Fractio · Guide for Nordic buyers

MDR, CE marking and ISO 13485: what a buyer of medical and dental consumables needs to know

Buying consumables from a Portuguese manufacturer puts you inside the EU Medical Device Regulation as a distributor — or, if your own brand goes on the box, as the manufacturer. This guide explains the roles, the checks, the classes that matter for consumables, the 2027–2028 legacy deadlines, EUDAMED, INFARMED and what to ask for before a first order.

Miguel Baptista · Fractio · Gothenburg. Commercial experience in MedTech in Portugal and previous roles at P&G and L’Oréal.
Published on 12 October 2026

Three roles, and which one you are

The EU Medical Device Regulation (Regulation (EU) 2017/745, “MDR”) assigns obligations by role. The manufacturer is whoever places a device on the market under its own name or trademark; it owns the technical documentation, the EU Declaration of Conformity, the UDI, the quality system and post-market surveillance (Articles 2 and 10). An importer is an EU-based company that brings a device from outside the EU. A distributor is anyone else in the chain who makes a device available (Article 14) — see the consolidated text on EUR-Lex.

A Nordic company buying consumables from a Portuguese manufacturer is a distributor, not an importer: Portugal is in the EU, so there is no import. That matters because the distributor’s duties are lighter — verification, record-keeping, cooperation with authorities — but they are real, and in 2026 the Court of Justice clarified how far they go.

What a distributor must check before selling

Article 14 lists the checks a distributor makes before making a device available:

the device carries the CE marking and an EU Declaration of Conformity has been drawn up;
the device is accompanied by the information the manufacturer must supply (label, instructions for use, in the languages required by the country of sale);
for devices from outside the EU, that the importer has met its own obligations (not applicable to Portuguese-made devices);
a UDI has been assigned where applicable.

In its June 2026 judgment in case C-10/24 (Dürr Dental) the Court of Justice held that a distributor must verify the existence of the CE marking and the Declaration of Conformity, not re-assess their substance or re-classify the device — but where the manufacturer’s documents show a class that requires a notified body, the distributor must check that the CE mark carries the notified body’s four-digit number (Taylor Wessing summary). Keep a register of complaints, non-conforming devices, recalls and withdrawals, and do not supply a device you have reason to believe is non-compliant.

Private label: the point where a buyer becomes the manufacturer

Article 16 is the clause most relevant to a Nordic brand sourcing consumables. If you make a device available under your own name or trademark, you become the manufacturer with all its obligations — unless a written agreement keeps the original manufacturer identified on the label and responsible for MDR compliance. The same applies if you change the intended purpose or modify the device. Translating labels, repackaging or relabelling is allowed under Article 16(2)–(4) with a certified quality system for those activities and 28 days’ notice to the manufacturer and the authority (Article 16 text; guidance in MDCG 2021-26).

In practice there are two clean models. Either the Portuguese company stays the legal manufacturer and your brand appears alongside it under a written agreement, and you remain a distributor; or your brand appears alone, in which case you need your own single registration number in EUDAMED, your own Basic UDI-DI, your own technical documentation and conformity assessment, and your own post-market surveillance. Decide this before the quotation, because it changes who pays for what.

Classes that matter for consumables

Classification follows Annex VIII. The dental industry association FIDE publishes a worked list for dental products based on the Commission’s MDCG 2021-24 guidance (FIDE classification list); MDCG 2021-24 itself was revised in April 2026, so check the current examples before relying on a class.

Indicative classes for common consumables; confirm against the manufacturer’s Declaration of Conformity and current MDCG guidance.
Product	Typical class	Notified body?
Dental impression material (no nanomaterial), impression trays, prophylaxis powders	I	No — manufacturer self-declares
Examination gloves, non-sterile	I	No
Impression material with nanomaterial or for damaged mucosa	IIa	Yes
Single-use sterile dental syringes; sterile single-use consumables generally	Is / IIa	Yes (sterility aspects at minimum)
Filling materials, cements, bonders, crowns	IIa	Yes
Sterile surgical gloves	Is	Yes (sterility)

The practical consequence: a class I non-sterile product can be CE-marked by the manufacturer alone, so the Declaration of Conformity and the technical file are the whole story. Anything sterile, with a measuring function, or class IIa and above needs a notified body certificate — ask for it, check the body’s number on the CE mark and look it up in the NANDO database.

Legacy certificates and the 2027–2028 deadlines

Many Portuguese consumables are still sold under certificates issued under the old Directive (MDD). Regulation (EU) 2023/607 extended their validity: to 31 December 2027 for class III and implantable class IIb devices, and to 31 December 2028 for other class IIb, IIa, Is and Im devices — provided the manufacturer has an MDR-compliant quality system, lodged an application with a notified body by 26 May 2024 and signed an agreement by 26 September 2024, and has made no significant changes (HPRA summary of the transitional provisions). The former “sell-off” deadline was removed, so legally placed devices can continue to be supplied.

For a buyer this means a supplier may legitimately ship a class IIa consumable under an MDD certificate until the end of 2028. Ask for evidence of the transition — the notified body’s confirmation letter or signed agreement — and ask when the MDR certificate is expected. A supplier that cannot answer is a supply-continuity risk, whatever the price.

