EU MDR (Regulation 2017/745): is it a medical device, and what you must check before you sell it

Regulation (EU) 2017/745Regulation (EU) 2017/745, Medical Devices Regulation (consolidated text of 19 July 2026)The whole regulationClick opens the law on the EU Publications Office., the Medical Device Regulation or MDR, settles two things for anyone selling into the EU: whether your product is a medical device at all, and which role you hold when you sell it. A back brace, a clinical thermometer, a box of plasters and a massager sold to relieve pain can all be medical devices. The same massager sold for relaxation is not. Once a product is a device, the duties follow your role: manufacturer, importer or distributor.

Whether your product is a medical device under the EU MDR

The definition turns on purpose. A medical device is any “instrument, apparatus, appliance, software, implant, reagent, material or other article intended by the manufacturer to be used, alone or in combination, for human beings” for one of the listed medical purposes (Art. 2(1)Regulation (EU) 2017/745, Medical Devices Regulation (consolidated text of 19 July 2026)Article 2, point 1Click opens the article on EUR-Lex.). The intended purpose is the use stated by the manufacturer “on the label, in the instructions for use or in promotional or sales materials or statements and as specified by the manufacturer in the clinical evaluation” (Art. 2(12)Regulation (EU) 2017/745, Medical Devices Regulation (consolidated text of 19 July 2026)Article 2, point 12Click opens the article on EUR-Lex.).

The Court of Justice added a second test on 2 July 2026. The manufacturer’s data are an important element, but not the only one: a product must also objectively perform one of the medical functions of the definition, and general sales information that is “merely useful in nature” does not decide the purpose. Blank patient wristbands sold to hospitals were therefore not medical devices, whatever their maker’s brochure said about medical errors (Case C-427/24, Diagramm Halbach, paragraphs 22, 28 and 29).

For the products online sellers meet most:

A product with both a medical and a non-medical purpose meets both sets of rules (Art. 1(3)Regulation (EU) 2017/745, Medical Devices Regulation (consolidated text of 19 July 2026)Article 1, paragraph 3Click opens the article on EUR-Lex.). A product that is not a medical device still falls under the General Product Safety Regulation and, if it is electrical, under the laws in CE marking.

Which role you hold

The own-brand rule is the one that catches online sellers. A support bought from a factory and sold under your brand makes you the manufacturer, with every duty below. The one way out is an agreement with the real manufacturer under which it is named as manufacturer on the label and carries the manufacturer’s duties (Art. 16(1)(a)Regulation (EU) 2017/745, Medical Devices Regulation (consolidated text of 19 July 2026)Article 16, paragraph 1, point (a)Click opens the article on EUR-Lex.).

What the manufacturer must have in place

Whoever is the manufacturer, whether the factory or an own-brand seller, carries these duties:

