Essentials of European Medical Device Regulatory Affairs - October 2019

Classification Exercise

Product

Non Invasive (1,2,3,4) Invasive (5,6,7,8) Special rules (13‐18)

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

Rule

Classification

A Hydrocolloid (creates a moist  environment) plasters B Corrective daily contact  lenses C Corrective contact lenses  continuous wear for a year

Non‐invasive

Short term

Invasive (in a body orifice) Invasive (in a body orifice)

Short term

Long term

D Device for self 

Surgically invasive Transient

administration of a medicine  (not infusion, but short)

E Dentist hand held mirror

Invasive

Transient

F Contact lens solution

Special rule

G Breast implants

Surgically invasive Long term

77

Module 5

• Conformity Assessment Process • Key Requirements: - Conformity assessment procedures - Risk Assessment - Technical Documentation - General Safety and Performance Requirements (GSPR) - Notified Body selection

- CE marking - Registration

78