Essentials of European Medical Device Regulatory Affairs

Classification of medical devices

Classification in the MDD and MDR MDD Art.9, MDR Art.51 • Class III - highest risk • Class IIb - medium to high risk • Class IIa - medium risk • Class I - lowest risk (measuring, sterile, reusable)

• Risk classification is based on the manufacturer’s intended purpose

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Classification of medical devices Classification criteria

MDR Annex VIII • Duration of contact:

- Transient, Short term, Long term

• Degree of invasiveness:

- Implantable, Surgical, Body orifice

• Anatomy affected • Active / Non-active

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