• a risk management system and a clinical evaluation (Art. 10(2)Regulation (EU) 2017/745, Medical Devices Regulation (consolidated text of 19 July 2026)Article 10, paragraph 2Click opens the article on EUR-Lex., Art. 10(3)Regulation (EU) 2017/745, Medical Devices Regulation (consolidated text of 19 July 2026)Article 10, paragraph 3Click opens the article on EUR-Lex.);
• technical documentation to Annexes II and III (Art. 10(4)Regulation (EU) 2017/745, Medical Devices Regulation (consolidated text of 19 July 2026)Article 10, paragraph 4Click opens the article on EUR-Lex.);
• a quality management system proportionate to the class and type of device (Art. 10(9)Regulation (EU) 2017/745, Medical Devices Regulation (consolidated text of 19 July 2026)Article 10, paragraph 9Click opens the article on EUR-Lex.);
• the conformity assessment for the class, then the EU declaration of conformity and the CE marking (Art. 10(6)Regulation (EU) 2017/745, Medical Devices Regulation (consolidated text of 19 July 2026)Article 10, paragraph 6Click opens the article on EUR-Lex., Art. 19(1)Regulation (EU) 2017/745, Medical Devices Regulation (consolidated text of 19 July 2026)Article 19, paragraph 1Click opens the article on EUR-Lex., Art. 20Regulation (EU) 2017/745, Medical Devices Regulation (consolidated text of 19 July 2026)Article 20Click opens the article on EUR-Lex.);
• a UDI assigned to the device and its packaging, and the device and the manufacturer registered in EUDAMED (Art. 10(7)Regulation (EU) 2017/745, Medical Devices Regulation (consolidated text of 19 July 2026)Article 10, paragraph 7Click opens the article on EUR-Lex., Art. 27(3)Regulation (EU) 2017/745, Medical Devices Regulation (consolidated text of 19 July 2026)Article 27, paragraph 3Click opens the article on EUR-Lex., Art. 29(1)Regulation (EU) 2017/745, Medical Devices Regulation (consolidated text of 19 July 2026)Article 29, paragraph 1Click opens the article on EUR-Lex., Art. 31(1)Regulation (EU) 2017/745, Medical Devices Regulation (consolidated text of 19 July 2026)Article 31, paragraph 1Click opens the article on EUR-Lex.);
• a person responsible for regulatory compliance, with a relevant degree and a year’s experience, or four years’ experience in medical device regulation or quality management (Art. 15(1)Regulation (EU) 2017/745, Medical Devices Regulation (consolidated text of 19 July 2026)Article 15, paragraph 1Click opens the article on EUR-Lex.). A micro or small enterprise under Commission Recommendation 2003/361/EC may have that person permanently at its disposal instead of in its organisation (Art. 15(2)Regulation (EU) 2017/745, Medical Devices Regulation (consolidated text of 19 July 2026)Article 15, paragraph 2Click opens the article on EUR-Lex.);
• post-market surveillance, and incident reporting (Art. 10(10)Regulation (EU) 2017/745, Medical Devices Regulation (consolidated text of 19 July 2026)Article 10, paragraph 10Click opens the article on EUR-Lex., Art. 10(13)Regulation (EU) 2017/745, Medical Devices Regulation (consolidated text of 19 July 2026)Article 10, paragraph 13Click opens the article on EUR-Lex.);
• financial cover for liability for defective devices (Art. 10(16)Regulation (EU) 2017/745, Medical Devices Regulation (consolidated text of 19 July 2026)Article 10, paragraph 16Click opens the article on EUR-Lex.);
• the documents kept for at least 10 years after the last device is placed on the market, 15 for implantable devices (Art. 10(8)Regulation (EU) 2017/745, Medical Devices Regulation (consolidated text of 19 July 2026)Article 10, paragraph 8Click opens the article on EUR-Lex.).

The class decides who checks the manufacturer’s work (Art. 51(1)Regulation (EU) 2017/745, Medical Devices Regulation (consolidated text of 19 July 2026)Article 51, paragraph 1Click opens the article on EUR-Lex., Art. 52Regulation (EU) 2017/745, Medical Devices Regulation (consolidated text of 19 July 2026)Article 52Click opens the article on EUR-Lex.):

The CE marking goes on the device or its sterile packaging, and also on the instructions and on any sales packaging (Art. 20(3)Regulation (EU) 2017/745, Medical Devices Regulation (consolidated text of 19 July 2026)Article 20, paragraph 3Click opens the article on EUR-Lex.). Where a notified body was involved, its number follows the CE marking, and also appears in any promotional material that says the device meets the CE requirements (Art. 20(5)Regulation (EU) 2017/745, Medical Devices Regulation (consolidated text of 19 July 2026)Article 20, paragraph 5Click opens the article on EUR-Lex.). How CE marking works across all the laws that use it is in CE marking.

When the maker outside the EU needs an authorised representative

A manufacturer with no establishment in an EU country may place a device on the EU market only after designating a sole authorised representative (Art. 11(1)Regulation (EU) 2017/745, Medical Devices Regulation (consolidated text of 19 July 2026)Article 11, paragraph 1Click opens the article on EUR-Lex.). The mandate is valid only once the representative accepts it in writing, and it covers at least every device of the same generic device group (Art. 11(2)Regulation (EU) 2017/745, Medical Devices Regulation (consolidated text of 19 July 2026)Article 11, paragraph 2Click opens the article on EUR-Lex.). The representative keeps the technical documentation and declaration available for the authorities, carries out the registration duties, cooperates on corrective action and passes on complaints (Art. 11(3)Regulation (EU) 2017/745, Medical Devices Regulation (consolidated text of 19 July 2026)Article 11, paragraph 3Click opens the article on EUR-Lex.). It has its own person responsible for regulatory compliance at its disposal (Art. 15(6)Regulation (EU) 2017/745, Medical Devices Regulation (consolidated text of 19 July 2026)Article 15, paragraph 6Click opens the article on EUR-Lex.), and where the manufacturer has not met its obligations it is legally liable for defective devices together with the manufacturer (Art. 11(5)Regulation (EU) 2017/745, Medical Devices Regulation (consolidated text of 19 July 2026)Article 11, paragraph 5Click opens the article on EUR-Lex.).

