Frequently asked questions

Usually 12 to 24 months, depending on the device class, the maturity of your quality system and the state of the technical documentation. The further along the clinical evaluation, the shorter the timeline.

As early as possible, ideally from the design stage: fixing a regulatory direction after the file has been submitted costs far more than scoping it upfront.

Yes, if the device genuinely qualifies as class I. It is a common market-entry strategy, provided you do not underestimate its actual classification.

No, it is not formally mandatory, but it is the functional equivalent of the quality system required by MDR Article 10: in practice, it is the safest route to demonstrate compliance.

Usually 9 to 12 months from setting up the quality management system to the certification audit, depending on your starting point.

The internal audit is run by the organisation to check its own system; the certification audit is carried out by an accredited third-party body that issues the certificate.

As soon as it places a medical device on the European Union market: the MDR requires an authorised representative established in the EU as the point of contact for the authorities.

Verifying documentary compliance, keeping the technical documentation, cooperating with the authorities, registering the manufacturer in EUDAMED and relaying vigilance.

Yes. The change is planned (documentation transfer, EUDAMED update, notified body information) to avoid any break in compliance.

Yes: our courses are run by a Qualiopi-certified organisation, which opens up funding through OPCOs and other schemes.

Yes, every course can be delivered in-house, tailored to your products and level, in person or as a virtual classroom.

Yes: virtual classrooms and e-learning modules, in addition to open-enrolment and in-house sessions.

The elements of MDR Annexes II and III: device description, general safety and performance requirements, clinical evaluation, risk management and post-market surveillance.

The person responsible for regulatory compliance: a mandatory role under the MDR, accountable for compliance, technical documentation and vigilance.

The European database on medical devices. Manufacturers, authorised representatives and importers must be registered (economic operators, devices, certificates).