IVDR Article 16: When Distributors and Importers Become the Manufacturer

1. Key takeaways

Article 16(1) provides that distributors, importers or other natural or legal persons assume the obligations of the manufacturer if they carry out any of three acts: making a device available under their own name or registered trademark (unless agreed otherwise with the manufacturer, the manufacturer is identified as manufacturer on the label and assumes the manufacturer obligations); changing the intended purpose of a device already placed on the market or put into service; or modifying a device in a way that may affect conformity with the applicable requirements. Translation and repackaging benefit from a conditional exception, subject to 28 days in advance notification and a quality management system certificate (Articles 16(2)–(4)). The provision is one of the most consequential status rules in the IVDR for commercial teams, because it can convert a routine sales or marketing decision into full manufacturer liability, including technical documentation, performance evaluation, the quality management system and post-market surveillance duties.

2. Legal basis

3. Expert insights

Insight 1: Labelling under your own brand means deemed-manufacturer status as the rule; the only way out is the manufacturer identified on the label.

The proviso of Article 16(1)(a) requires that the distributor or importer agrees with the manufacturer that the latter is identified as manufacturer on the label and assumes the responsibilities imposed on manufacturers by the Regulation. A manufacturer name buried on the inside of the packaging or in small print is generally insufficient; the identification must be recognisable at the label level. Businesses running private-label programmes should therefore audit the actual label artwork, not just the contract text: if the physical label does not visibly identify the original manufacturer as manufacturer, the private-label party carries the entire Article 10 obligation set even though a commercial agreement exists behind the scenes.

Insight 2: Changing the intended purpose is the highest-risk trigger act.

Article 16(1)(b) targets changes to the intended purpose of devices already placed on the market or put into service. Typical cases are new indications, new sample types or new testing scenarios added to instructions for use or marketing materials. Such changes are frequently initiated by marketing teams, yet they directly convert the actor into the manufacturer with the full obligation set: technical documentation, performance evaluation, the quality management system and post-market surveillance. Because the change happens on paper rather than on the device, it is also the easiest trigger to commit unintentionally, which is why intended-purpose changes should never be decided outside a regulatory review.

Insight 3: Translation and repackaging form a conditional safe harbour.

Article 16(2)(a) excludes from the notion of modifying a device the supply, including translation, of manufacturer information in accordance with Annex I Section 20, together with additional information necessary for sale in the relevant Member State. Article 16(2)(b) likewise excludes changes to the outer packaging, including changes of pack size, provided the repackaging is necessary to place the device on the market of that Member State and the conditions of implementation do not adversely affect the original condition of the device. For sterile devices, the final sentence of Article 16(2)(b) sets a presumption: where the packaging necessary to maintain sterility has been opened, damaged or otherwise adversely affected, the original condition is presumed to have been adversely affected. Businesses relying on the safe harbour must document necessity, process control and, for sterile products, packaging integrity management.

Insight 4: Using the safe harbour still carries a compliance cost.

Article 16(3) requires distributors and importers performing translation or repackaging to indicate on the device or packaging, or in the accompanying documents, that the activity was carried out together with their name, trademark, registered place of business and contact address; and to have a quality management system with procedures ensuring that the translation is accurate and up to date, the activity is performed under conditions preserving the original condition of the device, and repackaged devices are not defective, of inferior quality or unclean. Article 16(4) requires notification of the manufacturer and the competent authority of the Member State concerned at least 28 days before the relabelled or repackaged devices are made available, provision of samples or dummy devices on request (including translated labels and instructions for use), and, within the same 28-day period, submission to the competent authority of a quality management system certificate issued by a notified body with competence for the relevant device type.

4. Practical recommendations

1. Assess any private-labelling request against Article 16(1)(a) first: is the manufacturer identified as manufacturer on the label and does it assume the obligations?
2. Route any addition of indications or sample types in marketing materials and instructions for use through an intended-purpose change assessment (Article 16(1)(b)).
3. Build a standard workflow for translation and repackaging under Articles 16(2)–(4): identification, quality management system, notified body certificate, 28-day notification.
4. Run a separate original-condition risk assessment for repackaging of sterile products, avoiding the presumption of Article 16(2)(b).
5. Embed the Article 16 assessment into the sales and commercial review process rather than remediating it afterwards in the regulatory department.

5. Verification checklist

• □ Proviso of Article 16(1)(a) assessed for private-labelling requests
• □ Intended-purpose changes routed through an assessment (Article 16(1)(b))
• □ Modification acts assessed for conformity impact (Article 16(1)(c))
• □ Identification and quality management system established for translation and repackaging (Article 16(3))
• □ Notified-body quality management system certificate obtained (Article 16(4))
• □ Manufacturer and competent authority notified 28 days in advance with samples prepared (Article 16(4))

Legal information verified as of 2026-10-29.

GRZAN supports in vitro diagnostic manufacturers entering the EU market under Regulation (EU) 2017/746 as EU Authorised Representative (EC REP) and PRRC provider, including Article 16 status assessments, safe-harbour workflows for translation and repackaging, EUDAMED registration support and fee budgeting. For deemed-manufacturer risk reviews, contact info@grzanglobal.com.