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EU, Canadian, and Global Regulatory Resources

Regulatory requirements in the EU and Canada are subject to revision.  Below you will find the most maintained, up-to-date regulatory guidance offered by the standard bodies to ensure that your path starts and follows a positive course.

European Union

EU Medical Device Regulations Revision

Revision of the EU Medical Device Legislation.

EU Legislation

Comprehensive source for EU regulation regarding medical devices.

EU Guidance Documents (MEDDEVs)

Guidance documents to assist in EU regulatory compliance.

European Association of Authorized Representatives

EU recognized association of organizations that provide European Authorized representative services for non-European manufacturers.

Competent Authority Contacts

Listing of EU National Competent Authorities regarding general contact, vigilance, and clinical investigation.

Canada

Legislation and Guidelines

Overview of legislation and guidelines for medical devices.

Medical Device Regulations (SOR/98-282)

Canadian Medical Device Regulations

Guidance Documents

List of documents to assist in medical device and quality procedure compliance.

Recognized Registrars

List of registrars recognized by Health Canada.

Global Initiatives

International Medical Device Regulators Forum

Forum dedicated to global medical device harmonization.

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