This is not the GPSR responsible person. For a medical device, the MDR representative takes that place, and the GPSR role does not apply. The two roles are compared on EU authorised representative.

What an importer and a distributor must check

The Court of Justice spelled out the distributor’s check on 4 June 2026. You verify, from the information you have, that the CE marking and the declaration “clearly concern” a device under the MDR, and not, say, a CE marking as machinery. You do not have to check the device’s class. But if the information shows the manufacturer put the device in a class that needs a notified body, you check that the notified body’s four-digit number is there. A warning letter from a competitor can give you reason to believe a device does not conform; if you ask the manufacturer and it answers the claim is unfounded, you may rely on that answer unless it is manifestly unfounded (Case C-10/24, Dürr Dental, operative part).

If you believe a device does not conform, you do not sell it until it does, and you inform the manufacturer, its authorised representative and the importer. If it presents a serious risk or is falsified, you also inform the authority of the country where you are established (Art. 14(2)Regulation (EU) 2017/745, Medical Devices Regulation (consolidated text of 19 July 2026)Article 14, paragraph 2Click opens the article on EUR-Lex., Art. 13(2)Regulation (EU) 2017/745, Medical Devices Regulation (consolidated text of 19 July 2026)Article 13, paragraph 2Click opens the article on EUR-Lex.). An importer keeps a copy of the declaration and any certificate for the same period as the manufacturer (Art. 13(9)Regulation (EU) 2017/745, Medical Devices Regulation (consolidated text of 19 July 2026)Article 13, paragraph 9Click opens the article on EUR-Lex.). A distributor asked by an authority for the documents meets that duty when the manufacturer or the authorised representative supplies them (Art. 14(6)Regulation (EU) 2017/745, Medical Devices Regulation (consolidated text of 19 July 2026)Article 14, paragraph 6Click opens the article on EUR-Lex.).

Since 10 January 2025, a manufacturer that expects to interrupt or stop supplying a device, where that could seriously harm patients, tells the businesses it supplies directly, at least 6 months ahead save in exceptional circumstances. If you receive that notice, you pass it on without undue delay to the businesses, health institutions and professionals you supply (Art. 10a(1)Regulation (EU) 2017/745, Medical Devices Regulation (consolidated text of 19 July 2026)Article 10a, paragraph 1Click opens the article on EUR-Lex., Art. 10a(3)Regulation (EU) 2017/745, Medical Devices Regulation (consolidated text of 19 July 2026)Article 10a, paragraph 3Click opens the article on EUR-Lex.; Art. 3 of Regulation (EU) 2024/1860).

What applies now for UDI and EUDAMED

The EUDAMED dates hang on one notice. The obligations tied to a EUDAMED system apply “6 months from the date of publication of the notice” that the system works (Art. 123(3)(d)Regulation (EU) 2017/745, Medical Devices Regulation (consolidated text of 19 July 2026)Article 123, paragraph 3, point (d)Click opens the article on EUR-Lex.). The Commission published that notice for four systems, actor registration, UDI and devices, notified bodies and certificates, and market surveillance, in Commission Decision (EU) 2025/2371 on 27 November 2025 (Decision (EU) 2025/2371), and gives 28 May 2026 as the first day of mandatory use (European Commission). Devices already on the market that go on being placed on it after that date have to be registered “no later than 12 months from the date of publication” of the notice (Art. 123(3)(e)Regulation (EU) 2017/745, Medical Devices Regulation (consolidated text of 19 July 2026)Article 123, paragraph 3, point (e)Click opens the article on EUR-Lex.). The notice was published on 27 November 2025. Under the EU rules on time limits, the day of publication is not counted and a period in months ends on the same date in the last month, so the period ends on 27 November 2026 (Regulation (EEC, Euratom) No 1182/71, Art. 3(1) and 3(2)(c)). Register by 27 November 2026. The Commission’s own timeline shows 28 November 2026 (Commission timeline); the text of the Regulation supports the day before. The vigilance and clinical investigation systems are not yet declared functional.

