Do I need an IVDR authorised representative if my IVD is class A non-sterile?

Yes. Article 11(1) of Regulation (EU) 2017/746 applies to every device from a manufacturer not established in a Member State, regardless of class. Class A non-sterile devices are self-certified, so no notified body is involved and no transitional deadline ever applied to them — IVDR has governed them since 26 May 2022. The mandate and the Article 28 registration had to be in place from that date.

Can my MDR authorised representative mandate cover my in vitro diagnostic devices?

No. MDR and IVDR are separate regulations with separate Article 11 provisions, separate registration articles and separate documentation cross-references. An MDR mandate refers to Article 56 certificates, Article 10(8) retention and Article 31 registration; an IVD file needs a mandate built on Article 51, Article 10(7) and Article 28. The same company can hold both roles, but two written mandates are required.

When does the IVDR transition period end for class B devices?

31 December 2029, under Article 110(3b)(c) of Regulation (EU) 2017/746 as amended by Regulation (EU) 2024/1860, which also covers class A devices placed on the market in sterile condition. The extension is conditional: a quality management system by 26 May 2025, a formal application lodged with a notified body by 26 May 2027 and a signed written agreement by 26 September 2027.

Does a legacy IVD under the transitional provisions still need EUDAMED registration?

Yes. Article 110(3d) states that the Regulation's requirements on post-market surveillance, market surveillance, vigilance and the registration of economic operators and of devices apply to transitional devices instead of the corresponding Directive 98/79/EC requirements. Registration of economic operators is Article 28, which covers the authorised representative, so the mandate and SRN are needed now, not in 2029.

How long must an IVDR authorised representative keep the technical documentation?

At least ten years after the last device covered by the EU declaration of conformity has been placed on the market, following the period set in Article 10(7) and referenced by Article 11(3)(b). Unlike MDR, IVDR has no fifteen-year variant, because the longer MDR period exists for implantable devices and there are no implantables under IVDR.

Which documents can a competent authority demand from my IVDR authorised representative?

The technical documentation to Annex II and the post-market surveillance documentation to Annex III, the EU declaration of conformity to Annex IV, any Article 51 certificate with its amendments and supplements, the performance evaluation report under Article 56 and Annex XIII, and, for class C and D, the summary of safety and performance under Article 29 and the periodic safety update report under Article 81.

Is the authorised representative liable for a defective IVD?

Article 11(5) makes the authorised representative legally liable for defective devices on the same basis as, and jointly and severally with, the manufacturer where that manufacturer is not established in a Member State and has not complied with Article 10. That liability is why a serious representative insists on seeing the file before signing, and why Article 11(3)(h) requires termination of the mandate when the manufacturer acts contrary to its obligations.

The IVDR Authorised Representative: Article 11 Duties, Documents and Deadlines

7 days ago

7 min read

A manufacturer of in vitro diagnostic medical devices established outside the European Union must appoint an IVDR authorised representative before its devices can be placed on the Union market. Article 11(1) of Regulation (EU) 2017/746 states it without qualification: "Where the manufacturer of a device is not established in a Member State, the device may only be placed on the Union market if the manufacturer designates a sole authorised representative." There is no threshold, no exemption for low-risk IVDs and no grace period for a first shipment. The real questions are narrower: what the mandate must say, which IVD-specific records the representative must hand over, and by which date it must exist for a device still under the transitional provisions.

What the IVDR authorised representative actually is

The representative is a person established in the Union that a non-EU manufacturer appoints in writing to act on its behalf under Regulation (EU) 2017/746. The appointment is a contract, not a notification: "The designation shall constitute the authorised representative's mandate, it shall be valid only when accepted in writing by the authorised representative and shall be effective at least for all devices of the same generic device group." A mandate signed by the manufacturer alone is not a mandate, and one naming a single assay while the manufacturer ships others from the same generic device group is defective on its face.

