Class IIa devices represent a significant share of the European medical device market: hearing aids, contact lenses, cannulas, certain dental implants, urinary catheters, ultrasound equipment. For these devices, a notified body is mandatory. Understanding what its involvement means in practice makes it possible to anticipate timelines and to build a suitable technical documentation file.
What the NB examines for a Class IIa device
Under the Annex IX procedure (the most common one), the notified body examines two elements.
The manufacturer’s QMS. The auditor verifies that the QMS covers all the processes listed in Article 10(2) of the MDR, going beyond the ISO 13485 requirements alone: clinical evaluation, PMS, the PRRC, and the link to EUDAMED are specific MDR points of attention.
The technical documentation of a representative sample. For Class IIa, the NB selects one or more devices that are representative of the manufacturer’s range. It does not systematically examine every reference — but it must justify the representativeness of its sample. If your range includes devices that are very different in design or intended use, several files may be examined.
The most closely scrutinised aspects of the Class IIa file
Clinical evaluation. The CER is examined systematically. For Class IIa, the equivalence demonstration route is still feasible if the criteria of Article 61.5 are met. However, the quality of the equivalence demonstration — across the three technical, biological and clinical dimensions — is scrutinised closely. Vague or incomplete equivalence claims generate requests for additional information.
The PMS plan and the PSUR. The NB verifies that the PMS plan exists and is credible: defined collection methods, identified data sources, specified update frequency. For Class IIa, the PSUR must be produced at least every two years.
The PMCF plan. It must address the clinical gaps identified in the CER. A generic PMCF with no link to the specific gaps of the device is insufficient.
Realistic timelines for Class IIa
A first certification cycle for Class IIa, starting from a complete technical documentation file, takes 9 to 18 months depending on the NB, the manufacturer’s level of preparation, and the complexity of the device. This timeline includes the initial contact and contracting with the NB, the documentation review, the planning of the on-site audit, the audit itself, the handling of any non-conformities, and the issuance of the certificate.