EU Authorized Representative for Sri Lanka: From an NMRA Local Agent to MDR Article 11

NMRA already classifies devices the EU way

Most regulators outside Europe run their own risk classes and leave manufacturers to translate them. The NMRA does not. Its guideline for low-risk devices, GL-037 of May 2026, states:

"The classification of General medical devices and IVDDs shall follow the principles and rules outlined in the guidelines for classification of medical devices and IVDDs under the European Union (EU) Medical Device Regulations." (NMRA GL-037, Section 5)

The same guideline names the higher classes in EU terms, excluding from its scope general medical devices that fall "under Class II a, II b, III as per EU Classification" and IVDs in "Class B, Class C and Class D as per EU Classification" (GL-037, Section 6). It also tells applicants to read it together with MDCG 2021-24, the Commission's classification guidance.

The MDR rule itself is short:

"Devices shall be divided into classes I, IIa, IIb and III, taking into account the intended purpose of the devices and their inherent risks. Classification shall be carried out in accordance with Annex VIII." (MDR Article 51(1))

A classification that holds up in Colombo is a good starting point for Europe. It is still a starting point. In the Union the notified body reviews your classification as part of conformity assessment, and a disagreement at that stage changes the procedure, the fee and the timeline.

Reliance on the EU runs into Sri Lanka only

The NMRA's consolidated dossier guideline, GL-034 of July 2025, sets a reliance pathway. For general medical devices, registrations from "USA, UK, Australia, Canada, Japan, Norway, Switzerland & All European Union (EU) member countries" are considered; for IVDs the list adds Singapore (GL-034, Section 7).

CE marking therefore shortens the path into Sri Lanka. The Union keeps no reciprocal list, and an NMRA registration certificate has no standing in conformity assessment under the MDR.

Local agent and EU authorised representative

A foreign manufacturer reaches the NMRA through a local agent. GL-034 makes a "Letter of Authorization (LOA) from the legal manufacturer" mandatory and requires the local agent's business registration for site applications (GL-034, Sections 8.2 and 8.4). The applicant, "whether a manufacturer or importer", confirms responsibility for the safety, quality and effectiveness of the registered device (GL-034, Section 6).

The EU role is defined differently:

"‘authorised representative’ means any natural or legal person established within the Union who has received and accepted a written mandate from a manufacturer, located outside the Union, to act on the manufacturer's behalf in relation to specified tasks with regard to the latter's obligations under this Regulation;" (MDR Article 2(32))

The Sri Lankan local agent is often also your importer and distributor. The EU authorised representative has none of those commercial functions by default. It holds documents, cooperates with competent authorities, verifies registration and forwards complaints, and it shares liability with you under Article 11(5). Keeping that role separate from your European distributors lets you change distributors without touching your EUDAMED registration.

Documents you already have, and what the EU still needs

A Sri Lankan dossier built for the NMRA contains much of the evidence Europe asks for. GL-034 lists a risk analysis report to ISO 14971, sterilisation validation, biological evaluation, electrical safety and EMC data, software verification and validation, a clinical evaluation report where applicable and ISO 13485 certification (GL-034, Section 8.4). It also lists a "Summary Technical Documentation (STED)" and an "Essential Requirement Check list" prepared to GHTF guidelines.

The MDR asks for more structure and more depth. Technical documentation follows Annexes II and III, the checklist becomes a demonstration of conformity with the general safety and performance requirements in Annex I, and clinical evaluation follows Article 61 and Annex XIV. A STED is a useful draft of that file, not a substitute for it.

Getting the Union side in place from Colombo

Medex Kurumsal Danışmanlık is established in Türkiye. The European Commission's Notice to Stakeholders of March 2022 states that manufacturers established outside the territory of the EU or Turkey "only need to designate one authorised representative, either in the EU or in Turkey, in order to place medical devices on the market in the EU or in Turkey." Switzerland, Great Britain and the EEA-EFTA states require their own local representatives; Medex does not act for those markets.

