Technical documentation section 3. Design and manufacturing:
3.4 Manufacturing site(s) identification
This section provides identification and details of all manufacturing sites involved in the production of the medical device, including the legal manufacturer and any other economic operators engaged in manufacturing-related activities. The documentation ensures traceability and compliance with MDR requirements.
Legal manufacturer
The legal manufacturer is responsible for the design, manufacture, packaging, and labeling of the device before it is placed on the market under its own name, regardless of whether these operations are carried out by the manufacturer itself or on its behalf.
- Name of the legal manufacturer
- Address (registered business address)
- Contact details
- SRN (single registration number, if available)
Additional manufacturing site(s)
If manufacturing steps such as sterilization, final packaging, or batch release are performed at other sites, those must be clearly identified.
- Site name
- Full address
- Manufacturing activity(ies) performed at the site
- Relationship to legal manufacturer (e.g., subcontractor, in-house)
Quality system coverage
For each site listed, documentation must indicate whether it is covered by the legal manufacturer's QMS or maintains a separate certified QMS. Copies of relevant certificates or evidence of inclusion in the manufacturer’s certificate (e.g., annex to ISO 13485 certificate) should be provided.
Changes and notifications
Changes to the list of manufacturing sites, especially those affecting critical processes, must be controlled through the manufacturer's change control procedure and, where applicable, notified to the notified bodies in accordance with the conformity assessment procedure.
EUDAMED registration
Where applicable, manufacturing sites should be registered in EUDAMED, and their actor roles properly identified according to their function in the supply chain.