Registration gives the manufacturer, the authorised representative and the importer a single registration number, the SRN (Art. 31(2)Regulation (EU) 2017/745, Medical Devices Regulation (consolidated text of 19 July 2026)Article 31, paragraph 2Click opens the article on EUR-Lex.). A change is entered within one week, and the data are confirmed one year after registration and every second year after that (Art. 31(4)Regulation (EU) 2017/745, Medical Devices Regulation (consolidated text of 19 July 2026)Article 31, paragraph 4Click opens the article on EUR-Lex., Art. 31(5)Regulation (EU) 2017/745, Medical Devices Regulation (consolidated text of 19 July 2026)Article 31, paragraph 5Click opens the article on EUR-Lex.). Within two weeks of placing a device on the market, an importer checks that the manufacturer or the authorised representative has registered, and adds its own details (Art. 30(3)Regulation (EU) 2017/745, Medical Devices Regulation (consolidated text of 19 July 2026)Article 30, paragraph 3Click opens the article on EUR-Lex.). The Commission confirms that distributors do not register in EUDAMED (EUDAMED Q&A, Q5). Who registers, how the SRN is issued and what the public site shows is on EUDAMED.

What the label and the instructions need, and in which language

The manufacturer supplies the label and instructions in the official language or languages set by the EU country where the device reaches the user or patient, and the label must be “indelible, easily legible and clearly comprehensible” (Art. 10(11)Regulation (EU) 2017/745, Medical Devices Regulation (consolidated text of 19 July 2026)Article 10, paragraph 11Click opens the article on EUR-Lex.). Each country sets its languages. The EU declaration of conformity is translated into the language or languages each country requires (Art. 19(1)Regulation (EU) 2017/745, Medical Devices Regulation (consolidated text of 19 July 2026)Article 19, paragraph 1Click opens the article on EUR-Lex.). A device sold into five countries may need five language versions of its label.

The label carries, among other things (Annex I, Section 23.2):

• the name or trade name of the device, and its intended purpose where that is not obvious;
• the manufacturer’s name or trade mark and registered address;
• the authorised representative’s name and address, if the manufacturer is outside the EU;
• the lot or serial number, and the UDI carrier;
• the use-by date where relevant, or the date of manufacture;
• storage conditions, warnings and precautions, and a single-use indication where it applies;
• an indication that the device is a medical device.

Instructions for use come with the device. A class I or IIa device that can be used safely without them may go without (Annex I, Section 23.1(d)). How these duties compare with the GPSR label is on GPSR labelling requirements.

What applies when you sell online

A device “offered by means of information society services”, as point (b) of Article 1(1) of Directive (EU) 2015/1535 defines them, to a person or business in the EU “shall comply with this Regulation” (Art. 6(1)Regulation (EU) 2017/745, Medical Devices Regulation (consolidated text of 19 July 2026)Article 6, paragraph 1Click opens the article on EUR-Lex.). A web shop outside the EU that ships to a buyer in the EU is covered, and so is a marketplace listing. Anyone offering a device that way gives an authority a copy of the EU declaration of conformity on request (Art. 6(3)Regulation (EU) 2017/745, Medical Devices Regulation (consolidated text of 19 July 2026)Article 6, paragraph 3Click opens the article on EUR-Lex.), and an EU country may, on public health grounds, require an online service to stop (Art. 6(4)Regulation (EU) 2017/745, Medical Devices Regulation (consolidated text of 19 July 2026)Article 6, paragraph 4Click opens the article on EUR-Lex.).

Your listing is advertising and making available. It may not claim functions the device does not have, create a false impression about treatment or diagnosis, leave out a likely risk, or suggest uses outside the intended purpose that was assessed (Art. 7Regulation (EU) 2017/745, Medical Devices Regulation (consolidated text of 19 July 2026)Article 7Click opens the article on EUR-Lex.). Changing the intended purpose of a device makes you its manufacturer (Art. 16(1)(b)Regulation (EU) 2017/745, Medical Devices Regulation (consolidated text of 19 July 2026)Article 16, paragraph 1, point (b)Click opens the article on EUR-Lex.).