The role is not the importer's, not the distributor's and not a mailing address. Article 11(5) attaches real exposure: "Without prejudice to paragraph 4 of this Article, 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."

Where IVDR Article 11 differs from MDR Article 11

The two articles are structurally identical: seven paragraphs each, the same eight mandated tasks in points (a) to (h) of paragraph 3, and the same closing duty to walk away — "terminate the mandate if the manufacturer acts contrary to its obligations under this Regulation." Those duties are set out in our post on MDR Article 11. What changes under IVDR is the internal wiring, in three places.

First, the record. IVDR Article 11(3)(b) requires the representative to "keep available a copy of the technical documentation, the EU declaration of conformity and, if applicable, a copy of the relevant certificate, including any amendments and supplements, issued in accordance with Article 51, at the disposal of competent authorities for the period referred to in Article 10(7)". The MDR version of the same point refers to a certificate "issued in accordance with Article 56, at the disposal of competent authorities for the period referred to in Article 10(8)". Article 51 IVDR is the certificates provision, while Article 56 IVDR is performance evaluation. The retention period also differs: Article 10(7) IVDR sets one figure, "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", with no fifteen-year variant, because the MDR's longer period exists for implantables and IVDR has none. IVDR authorised representatives work to one clock, not two.

Second, registration. Under IVDR the representative must "comply with the registration obligations laid down in Article 28 and verify that the manufacturer has complied with the registration obligations laid down in Article 26"; the MDR duty is to "comply with the registration obligations laid down in Article 31 and verify that the manufacturer has complied with the registration obligations laid down in Articles 27 and 29".

Third, the non-delegable obligations. IVDR Article 11(4) reads: "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), (5), (6), (8), (9), (10) and (11)." The MDR equivalent excludes "Article 10(1), (2), (3), (4), (6), (7), (9), (10), (11) and (12)". The lists point at different paragraphs of two differently numbered Article 10s, so an IVD mandate copying MDR numbering cites obligations that do not exist in that form.

The IVDR documents the representative must be able to produce

Article 11(3)(a) requires the representative to verify that the EU declaration of conformity and technical documentation have been drawn up and, where applicable, that an appropriate conformity assessment procedure has been carried out; point (d) requires it to give a competent authority everything needed to demonstrate conformity, in an official Union language that Member State determines. For an IVD that means:

technical documentation to Annex II and post-market surveillance documentation to Annex III;
the EU declaration of conformity with the content required by Annex IV;
the performance evaluation report and its evidence — scientific validity, analytical performance, clinical performance — under Article 56 and Annex XIII;
any certificate issued under Article 51, with its amendments and supplements;
the summary of safety and performance under Article 29, for class C and class D;
the periodic safety update report under Article 81 for class C and class D, or the post-market surveillance report for class A and class B.

The performance evaluation report has no MDR counterpart in the same shape, and class D files may also involve batch verification and an EU reference laboratory.

When the IVDR authorised representative has to be in place

IVDR has applied since 26 May 2022, and for devices that stay self-certified under it — in practice class A non-sterile — nothing was ever deferred. Everything else turns on Article 110, rewritten first by Regulation (EU) 2022/112 and again by Regulation (EU) 2024/1860; the dates below are the ones in force, not the 2017 or 2022 versions.

Article 110(3a) covers devices that held a notified body certificate under the Directive: "Devices which have a certificate that was issued in accordance with Directive 98/79/EC and that is valid by virtue of paragraph 2 of this Article may be placed on the market or put into service until 31 December 2027." Article 110(3b) covers the larger group self-certified under the Directive but now needing a notified body, staged by IVDR class — which class an assay falls into is decided by the Annex VIII rules, explained in our post on IVDR classification.