EUDAMED: what changed in May 2026

Four EUDAMED modules became mandatory on 28 May 2026 — actor registration, UDI/device registration, notified bodies and certificates, and market surveillance — following Commission Decision (EU) 2025/2371 (summary). Manufacturers must register devices already on the market in the UDI module by 27 November 2026; notified bodies upload existing certificates by 28 May 2027. Vigilance and clinical-investigation modules were not yet mandatory in mid-2026.

What it gives you: a public database in which you can look up the manufacturer’s single registration number (format PT-MF-000000000 for a Portuguese manufacturer), its devices and the certificates behind them. Distributors do not register in EUDAMED and have no SRN; Member States may still require national registration.

INFARMED and the Portuguese side

INFARMED is Portugal’s competent authority for medical devices under Decreto-Lei 29/2024, which executes the MDR nationally and was effective from July 2024 (Garrigues; DLA Piper). It supervises notified bodies, runs inspections, handles vigilance and recalls, and operates SIDM, the national device-information system in which manufacturers and wholesale distributors notify devices placed on the Portuguese market. Law firms expect some national registration duties to lapse now that EUDAMED is mandatory; INFARMED guidance is the reference.

For a buyer, INFARMED matters in two ways: its public device search is a second place to check that a Portuguese manufacturer and its devices are registered, and its inspection and vigilance record is where problems would surface.

ISO 13485 and the quality side

ISO 13485:2016 is the quality-management standard for medical devices and the one notified bodies audit against. It is not a legal requirement in itself, but a manufacturer without it will struggle to obtain or keep an MDR certificate for anything above class I, and even for class I it is the simplest evidence that the quality system is real. Certificates run on a three-year cycle with annual surveillance audits.

Check two things: that the certificate scope covers the products you want to buy (a scope limited to “distribution” or to another product family is a red flag), and that it carries an accreditation mark — IPAC in Portugal, or a foreign body such as UKAS or DAkkS — and can be found on the certification body’s online register (IPAC).

What to ask a Portuguese consumables manufacturer for

EU Declaration of Conformity for each device or device family: manufacturer name and SRN, device name and Basic UDI-DI, risk class and rule, conformity-assessment route, notified body and certificate number where applicable, harmonised standards applied, signature and date.
Notified body certificate (quality-system and, where relevant, technical-documentation assessment) for class Is/Im/Ir, IIa, IIb, III — or the MDD certificate plus evidence of the MDR transition.
ISO 13485 certificate with scope, certification body, accreditation mark and expiry.
UDI: UDI-DI and UDI-PI on label and packaging; Basic UDI-DI in the Declaration.
Labelling and IFU in the languages your market requires; Sweden requires Swedish for devices intended for lay users — confirm the current rule with Läkemedelsverket.
Private-label agreement stating who the legal manufacturer is and what appears on the label.
Supply documentation: certificates of analysis or conformity per lot, sterilisation records where applicable, shelf life, and the manufacturer’s vigilance and recall procedure.
Retention: as a distributor or importer in Sweden you should be able to produce the Declaration and the notified body certificate for at least ten years after the last unit was placed on the market (Läkemedelsverket).

Swedish specifics

Läkemedelsverket (the Swedish Medical Products Agency) is the competent authority; the Swedish framework is Lag (2021:600) and Förordning (2021:631) with the agency’s regulations HSLF-FS 2021:32 as amended. Registration and annual fees apply to manufacturers and authorised representatives established in Sweden; we found no national registration requirement for distributors, but the agency asks importers and distributors to notify it in certain situations and runs risk-based surveillance of online sellers (agency page). If you sell into Norway, note that the Norwegian Medical Products Agency requires national registration of distributors; Finland’s Fimea publishes its own distributor guidance.

A short buyer checklist

Decide the brand model (manufacturer’s brand, co-branding under agreement, or your brand) before the RFQ.
Ask for the Declaration of Conformity, the notified body certificate where applicable and the ISO 13485 certificate with scope — and verify each one in EUDAMED, NANDO and the certification body’s register.
For legacy certificates, ask for the MDR transition evidence and the expected certification date.
Confirm the languages on label and IFU for every Nordic market you serve.
Set up your distributor register (complaints, non-conformities, recalls) before the first delivery, not after the first problem.

Where Portuguese consumables manufacturers are, and which clusters they draw on, is covered in the sourcing map; the commercial side of a search is on the enquiry page for healthcare, dental and veterinary products.

This guide is general information, not legal or regulatory advice. Regulations and guidance change; confirm the current text with the Commission, INFARMED or Läkemedelsverket, and involve your regulatory affairs specialist before a first order.

Sources

Figures are quoted as published by the sources below, with their reference year. They describe the sector, not any individual company; capabilities and capacity are confirmed per project.

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Fractio helps Nordic buyers search for manufacturers in Portugal and coordinates quotations, samples and follow-up from Gothenburg. Scope, responsibilities and remuneration are agreed before work starts; an enquiry is not an order.

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