Articles 52 to 56 of the MDR define the conformity assessment procedures applicable according to the device class. The choice of procedure is far from trivial: it determines the level and nature of the notified body’s involvement, the content of the file to be submitted, and the duration of the relationship with the notified body.
The three main procedures
Annex IX — Assessment based on the QMS and technical documentation.
This is the most widely used procedure. The notified body assesses two distinct but related elements: the manufacturer’s QMS (Annex IX, section 2) and the device technical documentation (Annex IX, section 4).
The QMS assessment covers the same areas as an ISO 13485 certification, but with additional MDR requirements explicitly verified: PMS, vigilance, management of the clinical evaluation, PRRC, EUDAMED. A manufacturer certified to ISO 13485 benefits from a solid documentary basis, but the notified body verifies the specific MDR requirements independently.
For class III devices, the notified body assesses the technical documentation of each device (Annex IX, section 4), including the in-depth review of the clinical evidence and clinical evaluation (section 4.4) and, for certain devices, the consultation procedure of Article 54. This device-by-device assessment also applies to class IIb implantable devices, except for the exemptions in Article 52(4).
The relationship with the notified body under Annex IX is ongoing: initial audit, annual surveillance audits, and a renewal audit every 3 to 5 years.
Annex X — Type examination.
The notified body examines a representative specimen of the device (the “type”) and issues an EU type-examination certificate. This certificate covers that type of device and its variants described in the design file. It is valid for 5 years.
The Annex X procedure does not cover production: it must be combined with the Annex XI procedure.
Annex XI — Production conformity.
Two options are available.
Part A (production quality assurance): the notified body assesses and monitors the QMS limited to the manufacturing, inspection and dispatch processes. Less comprehensive than Annex IX, it does not cover the design processes.
Part B (product verification): the notified body carries out checks on a sampling basis of finished products, to ensure conformity with the approved technical documentation.
Which procedure for which class?
Class I: self-certification, without a notified body, except for classes Is (sterile), Im (measuring function) and Ir (reusable surgical instruments): a notified body then assesses the specific aspects (sterile condition, metrology, reuse), in accordance with Article 52(7).
Class IIa: Annex IX (QMS + examination of a sample of technical documentation), or technical documentation under Annexes II and III combined with Annex XI, Section 10 (Part A) or 18 (Part B).
Class IIb: Annex IX, or Annex X combined with Annex XI.
Class III: Annex IX with assessment of the technical documentation of each device, or Annex X combined with Annex XI Part A.
The practical choice for most manufacturers
The Annex IX procedure is by far the most widely used among manufacturers pursuing a sustainable certification approach. It establishes a structured relationship with the notified body around two pillars — QMS and technical documentation — and enables coherent management of the device’s evolution over time.
Regulatory source: Articles 52 to 56 of Regulation (EU) 2017/745 — EUR-Lex