What happens to devices certified under the old Directives

Until 26 May 2021 medical devices were placed on the market under Directive 93/42/EEC. Some of them, legacy devices, may still be placed on the market under the transition that Regulation (EU) 2023/607 extended:

Only where the manufacturer met the conditions: the device still complies with the Directive and has no significant change in design or purpose, it presents no unacceptable risk to the health or safety of patients, users or other persons, or to other aspects of public health, a quality management system was in place by 26 May 2024, an application to a notified body was lodged by 26 May 2024, and a written agreement with it was signed by 26 September 2024 (Art. 120(3c)Regulation (EU) 2017/745, Medical Devices Regulation (consolidated text of 19 July 2026)Article 120, paragraph 3cClick opens the article on EUR-Lex.). A class I device that needs no notified body under either law has no transition: it has had to meet the Regulation since 26 May 2021 (Art. 123(2)Regulation (EU) 2017/745, Medical Devices Regulation (consolidated text of 19 July 2026)Article 123, paragraph 2Click opens the article on EUR-Lex.).

Stock is not stranded. A device lawfully placed on the market under the Directives before 26 May 2021, or under the transition after it, “may continue to be made available on the market or put into service” (Art. 120(4)Regulation (EU) 2017/745, Medical Devices Regulation (consolidated text of 19 July 2026)Article 120, paragraph 4Click opens the article on EUR-Lex.). Regulation (EU) 2023/607 removed the old sell-off date so that this is “unlimited in time” (Regulation (EU) 2023/607, recital 10). A distributor asked about an older device checks that it was placed on the market in time; a legacy device carries no UDI duty (EUDAMED Q&A, footnote 14).

Where GPSR stops

The General Product Safety Regulation steps back for a medical device. For a product under Union harmonisation legislation, GPSR Art. 2(1)(b)Regulation (EU) 2023/988, General Product Safety RegulationArticle 2, paragraph 1, point (b)Click opens the article on EUR-Lex. switches off Chapter IIa (the emergency procedures, since 29 May 2026), Chapter III Section 1 (Articles 9 to 18: the GPSR manufacturer, importer and distributor duties, the technical documentation and the responsible person), Chapter V, Chapter VII and Chapters IX to XI (as amended by Art. 5 of Regulation (EU) 2024/2748). The MDR counts as such legislation: it is point 65 of Annex I to Regulation (EU) 2019/1020Regulation (EU) 2019/1020, Market Surveillance RegulationThe whole regulationClick opens the law on the EU Publications Office. (GPSR Art. 3(27)Regulation (EU) 2023/988, General Product Safety RegulationArticle 3, point 27Click opens the article on EUR-Lex.; Art. 2(1)Regulation (EU) 2019/1020, Market Surveillance RegulationArticle 2, paragraph 1Click opens the article on EUR-Lex., Annex I). The general safety requirement of Chapter II does not apply to the risks the MDR covers (GPSR Art. 2(1)(a)Regulation (EU) 2023/988, General Product Safety RegulationArticle 2, paragraph 1, point (a)Click opens the article on EUR-Lex.).

What stays: the listing information of GPSR Art. 19Regulation (EU) 2023/988, General Product Safety RegulationArticle 19Click opens the article on EUR-Lex., the online marketplace duties of Art. 22Regulation (EU) 2023/988, General Product Safety RegulationArticle 22Click opens the article on EUR-Lex., the Safety Gate, and the recall rules of Chapter VIII; the marketplace duties, the accident notification and the recall rules only as far as the MDR has no rule with the same aim (GPSR Art. 2(1)Regulation (EU) 2023/988, General Product Safety RegulationArticle 2, paragraph 1Click opens the article on EUR-Lex., recital 8). The MDR has its own: the manufacturer reports serious incidents and field safety corrective actions, and tells users by a field safety notice (Art. 87(1)Regulation (EU) 2017/745, Medical Devices Regulation (consolidated text of 19 July 2026)Article 87, paragraph 1Click opens the article on EUR-Lex., Art. 89(8)Regulation (EU) 2017/745, Medical Devices Regulation (consolidated text of 19 July 2026)Article 89, paragraph 8Click opens the article on EUR-Lex.), so the GPSR accident notification (GPSR Art. 20Regulation (EU) 2023/988, General Product Safety RegulationArticle 20Click opens the article on EUR-Lex.) gives way to that extent. A marketplace keeps asking for the same listing data for a device as for any product. The EU-operator rule of the Market Surveillance Regulation does not reach medical devices (Art. 4(5)Regulation (EU) 2019/1020, Market Surveillance RegulationArticle 4, paragraph 5Click opens the article on EUR-Lex.); the MDR’s own authorised representative does that job. What GPSR requires of every other product is in the GPSR guide.

