Essentials of European Medical Device Regulatory Affairs - June 2020

Chapter V Classification and conformity assessment

Articles 51-60

• Classification of devices

• Annex VIII - Classification rules

• Reclassification of devices

TheOrganisation for Professionals in Regulatory Affairs

Classification of Devices More risky the product the higher the classification

• Class I

eg. tongue depressor

• Sterile • Measuring eg. dosing spoon

• Class IIA • Class IIB • Class III

eg. blood pressure measuring

eg. ventilators eg. heart valve

• Any dispute on classification between NB and company needs to be referred to competent authority

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Classification – Key Concepts

Rules apply according to intended purpose - :

Duration (continuous use):

transient (<60 mins)

short term (<30 days) long term (>30 days)

Invasiveness:

Non-invasive invasive in a body orifice (eyes/stoma) surgically invasive implantable (hip replacement)

Non-Active/Active:

60

20