MDR Article 10: Manufacturer Obligations, Paragraph by Paragraph

Article 10 of the MDR sets out the general obligations of every medical device manufacturer: sixteen paragraphs covering design, risk management, clinical evaluation, technical documentation, the EU declaration of conformity, UDI and registration, record keeping, the quality management system, post-market surveillance, labelling language, corrective action, vigilance, cooperation with authorities, subcontractors and liability cover. Since 10 January 2025 a seventeenth obligation sits next to it in Article 10a: advance notice of a supply interruption.

These obligations stay with the manufacturer wherever the manufacturer is based. A manufacturer outside the Union appoints an EU authorised representative, but Article 11(4) lists ten Article 10 paragraphs that the mandate cannot delegate. This guide goes through each paragraph, quotes the text where the wording matters and shows where the authorised representative comes in.

What does MDR Article 10 require?

The table gives one line per paragraph. The last column shows whether Article 11(4) excludes the paragraph from the authorised representative's mandate.

Paragraph	Obligation	Excluded from the mandate by Article 11(4)
10(1)	Design and manufacture in accordance with the Regulation	Yes
10(2)	Risk management system (Annex I, Section 3)	Yes
10(3)	Clinical evaluation including PMCF (Article 61, Annex XIV)	Yes
10(4)	Technical documentation (Annexes II and III)	Yes
10(5)	Documentation for custom-made devices (Annex XIII)	No
10(6)	EU declaration of conformity and CE marking	Yes
10(7)	UDI system and registration (Articles 27, 29, 31)	Yes
10(8)	Keep documents for 10 years, 15 for implantable devices	No
10(9)	Quality management system	Yes
10(10)	Post-market surveillance system (Article 83)	Yes
10(11)	Annex I, Section 23 information in the required language	Yes
10(12)	Corrective action, withdrawal or recall	Yes
10(13)	Incident and FSCA recording and reporting (Articles 87, 88)	No
10(14)	Information, documentation and samples for competent authorities	No
10(15)	Identity of the person designing or manufacturing the device	No
10(16)	Financial coverage for liability	No
10a	Notice of an interruption or discontinuation of supply	Not listed (added in 2024)

"No" in the last column does not mean the authorised representative takes the obligation over. It means the paragraph is not on the Article 11(4) list. The manufacturer still has to meet it, and the authorised representative's own tasks are the ones in Article 11(3).

Design, risk and clinical evidence: paragraphs 1 to 5

Paragraph 1 is the general rule: manufacturers "shall ensure that they have been designed and manufactured in accordance with the requirements of this Regulation." Paragraphs 2 to 5 name the evidence that shows it.

Risk management is a continuing system, not a one-off report: "Manufacturers shall establish, document, implement and maintain a system for risk management as described in Section 3 of Annex I."

Clinical evaluation applies to every class, including class I: "Manufacturers shall conduct a clinical evaluation in accordance with the requirements set out in Article 61 and Annex XIV, including a PMCF." We cover the method in clinical evaluation under MDR Article 61 and the follow-up in PMCF plan and report.

The technical documentation has to stand on its own: "The technical documentation shall be such as to allow the conformity of the device with the requirements of this Regulation to be assessed." The content is set by Annexes II and III; see MDR technical documentation. Custom-made devices follow paragraph 5 and Annex XIII instead, covered in custom-made devices.

Declaration of conformity, UDI and registration: paragraphs 6 and 7

Once the conformity assessment is complete, manufacturers "shall draw up an EU declaration of conformity in accordance with Article 19, and affix the CE marking of conformity in accordance with Article 20." What the declaration must contain is set out in EU declaration of conformity.

Paragraph 7 ties the manufacturer to EUDAMED: "Manufacturers shall comply with the obligations relating to the UDI system referred to in Article 27 and with the registration obligations referred to in Articles 29 and 31." Article 31 is actor registration and the SRN, Article 29 is device registration with the Basic UDI-DI. See EUDAMED registration and the SRN and Basic UDI-DI.

How long must documents be kept? Paragraph 8

The retention period runs from the last device, not the first: documents are kept "for a period of at least 10 years after the last device covered by the EU declaration of conformity has been placed on the market. In the case of implantable devices, the period shall be at least 15 years after the last device has been placed on the market."

Paragraph 8 also contains the sentence that matters most for manufacturers outside the Union: "A manufacturer with a registered place of business outside the Union shall, in order to allow its authorised representative to fulfil the tasks mentioned in Article 11(3), ensure that the authorised representative has the necessary documentation permanently available." In practice this means a current copy, or secure access to one, held by your authorised representative for the whole retention period, not a promise to send the file when an authority asks.

Quality management system: paragraph 9

Paragraph 9 requires manufacturers to "establish, document, implement, maintain, keep up to date and continually improve a quality management system", proportionate to the risk class and type of device, and lists thirteen aspects it must address at least. Class I manufacturers are not exempt. We go through the thirteen aspects in MDR Article 10(9) and the quality management system.

