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MHRA Regulatory Flexibilities and COVID-19 Response
The Medicines and Healthcare products Regulatory Agency (MHRA), the UK authority responsible for medical devices regulation, announced a set of measures taken to address hazards caused by the outbreak of Coronavirus...
COVID-19: EC Recommendations and Assessment
The European Commission (EC), the European authority responsible for medical device regulations, issued recommendations on conformity assessment and market surveillance procedures within the context of the threat...
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)...
MHRA Guidance on Medicines and Medical Devices
MHRA Guidance on Medicines and Medical Devices  The Medicines and Healthcare products Regulatory Agency (MHRA), the UK authority responsible for medical devices regulation, published updated guidance on distinguishing...
Team NB Position Paper on Dental Implants
The European Association of Medical Devices – Notified Bodies (Team NB) issued a position paper describing the application of an exemption rule regarding the endosseous dental implants and dental implant abutments....