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Technical documentation is the single dossier a notified body (for Class B/C/D devices) or a competent authority reviews to decide whether a device can carry the CE mark under Regulation (EU) 2017/745 (MDR). It is not one file — it is a defined set of sections under Annex II, plus a related set of postmarket-surveillance content under Annex III that has to exist alongside it and stay current for the life of the device. This page walks through what actually goes in each section, and where CASRAI’s deeper guides on individual components (the design history file, the clinical evaluation report, the PMS plan) fit into the overall dossier.
Technical documentation is not the same thing as a “technical file”
Under the earlier Medical Device Directive (MDD, repealed and fully replaced by 26 May 2021), manufacturers assembled a “Technical File” for lower-risk devices and a “Design Dossier” for higher-risk ones — two different document sets with different content requirements. MDR collapsed that split: Annex II now defines a single technical-documentation structure that applies to every device class, and “Technical Documentation” is the term the regulation itself uses. “Technical file” still shows up constantly in industry writing and consultancy material as an informal synonym for the same Annex II dossier — if you see the phrase, it almost always means Annex II technical documentation, not a distinct, lower-tier requirement.
The dossier is assembled per device, or per generic device group where MDR allows grouping similar devices under one technical-documentation set — grouping does not remove the obligation to address each Annex II section, it just lets one document set cover several closely related models or sizes.
Annex II: the six sections, and what belongs in each
Annex II is organised into six numbered sections. A notified body’s technical-documentation assessors work through this structure directly, so building the dossier in this order (rather than reorganising it around internal company templates) is what keeps a review efficient.
| Annex II section | What it has to contain |
|---|---|
| 1. Device description and specification | Product identification and UDI-DI, intended purpose and patient population, principle of operation, risk class and the classification rule applied, novel features, all variants/configurations/accessories, and — per the 1.2 sub-point — reference to previous generations of the device and to comparable products already on the market. |
| 2. Information supplied by the manufacturer | Labels and packaging content in every required Member State language, plus the Instructions for Use (IFU) — this is the section reviewers check against Annex I’s labelling and IFU general safety and performance requirements, not just for completeness. |
| 3. Design and manufacturing information | The design stages that produced the finished device, the manufacturing process itself with its validation evidence, and — critically — every manufacturing site, supplier, and subcontractor involved. This is the section most likely to reference the Design History File (DHF) as supporting evidence, though the DHF itself is not the Annex II section — it is the underlying record set a well-organised Section 3 draws from. |
| 4. General safety and performance requirements (GSPR) | A traceability matrix showing conformity with each applicable Annex I requirement — which harmonised standards or common specifications were applied, what method demonstrated conformity, and where the supporting evidence lives elsewhere in the dossier. Reviewers use this matrix as an index into the rest of the file, so gaps here surface as gaps everywhere else. |
| 5. Benefit-risk analysis and risk management | The risk management file’s outputs — hazard identification, risk estimation and evaluation, the risk-control measures actually implemented, and the residual-risk/benefit-risk conclusion, consistent with a risk management process built around ISO 14971. |
| 6. Product verification and validation | Pre-clinical and bench data (6.1), the Clinical Evaluation Report (6.2), and, where a clinical investigation was run rather than relying on equivalence or literature, the clinical investigation report itself (6.3). |
Annex III: the postmarket content that has to exist alongside Annex II
Annex III is not a separate, optional dossier — Article 84 makes the post-market surveillance (PMS) plan an explicit part of the manufacturer’s technical documentation, and Annex III Part A sets out what the plan has to cover: the method for gathering postmarket data, how that data is evaluated against similar devices and the current state of the art, how Post-Market Clinical Follow-up (PMCF) is managed (or a documented, reasoned justification for why PMCF does not apply to that device), the method used to detect trends, and the communication and vigilance procedures that connect back to the incident-reporting obligations in Articles 87–91.