After the device is on the market: paragraphs 10, 12 and 13

Paragraph 10 requires a post-market surveillance system under Article 83 (see post-market surveillance under the MDR). Paragraph 13 requires "a system for recording and reporting of incidents and field safety corrective actions as described in Articles 87 and 88." Reporting timelines are in serious incident reporting.

Paragraph 12 deals with non-conforming devices. Manufacturers "shall immediately take the necessary corrective action to bring that device into conformity, to withdraw it or to recall it, as appropriate. They shall inform the distributors of the device in question and, where applicable, the authorised representative and importers accordingly." Where the device presents a serious risk, the competent authorities and, where applicable, the notified body are informed immediately as well.

Labelling language: paragraph 11

The information in Annex I, Section 23 has to reach the user in the right language: "in an official Union language(s) determined by the Member State in which the device is made available to the user or patient. The particulars on the label shall be indelible, easily legible and clearly comprehensible to the intended user or patient." Member State language rules are summarised in label language requirements.

Requests from competent authorities: paragraph 14

Manufacturers "shall, upon request by a competent authority, provide it with all the information and documentation necessary to demonstrate the conformity of the device, in an official Union language determined by the Member State concerned." The competent authority of the Member State where the manufacturer has its registered place of business may also require samples free of charge. For a manufacturer outside the Union, the request usually arrives through the authorised representative under Article 11(3)(d) and (e); how that works is explained in competent authority requests.

Subcontractors and liability cover: paragraphs 15 and 16

If another person designs or manufactures the device for you, paragraph 15 makes that person's identity part of the actor information submitted under Article 30(1). Paragraph 16 requires financial cover: manufacturers "shall, in a manner that is proportionate to the risk class, type of device and the size of the enterprise, have measures in place to provide sufficient financial coverage in respect of their potential liability under Directive 85/374/EEC".

Article 10a: notice of a supply interruption

Regulation (EU) 2024/1860 inserted Article 10a, applicable from 10 January 2025. Where a manufacturer anticipates an interruption or discontinuation of supply of a device other than a custom-made device, and "it is reasonably foreseeable that such interruption or discontinuation could result in serious harm or a risk of serious harm to patients or public health in one or more Member States", the manufacturer informs the competent authority and the economic operators, health institutions and healthcare professionals it supplies directly.

The timing is fixed: "The information referred to in the first subparagraph shall, other than in exceptional circumstances, be provided at least 6 months before the anticipated interruption or discontinuation." Article 120(13) applies Article 10a to legacy devices placed on the market under Article 120(3a) and (3b) as well.

What Article 10 means for the authorised representative

Article 11(4) draws the line: "The mandate referred to in paragraph 3 of this Article shall not delegate the manufacturer's obligations laid down in Article 10(1), (2), (3), (4), (6), (7), (9), (10), (11) and (12)."

Article 11(5) then links the authorised representative's liability to Article 10: "where the manufacturer is not established in a Member State and has not complied with the obligations laid down in Article 10, the authorised representative shall be legally liable for defective devices on the same basis as, and jointly and severally with, the manufacturer." This is why an authorised representative reads the declaration of conformity and the technical documentation before accepting a mandate, as Article 11(3)(a) requires, and why gaps in Article 10 compliance come up at that stage. The full list of tasks is in MDR Article 11 and the liability side in authorised representative liability.

Frequently asked questions

Does MDR Article 10 apply to class I devices?

Yes. Article 10 applies to manufacturers of all classes. Class I manufacturers also need risk management, clinical evaluation, technical documentation, a quality management system and post-market surveillance, proportionate to the device.

Can an EU authorised representative take over the manufacturer's obligations?

No. Article 11(4) excludes paragraphs 1, 2, 3, 4, 6, 7, 9, 10, 11 and 12 of Article 10 from the mandate. The authorised representative performs the tasks in Article 11(3).

How long must technical documentation be kept under the MDR?

At least 10 years after the last device covered by the EU declaration of conformity has been placed on the market, and at least 15 years for implantable devices (Article 10(8)).

What is MDR Article 10a?

It is the obligation, applicable since 10 January 2025, to give at least 6 months' notice of an anticipated interruption or discontinuation of supply where it could result in serious harm or a risk of serious harm to patients or public health.

Sources

Regulation (EU) 2017/745, consolidated text on EUR-Lex (CELEX 02017R0745-20261109), Articles 10, 10a, 11 and 120. The quoted wording is identical in the 10.01.2025 consolidation.

Regulation (EU) 2024/1860 of 13 June 2024, Article 1(1) and Article 3 (Official Journal L, 9.7.2024)

Medex Kurumsal as your EU authorised representative

Medex Kurumsal Danışmanlık acts as EU authorised representative under MDR 2017/745 and IVDR 2017/746, registered in EUDAMED under SRN TR-AR-000057550. Before we accept a mandate we check the EU declaration of conformity and the technical documentation against Article 10, so that gaps are found before the device reaches the market.

Our rates are published on the EU authorised representative cost page. To start, send the device list and the declaration of conformity through request a proposal.

Who wrote this

Medex is an authorised representative established in Ankara and registered in EUDAMED under SRN TR-AR-000057550.