guidance
The Medical Device Coordination Group (MDCG), the advisory body of the European Commission composed of representatives of all member states, issued a guidance document dedicated to the Implant Card (IC) to advise the...
UDI and Changes to UDI’s: MDCG Guidance
The Medical Device Coordination Group (MDCG), an advisory body of the European Commission composed of representatives of all the EU Member States, issued guidance dedicated to the Unique Device Identification (UDI)...
Explanatory Notes to the UK Medical Devices Bill
In order to assist all parties involved in operations with medical devices to maintain compliance with applicable requirements under the new framework established by the recent UK Medicines and Medical Devices Bill,...
Norway Warns on EUDAMED Delay
Statens legemiddelverk, the Norwegian Medicines Agency, issued an official notice to warn all parties involved in operations with medical devices that have been delayed in the launch of the new European database –...
MedTech Europe Warns on MDR Implementation Issues
MedTech Europe, the association of companies that operate on the medical device market, is deeply concerned with the current situation regarding the implementation of Regulation 2017/745 (MDR). The association warns...