The steps on our side:

1. Written mandate under Article 11(3). It records the minimum tasks, including verifying that the declaration of conformity and technical documentation exist and keeping copies available to competent authorities.

2. EUDAMED actor registration. Your company registers as manufacturer and receives its Single Registration Number, linked to our authorised representative SRN TR-AR-000057550.

3. UDI. Basic UDI-DI and UDI-DI data are registered for each device before it is placed on the market.

4. Person responsible for regulatory compliance. Medex's PRRC is in-house, as the Regulation requires:

"Authorised representatives shall have permanently and continuously at their disposal at least one person responsible for regulatory compliance who possesses the requisite expertise regarding the regulatory requirements for medical devices in the Union." (MDR Article 15(6))

5. Label and IFU address. Annex I, Section 23.2(d) requires our name and registered address on the label of a device whose manufacturer is established outside the Union. The Sinhala and Tamil patient leaflets the NMRA asks for do not cover EU language requirements; each Member State sets its own under Article 10(11).

Medex works from Ankara, İstanbul and Gdańsk. We do not write technical documentation, we are not a notified body, and we do not find distributors. Annual fees are published on our pricing page, from €800 for class I to €2,000 for class III, with no setup fee and €150 for a change of representative.

Related country and guidance pages

Manufacturers in neighbouring markets face similar questions; we keep separate pages for India, Bangladesh and Pakistan. The full list of countries is on the EU authorized representative by country page, and the obligations behind the mandate are set out in our EU authorized representative guide.

Frequently asked questions

NMRA already classified our device under EU rules. Do we need to classify it again?

You need to document the classification under MDR Annex VIII in your technical documentation, and for classes IIa to III the notified body will review it. If the NMRA classification was done correctly, the result should match, but the notified body's view decides in the Union.

Sri Lanka accepts EU registrations through reliance. Will the EU accept an NMRA registration?

No. The reliance pathway in NMRA guideline GL-034 is a Sri Lankan import rule. The Union does not rely on NMRA decisions, and conformity must be demonstrated under the MDR.

Can our Sri Lankan local agent act as our EU authorised representative?

No. The MDR requires the authorised representative to be established within the Union; the Commission's 2022 notice extends this to Türkiye under the Customs Union. A company established only in Sri Lanka cannot accept the mandate.

Does a Türkiye-based representative cover the whole EU?

Yes. The Commission's March 2022 notice confirms that manufacturers outside the EU and Turkey need only one authorised representative, either in the EU or in Turkey, to place devices on the market in the EU. Switzerland, Great Britain and the EEA-EFTA states require their own local representatives.

Sources

National Medicines Regulatory Authority — GL-037, Guideline for Application Submission and Processing of Listed Devices, Class I General Medical Devices and Class A IVDs (May 2026) — cdn.prod.website-files.com

National Medicines Regulatory Authority — GL-034, Guideline for Consolidated Dossier New Application Submission and Evaluation (July 2025) — cdn.prod.website-files.com

Regulation (EU) 2017/745 on medical devices, consolidated text — eur-lex.europa.eu

MDCG 2021-24 Rev.1, Guidance on classification of medical devices — health.ec.europa.eu

European Commission — Notice to Stakeholders: EU-Turkey Customs Union Agreement in the field of medical devices (March 2022) — health.ec.europa.eu

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Related guides

Before you appoint anyone, our EU authorized representative guide explains the role and what a mandate covers, the EU authorized representative cost guide shows what the fee should include, and the buyer's checklist helps you compare providers. The contract itself is covered in our note on the mandate agreement under Article 11(3). When you are ready, you can request a proposal.

Other countries we cover

We act as EU authorized representative for manufacturers in many markets. See the pages for India, Pakistan, Bangladesh, the United States, China and the United Kingdom, or browse the full list by country and the list by device category.

If your devices still need to be registered in EUDAMED, see our EUDAMED registration proposal.