European Union

• The pathway to the CE mark | Swedish Medical Products Agency | Läkemedelsverket (lakemedelsverket.se)
• Manufacturers – The European Union Medical Device Regulation (eumdr.com)
• Medical device rationale – The European Union Medical Device Regulation (eumdr.com)
• DocsRoom - European Commission (europa.eu)
• Access the Official Journal - EUR-Lex (europa.eu)

United States

• Medical Devices | FDA
• Premarket Notification 510(k) | FDA
• Center for Devices and Radiological Health | FDAHome | ClinicalTrials.gov
• Home | ClinicalTrials.gov
• Drugs | FDA

United Kingdom

• Regulating medical devices in the UK - GOV.UK (www.gov.uk)

Information from regulators

• The European Union Medical Device Regulation – Regulation (EU) 2017/745 (EU MDR)
• Documents | International Medical Device Regulators Forum (imdrf.org)
• EUROPA – European Commission – Growth – Regulatory policy - SMCS

Other links

• WHO Quality Technical Expert Network
• Health technology assessment - European Commission (europa.eu)

Back to Compliance Hub homepage