Incomplete technical files are still the bottleneck
The European Commission’s latest notified body survey, with data to February 28, 2026, counted 18,010 MDR certificates issued and around 32,000 applications (European Commission). It found that only 14 of 52 MDR notified bodies report that more than half of submissions are complete, concluding: “Incomplete submissions remain high.” Of 989 refused applications, 25% were refused because “Applications not complete.”
For a new QMS plus product certificate, 51% of notified bodies report 13 to 18 months. Every round of questions on an incomplete file adds to that clock.
This checklist walks through the technical documentation required by Annex II and Annex III of Regulation (EU) 2017/745, plus a GSPR compliance matrix template, so your file is complete on the first submission.
For Annex II and III explained, with the findings notified bodies raise most, see EU MDR Technical Documentation: Annex II and III Explained, With Common Notified Body Findings.
What’s changing in 2026
Transition deadlines are fixed for now
Regulation (EU) 2023/607 extended the MDR transition, provided manufacturers met interim conditions (EUR-Lex):
| Deadline | Requirement |
|---|---|
| 26 May 2024 | Formal application lodged with a notified body |
| 26 September 2024 | Written agreement signed with the notified body |
| 31 December 2027 | Class III and most class IIb implantable devices |
| 31 December 2028 | Other class IIb, class IIa, and class I sterile or measuring devices |
A simplification proposal is in progress
On December 16, 2025, the Commission proposed targeted amendments to the MDR and IVDR (COM(2025) 1023), whose “main objective is to simplify the applicable rules, reduce the administrative burden on manufacturers” (European Commission). Key proposals include removing the five-year maximum certificate validity, reducing PSUR update frequency, defining “well-established technology” devices, and letting notified bodies assess technical documentation of “one representative device for a generic device group.”
It is not law yet. As of July 2026, Parliament’s health committee vote was scheduled for December, with a Parliament position expected in early 2027 (DSV). Build your file to the current rules.
EUDAMED is mandatory
The first four EUDAMED modules (actor registration, UDI/device registration, notified bodies and certificates, and market surveillance) became mandatory on May 28, 2026 (BASG). Your technical documentation should be consistent with what you register there.
Annex II and Annex III checklist
The section headings below follow the MDR text as adopted (Annex II; Annex III; official text on EUR-Lex).
Annex II: Technical documentation
- 1. Device description and specification, including variants and accessories. Intended purpose, users, principles of operation, classification and rule applied, Basic UDI-DI, and reference to previous and similar generations.
- 2. Information to be supplied by the manufacturer. Labels and instructions for use in the languages of the target Member States.
- 3. Design and manufacturing information. Design stages, manufacturing processes and validation, and all sites including suppliers and subcontractors.
- 4. General safety and performance requirements. The GSPR matrix (see below), with methods, standards and controlled evidence for each applicable requirement.
- 5. Benefit-risk analysis and risk management. Benefit-risk analysis and the risk management file.
- 6. Product verification and validation. Pre-clinical and clinical data (6.1), including the clinical evaluation report, and additional information in specific cases (6.2) such as medicinal substances, tissues, sterility or measuring function.
Annex III: Post-market surveillance documentation
- 1.1 Post-market surveillance plan under Article 84.
- 1.2 PSUR (Article 86) or post-market surveillance report (Article 85), depending on class.
Submission quality checks from Team-NB
Team-NB’s April 2026 best practice guidance sets clear expectations for what notified bodies receive (Team-NB):
- “Draft documents should not be provided”
- No abbreviated or partial test reports: “Abbreviated or partial test reports are not considered acceptable”
- “Scanned documents are to be avoided”
- References cite “The precise identity of the controlled documents offering evidence of conformity” and “avoid general or generic references”
GSPR compliance matrix template
Annex I of the MDR sets out the General Safety and Performance Requirements in three chapters: “General requirements,” “Requirements regarding design and manufacture,” and “Requirements regarding the information supplied with the device” (Annex I). Team-NB asks for each applicable GSPR, an explanation of why others do not apply, the method used to show conformity, whether “full or partial compliance is being claimed,” and the precise controlled documents that prove it (Team-NB).
A matrix that meets those expectations looks like this:
| GSPR | Applicable? | Justification if not | Method of conformity | Standards / CS applied | Full or partial | Evidence (document ID, version, section) |
|---|---|---|---|---|---|---|
| 1 (performance, safety, benefit-risk) | Yes | – | Risk management, clinical evaluation | EN ISO 14971:2019+A11:2021 | Full | RMF-001 v3 §4; CER-001 v2 §6 |
| 10.x (chemical properties) | No | Device has no patient contact | – | – | – | – |
| 23 (label and IFU) | Yes | – | Labeling review | EN ISO 15223-1 | Full | LBL-010 v4; IFU-002 v5 |
The rows above are illustrative. The common failure is the last column: generic references such as “see test reports” instead of a specific, controlled document and section.
Reviewing a technical file before submission
A final internal review should answer three questions for every Annex II section and every GSPR: is the content there, does the cited evidence actually support it, and is it the current controlled version? That is a lot of cross-referencing across hundreds of documents.
AI document assessment can do the first pass. It maps each document to the Annex II checklist and GSPR matrix, quotes the passage that supports each claim, and flags generic references, missing sections or evidence that does not match the claim. Your RA team then reviews the flags.
Run a sample regulatory document assessment on one GSPR matrix or technical file section. AskDona shows the evidence behind every finding.
FAQ
What does EU MDR Annex II require? Six sections: device description and specification; information supplied by the manufacturer; design and manufacturing information; GSPRs; benefit-risk analysis and risk management; and product verification and validation (Annex II).
What is a GSPR compliance matrix? A table showing, for each Annex I requirement, whether it applies, how conformity is shown and which controlled documents prove it.
When is the MDR transition deadline? December 31, 2027 for class III and most class IIb implantables; December 31, 2028 for other classes covered, if the 2024 conditions were met (EUR-Lex).
Will the 2025 MDR reform change technical documentation? Possibly, for example by allowing notified bodies to assess a representative device per generic group. It is still a proposal (European Commission).
Why do notified bodies reject applications? In the Commission’s survey, the main reasons for refusal were scope outside the notified body’s designation (30%) and incomplete applications (25%) (European Commission).
References
All pages opened and checked by October 9, 2026.
| Source | Type | Date | Used for |
|---|---|---|---|
| EUR-Lex: Regulation (EU) 2017/745 | Regulation | 2017 | Official MDR text |
| Legislation.gov.uk: MDR Annex I, II, III (as adopted) | Regulation text copy | 2017 | Annex headings |
| EUR-Lex: Regulation (EU) 2023/607 | Regulation | Mar 15, 2023 | Transition deadlines |
| European Commission: COM(2025) 1023 | Proposal | Dec 16, 2025 | Simplification proposals |
| DSV: MDR/IVDR reform status | Policy news | Jul 2026 | Legislative timeline |
| European Commission: Notified bodies survey | Regulator data | Jul 2, 2026 (data to Feb 28, 2026) | Certificates, completeness, refusals |
| Team-NB: Technical documentation best practice v4 | Notified body association | Apr 21, 2026 | GSPR matrix and submission quality |
| BASG: EUDAMED mandatory modules | Regulator (Austria) | Dec 2, 2025 | EUDAMED dates |
Note: the reform’s legislative status is as of July 2026; check for updates before publishing.