Design and Manufacturing Information in the Technical File

What Section 2 is actually asking for

Section 2 of Annex II — design and manufacturing information — covers a lot of ground. It includes design drawings and schematics, manufacturing processes and quality controls, materials and components, sterilisation where applicable, and supplier information. Read the section heading and it sounds like a folder of engineering documents. In practice, it is more than that: it is the part of the technical file where you demonstrate that your manufacturing process will consistently produce a device that meets its specifications.

That word "consistently" is key. It is not enough to show that one batch met specifications, or that the device as designed would be safe. The documentation needs to give a Notified Body confidence that the process is controlled and repeatable. Teams that treat Section 2 as a document dump — gather the drawings and specifications and move on — end up with a section that looks complete but does not actually demonstrate process control.

The design documentation requirement

Design drawings, schematics, and product specifications are the starting point. These need to cover the device as it is manufactured and sold — not a prototype, not an early development version. If the device went through design iterations before reaching its final form, the documentation trail should show the key decision points and the rationale for the final design.

This is where the concept of a Design History File (DHF) or equivalent becomes relevant. MDR does not mandate the DHF by name, but the combination of requirements in Annex II, Section 2 and the QMS requirements effectively requires the equivalent: a record of how the design evolved, what alternatives were considered and rejected, and why the final design was chosen. For software-containing devices, this includes the software development documentation required by IEC 62304 — architecture documentation, detailed design, unit testing records, and the design rationale for safety-related software functions.

The drawings and specifications in Section 2 also need to be in controlled versions. If the device description in Section 1 says the device is version 4.2, the drawings in Section 2 should correspond to version 4.2. Version misalignment between device description and design documentation is one of the more common internal inconsistencies that auditors find.

Manufacturing process documentation

The manufacturing process section is where teams with complex supply chains or multiple manufacturing sites often have gaps. The requirement is not just to list the manufacturing steps — it is to document how each step is controlled and how those controls ensure the finished device meets its specifications.

For critical manufacturing steps — those where variation could affect device safety or performance — the documentation should show what the acceptance criteria are, how they are verified, and what happens when a step fails verification. If there are in-process controls or 100% inspection points, they should appear here with a reference to the procedure that governs them.

One area that catches teams off guard: sterilisation. If the device is supplied sterile, the sterilisation process needs to be fully documented in Section 2, including the sterilisation method, the validated parameters, the validation data, and the sterility assurance level (SAL). Notified Bodies will pull this documentation and check whether the validation covers the actual packaging configuration and load size used in production — not just a theoretical worst case.

Supplier documentation and critical components

Most devices incorporate components or materials from external suppliers. Section 2 needs to address this — not just by listing suppliers, but by showing how the quality of incoming materials and components is controlled. For critical components (those whose failure or non-conformity could affect device safety or performance), the documentation should show what specifications the component must meet, how incoming inspection or qualification confirms conformity, and what the supplier qualification basis is.

The part that generates findings: supplier documentation that is provided by the supplier but not linked back to how it controls the specific device being manufactured. A Certificate of Conformity from a biocompatible material supplier is not by itself evidence that the material as incorporated in your specific device configuration is biocompatible. The technical file needs to show how the supplier's controls, combined with your design and manufacturing controls, ensure the finished device meets the relevant GSPR.

For contract manufacturing or outsourced manufacturing steps, the technical file needs to show what oversight the manufacturer maintains over the contract manufacturer. If a critical manufacturing step is entirely delegated to a contract manufacturer with no documented manufacturer oversight, that is a gap. MDR is clear that the manufacturer — the legal manufacturer on the label — is accountable for the technical file and for demonstrating that the manufacturing process produces a conforming device.

Multiple manufacturing sites

If the same device (or device variant) is manufactured at more than one site, Section 2 needs to address each site. This does not mean duplicating all the documentation — it means showing that the manufacturing process at each site is equivalent and controlled to the same specifications. If a manufacturing step differs between sites, the technical file should address why the different approach produces equivalent results and which validation data supports that.

Notified Bodies conducting site audits will check whether the technical documentation reflects the actual manufacturing process at the site being audited. A technical file prepared for Site A that references materials, equipment, or process steps that do not exist at Site B, where the audit is happening, is a problem. Site-specific manufacturing information either needs to be in the main technical file or in documented site-specific annexes that are part of the technical file.

Keeping Section 2 current

Section 2 changes whenever the design or manufacturing process changes. This sounds obvious, but in practice Section 2 is often the last part of the technical file to be updated after a design change. The GSPR matrix gets updated because a new test was run; the clinical evaluation is reviewed; but the drawings and specifications in Section 2 are still at the previous version.

The change control process needs to include Section 2 explicitly. When a design change is assessed, the assessment should cover whether the drawings, specifications, or manufacturing process documentation needs to be updated — and the change control record should document the answer. At a surveillance audit, an auditor who finds that the device description says version 4.2 but the manufacturing drawings in Section 2 are still at version 3.1 will ask why, and "we forgot to update them" is not a good answer.