Module 5 Presentations

16/07/2024

Classification Rules (MDR)

• Europe uses a rule-based system for the classification of medical devices (Article 51, Annex VIII of the Medical Device Regulation EU 2017/745). The MDR has four main risk-based categories:

• Class 1 (low risk). Example: band-aid, manual wheelchair.

• Class 1 measuring function. Example: thermometer, weighing scale.

• Class 1 sterile. Example: sterile urine bags.

• Class 1 reusable surgical instrument. Example: surgical scissors.

• Class IIa (medium risk). Example: hearing aids, diagnostic software (SaMD) .

• Class IIb (medium/high risk). Example: blood bags, ICU monitoring equipiment, ventilators.

• Class IIb implantable. Example: Implantable dental devices.

• Class III (high risk). Example: defibrillators, Implanted prosthetics.

The Organisation for Professionals in Regulatory Affairs

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MDCG 2021-05 R01 July 2024

Use of Standards • always voluntary • except when it isn’t! (eg symbols) Hierarchy • Legal Req: ISO 15189 MedLabs • Example • ISO 14155 Clin Investigation • ISO 20916 Clin Perform (IVD)

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… in the medical devices field in the EU, choosing to use a standard or not belong to the manufacturer within their responsibility on compliance

The Organisation for Professionals in Regulatory Affairs

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