UK Medical Device Regulation

UK Medical Device Regulation - www.omcmedical.com

UK Medical Device Regulation

United Kingdom Medical Device Regulations

UK – Medical Device Requirements

UK- Medical Device Requirements - omcmedical.com

UK MDR

UK MDR - omcmedical.com

Role of MHRA

UK Approved Bodies

UK Approved Notified Bodies

Update from NB’s

Manufacturers

MFRA Manufacturers - omcmedical.com

Authorised Representatives

Importer & Distributor

Registrations in Great Britain

Registration Timeline – UK

Registration Timeline - UK - omcmedical.com
Device Registration work flow - omcmedical.com

Registration Data

• Copy of Declaration of Conformity
• E-copy of technical documentation
• Device Certificate as granted by the Notified Body
• Quality Management Certificate
• Database information Manufacturing details
• Letter of Designation
• Contact persons and list of importers
• Database information Device Details
• Database information Product Details
• Catalog/Reference (REF)
• Unique Device Identification

Responsibility of UK – Responsible Person

Responsibility of UK Responsible Person - omcmedical.com

Labelling Requirements

Post-market surveillance and vigilance

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