Module 14: Design Development and Certification of Medical Devices

17/11/2023

Conformity Assessment - MDR

Class I

•Self-certification •Approved bodies needed for Sterility and metrology

Class IIa

•Examination and testing of each product- Annex IV Part II •Audit of the production quality assurance system – Annex V Part II •Audit of final inspection and testing – Annex VI Part II •Audit of full QMS – Annex II Part II

Approved Body

Class IIb

•Annex II part II •Annex III part II

Class III

•Annex II Part II •Annex III Part II

https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/948316/Conformity_assessmen t_routes_chart_Nov15.pdf

The Organisation for Professionals in Regulatory Affairs

Diverging approaches to MD requirements – EEA and UK

13

UK Approved Notified Bodies

MDs Covered

BSI (0086)

DEKRA (8505)

SGS (0120)

UL Int. (0843)

TUV Rheinland (2571)

TUV SUD (0168)

Intertek (8532)

Medical Devices

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Active Implantable Medical Devices In-vitro Diagnostic Medical Devices

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https://www.gov.uk/government/publications/medical-devices-uk-approved-bodies/uk-approved-bodies-for medical-devices

The Organisation for Professionals in Regulatory Affairs

Diverging approaches to MD requirements – EEA and UK

14

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