Two components of this get their own deep-dive treatment elsewhere on CASRAI, because each is substantial enough to need one: the PMCF plan itself (Annex XIV Part B, which Annex III requires the PMS plan to reference or formally exclude), and the PMS plan’s own structure and data sources. This page’s job is narrower — showing where Annex III sits relative to Annex II, not re-deriving its content from scratch.
What differs by risk class is the downstream output the PMS system feeds: Class I devices produce a PMS report; Class IIa devices update a Periodic Safety Update Report (PSUR) at least every two years; Class IIb and III devices update a PSUR at least annually, and for IIb/III that PSUR is submitted to the notified body rather than simply held on file.
How far a notified body actually reviews the dossier
Not every device gets the same level of scrutiny, and knowing which review path applies changes how the dossier should be prioritised while it’s being assembled:
- Non-sterile Class I — manufacturer self-declaration; no notified body involvement, and the technical documentation is compiled and held on file rather than submitted for review.
- Sterile Class I / Class Is, and measuring-function Class I / Class Im — notified-body review limited to the sterility or measurement aspects specifically, not a full technical-documentation assessment.
- Class IIa, IIb, III — the notified body reviews the quality management system (typically ISO 13485-based) and the technical documentation itself, with the depth of technical-documentation sampling and assessment increasing by class.
- Class III and implantable / Class IIb active devices intended to administer or remove a medicinal product, and Class D companion-diagnostic-adjacent IVDs, can trigger an additional expert-panel or reference-laboratory consultation step layered on top of the standard notified-body review.
See CASRAI’s EU MDR classification rules guide for how a device’s class is actually determined, and notified body designation and audits for what a notified body itself is and how it is authorised to review MDR/IVDR dossiers.
Where dossiers commonly stall in review
MDR does not publish statistics on why specific technical-documentation submissions are returned, so treat the pattern below as practitioner-reported, not regulatory data — but it recurs consistently enough across regulatory-consulting commentary to be worth checking before submission, not after a deficiency letter:
- A thin or dated state-of-the-art review in the clinical evaluation — literature searches that were not re-run close to submission, or that don’t address comparable devices already on the market.
- Section 3 and the DHF disagreeing with each other — a design change captured in one but not reflected in the other is one of the fastest ways to turn a routine review into a formal deficiency.
- A GSPR matrix that cites a standard without pointing to where the evidence actually lives in the rest of the dossier, forcing the assessor to search for it rather than follow a reference.
- A PMCF justification that isn’t actually reasoned — Annex III requires either a real PMCF plan or a documented rationale for why PMCF doesn’t apply; a boilerplate exclusion without device-specific reasoning is treated the same as a missing plan.
Frequently asked
Is “technical file” the same thing as technical documentation under MDR?
In practice, yes — “technical file” is leftover MDD-era terminology that most of the industry still uses informally to mean the Annex II technical documentation dossier. It is not a separate, lower requirement.
Does every device need notified-body review of its technical documentation?
No. Non-sterile Class I devices are self-declared by the manufacturer with no notified-body review at all; sterile or measuring-function Class I devices get a narrow review scoped to that specific aspect. Full technical-documentation review applies from Class IIa upward.
Is the PMS plan part of the technical documentation, or a separate document?
It’s part of it. Article 84 requires the PMS plan as an explicit component of the technical documentation, with its required content set out in Annex III Part A — it isn’t optional paperwork maintained on the side.
Does eSTAR apply to an EU MDR technical documentation submission?
No — eSTAR is an FDA-specific structured submission template used for US 510(k)/De Novo device submissions. The EU has no equivalent structured-template requirement for Annex II technical documentation; dossiers are submitted in whatever format the specific notified body’s process specifies, though EUDAMED’s device-registration modules are gradually taking on more of that role as their rollout continues.
For the broader classification and market-access picture this dossier sits inside, see CASRAI’s Lab Compliance pillar and the EU MDR compliance: what changed from the MDD guide.
