EU MDR training: device classes, CE marking and ISO 13485

How does CE classification of medical devices work?

The MDR sorts every device into class I, IIa, IIb or III, from lowest to highest risk. The 22 rules in Annex VIII do the sorting. They ask how long the device stays in the body, whether it is invasive, whether it is active, and which organ it touches. A device that touches the heart or central circulation lands high. When two rules apply, the stricter one wins.

The class then sets the route to the CE mark:

1. Class I. The maker writes the technical documentation, signs the declaration of conformity and affixes the CE mark. No outside body checks it, unless the device is sterile, measures something or is a reusable surgical instrument.
2. Class IIa and IIb. A Notified Body audits the quality system and samples the technical documentation.
3. Class III. The Notified Body reviews the technical documentation of each device in full. For some implants an expert panel can be asked for its view too.

Is ISO 13485 certification for medical devices required under the MDR?

The MDR itself does not name a standard. It requires every maker to run a documented quality management system, scaled to the risk class. EN ISO 13485 is the harmonised standard for that system. Following it gives a presumption of conformity, so in practice almost every Notified Body audits against it. ISO 13485 shares much of its logic with ICH Q10 for medicines: management review, document control, CAPA, supplier control. A pharma quality team that knows ICH Q10 is already halfway there. Risk management follows ISO 14971, which plays the role ICH Q9 plays for medicines.

Which medical device certifications does a company need?

For a class IIa, IIb or III device, the route runs through a Notified Body certificate, which depends on the conformity route chosen: a quality management system certificate, and for class III and implantable class IIb devices a technical documentation certificate as well. The maker then signs its own declaration of conformity. ISO 13485 certification from an accredited registrar is useful evidence, but it is not the CE certificate. The device also needs a unique device identifier and, as the system goes live, registration in EUDAMED, the European device database.

When does a drug-device product fall under the MDR?

This is where pharma companies get caught. A device whose main action is physical, but which carries a medicine for a supporting action, stays a device. The Notified Body must then ask a medicines authority for its opinion on the medicine part. A medicine whose action is pharmacological stays a medicine, even if it comes in an autoinjector. MDCG 2022-5 is the guidance that settles the borderline cases with worked examples. The course below on combination products teaches that decision step by step. The quality and supplier courses cover the system a European device or drug buyer will audit you on.

This guide belongs to Training for Regulatory affairs in pharma: 227 audio courses, 227 courses.