Annexes and Pre-Registration Submission Requirements
Pre-registration assessment is the gate before a notified body accepts an application. The exam tests whether you know which annex supplies each document and what an incomplete submission looks like.
The application (Annex VII, point 4.3)
The manufacturer's application must identify the manufacturer and each manufacturing site, the generic device group, the classification and the chosen conformity assessment route, and must be accompanied by the quality management system documentation, the technical documentation, the clinical evaluation or performance evaluation documentation and the post-market surveillance plan. Applications are lodged for a generic device group, not for a single catalogue number.
Declaration and certificates
Annex IV sets out the EU declaration of conformity: manufacturer identification, device identification including the basic UDI-DI, the conformity route, references to common specifications or standards applied, the notified body's name and four-digit number, the certificate identifier and expiry, and the signature of the person responsible. The declaration must be kept continuously up to date and retained for 10 years (15 for implantables) after the last device. Annex XII fixes the content of notified body certificates, including scope, conditions and validity.
What a pre-registration reviewer checks first
That the intended purpose and indications in section 1 match the labelling in section 2; that the classification decision is documented with every rule considered; that the GSPR checklist covers Annex I Chapters I to III; that the risk management file is dated and consistent with the clinical evaluation; that the PMS plan exists before the certificate rather than after; that the person responsible for regulatory compliance is named with evidence of qualification; and that UDI data are prepared for EUDAMED.
Worked example
An application for a Class IIa device states the conformity route as Annex XI Part B. The reviewer rejects it: under Article 52(3) the available options for Class IIa are Annex IX Chapters I and III or Annex XI Part A, so the route cannot be selected freely.
Traps
Assuming a package insert substitutes for Annex II section 2; issuing the declaration before the notified body number is known without updating it afterwards; and treating a pre-registration review as a legal decision rather than a completeness gate.