The EU Medical Device Regulation (MDR, Regulation (EU) 2017/745) sets detailed rules for classifying medical devices. Manufacturers must classify their products according to Annex VIII, based on intended purpose, invasiveness, duration of use and inherent risks, and then choose the appropriate conformity assessment route.
Classification rules (Annex VIII)
- Rules 1–4 – non-invasive devices: devices that do not enter the body or only contact intact skin.
- Rules 5–8 – invasive devices: devices entering the body through a body orifice or the surface of the body, including surgically invasive and implantable devices.
- Rules 9–13 – active devices: devices relying on a source of energy other than that generated by the human body or gravity, including software (Rule 11).
- Rules 14–22 – special rules: for example devices incorporating medicinal substances, devices for contraception, disinfecting products, devices containing nanomaterials or substances absorbed by the body, and devices without an intended medical purpose (Annex XVI).
If several rules apply, the strictest rule – resulting in the higher class – applies.
Conformity assessment routes
Class I
The manufacturer draws up the technical documentation (Annexes II and III), demonstrates conformity with the general safety and performance requirements (GSPR) and signs the EU declaration of conformity – no notified body is involved (Article 52(7)).
Class Is, Im and Ir
Class I devices placed on the market in sterile condition (Is), with a measuring function (Im) or reusable surgical instruments (Ir) require a notified body, limited to the aspects relating to sterility, metrology or reprocessing. The manufacturer applies Annex IX, Chapters I and III, or Annex XI, Part A (production quality assurance).
Class IIa
- Annex IX (quality management system assessment, Chapters I and III), with assessment of the technical documentation of at least one representative device per category of devices; or
- Annex XI – Part A (production quality assurance) or Part B (product verification) – combined with technical documentation according to Annexes II and III.
Class IIb
- Annex IX (Chapters I and III), with assessment of the technical documentation of at least one representative device per generic device group (implantable class IIb devices: every device, with exceptions such as sutures, staples, dental fillings, screws, plates and similar); or
- Annex X (type examination) combined with Annex XI (Part A or Part B).
Class III
- Annex IX – full quality assurance with assessment of the technical documentation (Chapter II) for each device; or
- Annex X (type examination) combined with Annex XI (Part A or Part B).
Additional procedures apply to certain devices – for example the clinical evaluation consultation procedure with an expert panel for class III implantable devices and class IIb active devices intended to administer or remove medicinal products (Article 54), consultation of a medicines authority for devices incorporating a medicinal substance, and specific requirements for devices using tissues or cells of animal origin. Manufacturers should choose the route that best fits their product and work closely with their notified body.
Understanding and correctly applying the MDR classification rules and conformity assessment routes is essential for regulatory affairs teams – it determines both compliance and access to the EU market.
How EVERBIZ can help
EVERBIZ GmbH in Munich supports manufacturers with MDR classification, choice of conformity assessment route, technical documentation, notified body applications and EU Authorised Representative services. Contact us.
This article is for general information only and does not constitute legal advice. The text of Regulation (EU) 2017/745 is authoritative.