Essentials of European Medical Device Regulatory Affairs - June 2020

Classification Exercise

Product

Non Invasive (1,2,3,4)

Duration <60mins transient <30daysshort term >30days long term

Rule

Classification

Invasive(5,6,7,8) Specialrules (13- 18)

A Hydrocolloid (creates a

Non-invasive

Short term

4

IIA

moist environment) plasters

B Corrective daily contact lenses

Invasive (in a body orifice)

Short term

5

IIA

C Corrective contact lenses continuous wear for a year

Invasive (in a body orifice)

Long term

5

IIB

D Device for self

Surgically invasive Transient

6

IIB

administration of a medicine (not infusion,but short)

E Dentist hand held mirror

Invasive

Transient

5

I

TheOrganisation for Professionals in Regulatory Affairs

Chapter VI

Clinical evaluation and clinical investigation

Articles 61-82

Witha few MDD notes as still applicable

TheOrganisation for Professionals in Regulatory Affairs

Life Cycle Clinical Evaluation

PostLaunch Activities

Concept

Feasibility

Development

Launch

Prototype development Benchandpre-clinical

Initialclinical evaluation ‒ Literature review ‒ Initialclinical investigations

Clinical investigations to supportCEmark

ObtainCE Mark

Postmarketing surveillance

User testing

Real life studiesto support ‒ Reimbursement ‒ Marketing

Human factors

PMCF studies

Studies onnon CEmarkedproducts

Studies onCEmarkedproducts

78

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