EU IVDR Manufacturer Obligations under Article 10

1. Key takeaways

Article 10 is the skeleton of manufacturer obligations and contains 15 paragraphs. Four are central: Article 10(4) requires the technical documentation to be drawn up and kept up to date (in line with Annexes II and III); Article 10(7) requires the technical documentation, the EU declaration of conformity and copies of certificates to be kept for at least 10 years, counted from the date on which the last device covered by the declaration of conformity was placed on the market; Article 10(8) requires a quality management system covering at least thirteen aspects, (a) to (m); and Article 10(9) requires a post-market surveillance system in accordance with Article 78.

The remaining paragraphs allocate the rest of the compliance perimeter: risk management, declaration of conformity and CE marking, UDI and registration, language duties for accompanying information, corrective action and reporting duties, cooperation with authorities, and financial coverage of liability. Because notified body audits walk the Article 10 list clause by clause, an obligation register mapped to its fifteen paragraphs is the fastest way to present a complete picture at assessment.

2. Legal basis

The table below lists the provisions of Article 10 and the annexes it references.

Articles 78 and 79 and Annex XIII Part B, which define the PMS system the manufacturer must operate, are covered in the dedicated parts of this series on post-market surveillance; the register should cross-reference them.

3. Expert insights

Insight 1: the technical documentation is a living file, not a one-time deliverable.

Article 10(4) uses the wording draw up and keep up to date. Read together with Article 56(6), under which the performance evaluation and the PER must be updated throughout the life cycle using PMPF data, with at least annual updates for Class C and D devices, and with the change management requirement in Article 10(8)(a), the update frequency and intensity of the technical documentation are driven jointly by the risk class and by the rate of change of the product. A documentation plan without scheduled update triggers will drift, and the drift surfaces as nonconformities at the next audit.

Insight 2: the 10-year retention period starts from the last device placed on the market.

Under Article 10(7), the retention period runs from the date on which the last device covered by the EU declaration of conformity was placed on the market, and lasts at least 10 years. Discontinuation therefore does not start the clock; it freezes the countdown until the final placement. Non-EU manufacturers must additionally ensure, under the third subparagraph of Article 10(7), that the authorised representative has permanent availability of the documentation necessary to carry out the tasks under Article 11(3). Retention policy must therefore be defined at system level, with owners, access paths and the authorised representative arrangement all documented.

Insight 3: three of the thirteen QMS aspects are the most frequently underestimated.

Of the aspects listed in Article 10(8), three stand out as additions or intensifications relative to the IVDD: (a) the regulatory compliance strategy and change management procedures, (f) performance evaluation including PMPF, and (i) the establishment, implementation and maintenance of the post-market surveillance system. Manufacturers who simply carry over existing ISO 13485 procedures usually cannot produce evidence for these three items, because the IVDR-specific content, the compliance strategy document, the PMPF plan and the PMS system file, has no direct counterpart in the inherited procedures.

Insight 4: Article 10(15) ties liability risk to financial arrangements.

Manufacturers must, in proportion to the risk class, the type of device and the size of the enterprise, take measures to provide sufficient financial coverage for their potential liability under Directive 85/374/EEC. This paragraph directly shapes the insurance and guarantee arrangements negotiated between non-EU manufacturers and their authorised representatives, and it connects to the joint-liability discussion elsewhere in this series. Financial coverage should be reviewed whenever the portfolio shifts toward higher classes, since the proportional requirement moves with the class mix.

4. Practical recommendations

1. Use the fifteen paragraphs of Article 10 as the table of contents for an obligation-to-evidence-to-owner register, and land each paragraph in practice.
2. Compile the technical documentation as two volumes per Annexes II and III, and define update triggers (changes, PMS data, standard updates).
3. Define the document retention policy at system level: retention period, responsible person, access path, and availability for the non-EU authorised representative.
4. Number the QMS procedure files against the thirteen aspects (a) to (m) one by one, so that notified body auditors can locate them directly.
5. Write the nonconformity handling, notification and cooperation duties of Articles 10(11) to 10(13) as standard operating procedures that have been rehearsed, not merely drafted.

5. Verification checklist

• □ Technical documentation established under Article 10(4) and Annexes II and III, and kept up to date
• □ Retention rule defined: at least 10 years from the last device placed on the market (Article 10(7))
• □ QMS covering the thirteen aspects (a) to (m) of Article 10(8)
• □ Post-market surveillance system in place under Article 10(9) and Article 78
• □ Non-EU manufacturer ensured permanent availability of documents to the authorised representative (third subparagraph of Article 10(7))
• □ Financial coverage of potential liability reviewed (Article 10(15))

Regulatory information verified as of 29 October 2026.

GRZAN builds Article 10 obligation registers, structures IVDR technical documentation to Annexes II and III, and designs QMS procedures that map demonstrably onto the thirteen aspects of Article 10(8) for the EU IVDR market. For tailored compliance support, contact info@grzanglobal.com.