The Medical Devices Introductory Course 2020

Technical Documentation Hints

• The included devices must be described and listed • For each device the product class must be stated and the rationale given • Each section should demonstrate how conformity has been achieved • Supporting evidence (for example: test results, validations, clinical studies, etc) should be supplied, referenced and summarised • Should be clear and easy for the NB reviewer to review! • For drug-device combination products an ancillary medicinal product dossier must be submitted as well • Hint: Do gap analysis and identify and address any new requirements • Hint: For legacy devices include PMS Report. For new devices include PMS Plan

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The Organisation for Professionals in Regulatory Affairs

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Technical Documentation NB Assessment

Initial / Surveillance

Class I

Never / Never

Class IIa Class IIb

On a sampling basis / On sampling basis On a sampling basis / On sampling basis for implants as for class III

Class III

Every device / Every device

• For class III and class IIb implants the NB issues an EU Technical Documentation Assessment Certificate (was EC Design Examination Certificate) • For drug-device combination products, etc Competent Authority (or EMA) assessment and approval is also necessary

HOWARD DOBBS

The Organisation for Professionals in Regulatory Affairs

38