Reclassifying a medical device under the MDR is one of the most destabilising situations a manufacturer can face. A device marketed for ten years as class I under Directive 93/42/EEC that becomes class IIa under the MDR: it is the entire regulatory approach that changes, not just a few documents to update.
The most frequent reclassifications under the MDR
Software. Rule 11 of Annex VIII has reclassified thousands of software products from class I to higher classes. Diagnostic decision-support software that was class I under the Directive is in principle class IIa under the MDR, and moves to IIb or even III if its errors could cause a serious or irreversible deterioration of health, or death.
Reusable surgical instruments. They remain class I under the MDR but fall into the new Ir sub-class: whereas they were self-certified under the Directive, a notified body must now assess the aspects relating to their reuse (cleaning, disinfection, sterilisation, maintenance, functional testing and the related instructions, Article 52(7)).
Spinal implants and resorbable devices. Rule 8 places spinal disc replacement implants and implantable devices in contact with the spinal column (except components such as screws, wedges, plates and instruments) in class III. Resorbable devices fall under Rule 7 when they are short-term surgically invasive (class IIb if wholly or mainly absorbed) and under Rule 8 when they are implantable (class III). Rule 22, often wrongly cited on these topics, covers active therapeutic devices with an integrated diagnostic function, which are class III.
What reclassification means in practical terms
The move from class I to class IIa is probably the most structurally significant change: from self-certification, you move to the requirement for a notified body. This change means building or strengthening the QMS in accordance with the requirements of Annex IX, compiling complete technical documentation in accordance with Annex II with a substantial clinical evaluation, selecting and contracting with a notified body, and planning for a radically different budget and timeline.
The move from class IIa to IIb does not change the basic procedure (a notified body is still required) but increases the level of requirement for the clinical evaluation and the level of scrutiny the notified body applies to the file.
How to anticipate the transition
The first step is to confirm the new MDR classification as early as possible. If reclassification is confirmed, it is a regulatory reality — denying it or hoping for a different interpretation only reduces the time available to prepare for it.
The second step is to build a transition plan that integrates the MDR certification activities into the company’s schedule. For a device that was class I under the Directive, whose declaration of conformity was drawn up before 26 May 2021 and which now requires a notified body, the transitional regime allows it to remain on the market until 31 December 2028 (Article 120(3ter)). That period only applies if the conditions of Article 120(3quater) were met in time: in particular a QMS compliant with Article 10(9) in place by 26 May 2024, a formal application lodged with a notified body by 26 May 2024 and a written agreement signed by 26 September 2024. Otherwise, the device can no longer be placed on the market without an MDR certificate.
The third step is to assess the economic impact. A reclassification from I to IIa represents an investment of 60,000 to 120,000 euros and 18 to 24 months of work. For some low-volume or low-margin devices, this investment must be weighed against the commercial strategy.