Device route	Latest date for placing on the market or putting into service	Condition attached
Class A non-sterile, self-certified under IVDR	No transition; IVDR applies since 26 May 2022	Article 11 mandate and Article 28 registration from the outset
Valid Directive 98/79/EC certificate (Art. 110(3a))	31 December 2027	QMS by 26 May 2025; notified body application by 26 May 2025; written agreement by 26 September 2025
Class D, previously self-certified (Art. 110(3b)(a))	31 December 2027	QMS by 26 May 2025; application by 26 May 2025; agreement by 26 September 2025
Class C, previously self-certified (Art. 110(3b)(b))	31 December 2028	QMS by 26 May 2025; application by 26 May 2026; agreement by 26 September 2026
Class B and class A sterile, previously self-certified (Art. 110(3b)(c))	31 December 2029	QMS by 26 May 2025; application by 26 May 2027; agreement by 26 September 2027

Three conditions apply across every row: continued compliance with Directive 98/79/EC, no significant changes in design and intended purpose, and no unacceptable risk. The longest deadline reads, in Article 110(3b), "31 December 2029, for class B devices and for class A devices placed on the market in sterile condition." The application condition is drafted so the representative can act: "the manufacturer or the authorised representative has lodged a formal application with a notified body in accordance with Section 4.3, first subparagraph, of Annex VII for conformity assessment".

Legacy IVDs are not outside the representative and registration rules

The transitional provisions derogate from Article 5, so a legacy device may still be placed on the market, but they do not switch off the modern obligations. Article 110(3d): "By way of derogation from paragraph 3 of this Article, the requirements of this Regulation relating to post-market surveillance, market surveillance, vigilance, and to the registration of economic operators and of devices shall apply to devices referred to in paragraphs 3a and 3b of this Article, instead of the corresponding requirements in Directive 98/79/EC."

Registration of economic operators is Article 28, and the operators registered there include the authorised representative. A manufacturer selling a class B legacy assay under the 2029 deadline therefore needs its mandate and registration today: 2029 is a deadline for the certificate route, not a deferral of Article 11.

EUDAMED actor registration under IVDR Article 28

Article 28 requires manufacturers, authorised representatives and importers to register in the electronic system before a device is placed on the market, and the outcome is the single registration number: "After having verified the data entered pursuant to paragraph 1, the competent authority shall obtain a single registration number ('SRN') from the electronic system referred to in Article 27 and issue it to the manufacturer, the authorised representative or the importer." The validating authority is the one where the representative has its registered place of business — the same authority Article 11(7) redirects every reference in the Regulation towards.

Voluntary use has ended: Commission Decision (EU) 2025/2371 of 26 November 2025 declared the first modules functional, and actor registration, UDI/device registration, notified bodies and certificates, and market surveillance became mandatory from 28 May 2026. Applying for and maintaining the actor record is covered in our post on EUDAMED SRN registration.

An MDR mandate does not cover IVDs

Regulation (EU) 2017/745 and Regulation (EU) 2017/746 are separate instruments with separate Article 11s. A mandate concluded under MDR creates no authority at all for in vitro diagnostics, and a competent authority reviewing an IVD file reads the mandate for its legal basis: if it cites Article 56, Article 10(8) and Article 31, it is an MDR mandate, whatever product names appear in its annex.

A mixed portfolio therefore needs two mandates, even where the same firm acts for both: the generic device groups, the retention clock, the registration articles and the deadlines all differ. Signing a second, IVDR-specific mandate is cheap; discovering during a market surveillance action that your IVDs were never covered is not.

Where Medex fits

Medex Kurumsal Danışmanlık acts as EU authorised representative under both MDR Article 11 and IVDR Article 11, registered in EUDAMED under SRN TR-AR-000057550, with offices in Ankara, İstanbul and Gdańsk and an in-house PRRC supported by a deputy. We hold and produce your documentation, maintain the Article 28 actor record and act as the authority-facing contact — see the EU authorised representative service and the class-based annual fees on our pricing page. We do not perform notified body conformity assessment, we do not write your technical documentation or performance evaluation, and we do not source distributors.