What applies to tests you sell: in vitro diagnostic devices

Pregnancy tests, ovulation tests, blood glucose tests and self-tests for infections are in vitro diagnostic devices under Regulation (EU) 2017/746Regulation (EU) 2017/746, In Vitro Diagnostic Medical Devices Regulation (consolidated text of 10 January 2025)The whole regulationClick opens the law on the EU Publications Office., the IVDR, not the MDR (IVDR Art. 2(2)Regulation (EU) 2017/746, In Vitro Diagnostic Medical Devices Regulation (consolidated text of 10 January 2025)Article 2, point 2Click opens the article on EUR-Lex.; Art. 1(6)(a)Regulation (EU) 2017/745, Medical Devices Regulation (consolidated text of 19 July 2026)Article 1, paragraph 6, point (a)Click opens the article on EUR-Lex.). A self-test is class B or C and goes through a notified body, and tests already sold under the old Directive have transition dates up to 31 December 2029, by class; the classes, the roles and the dates are on IVDR.

What happens if you do nothing

The Regulation sets no fine. Each EU country lays down penalties that are “effective, proportionate, and dissuasive” (Art. 113Regulation (EU) 2017/745, Medical Devices Regulation (consolidated text of 19 July 2026)Article 113Click opens the article on EUR-Lex.). An authority that finds a device presents an unacceptable risk to health or safety requires the manufacturer, its authorised representative and the other businesses concerned, without delay, to take corrective action, to restrict or condition its sale, or to withdraw or recall it within a set period; if they do not, the authority prohibits or restricts its sale, withdraws it or recalls it (Art. 95(1)Regulation (EU) 2017/745, Medical Devices Regulation (consolidated text of 19 July 2026)Article 95, paragraph 1Click opens the article on EUR-Lex., Art. 95(4)Regulation (EU) 2017/745, Medical Devices Regulation (consolidated text of 19 July 2026)Article 95, paragraph 4Click opens the article on EUR-Lex.). A device that does not comply but presents no such risk gets a set period to end the non-compliance; if it does not end, the authority restricts or prohibits its sale, or has it withdrawn or recalled (Art. 97(1)Regulation (EU) 2017/745, Medical Devices Regulation (consolidated text of 19 July 2026)Article 97, paragraph 1Click opens the article on EUR-Lex., Art. 97(2)Regulation (EU) 2017/745, Medical Devices Regulation (consolidated text of 19 July 2026)Article 97, paragraph 2Click opens the article on EUR-Lex.). Before any of that, a device without CE marking, declaration or proper label is one a distributor may not sell and an importer may not place on the market (Art. 13(2)Regulation (EU) 2017/745, Medical Devices Regulation (consolidated text of 19 July 2026)Article 13, paragraph 2Click opens the article on EUR-Lex., Art. 14(2)Regulation (EU) 2017/745, Medical Devices Regulation (consolidated text of 19 July 2026)Article 14, paragraph 2Click opens the article on EUR-Lex.).

What the law leaves open

• Medical claims on a product that is not a device. Art. 16(1)(b)Regulation (EU) 2017/745, Medical Devices Regulation (consolidated text of 19 July 2026)Article 16, paragraph 1, point (b)Click opens the article on EUR-Lex. makes a reseller the manufacturer when it “changes the intended purpose of a device already placed on the market”. It speaks of a device. Whether a seller who lists an ordinary massager or support with medical claims thereby makes it a device, with itself as manufacturer, the Regulation does not say. The Court’s 2 July 2026 ruling that a product must also objectively perform a medical function (Case C-427/24) narrows it. Meanwhile: sell a product without a CE marking under the MDR with no medical claims at all.
• Who the importer is when you ship from outside the EU straight to a buyer. The importer is a business “established within the Union” (Art. 2(33)Regulation (EU) 2017/745, Medical Devices Regulation (consolidated text of 19 July 2026)Article 2, point 33Click opens the article on EUR-Lex.). A seller outside the EU shipping parcels direct has no importer in the chain, so the importer’s name on the device and its checks have no one to fall on. The manufacturer’s authorised representative is still required (Art. 11(1)Regulation (EU) 2017/745, Medical Devices Regulation (consolidated text of 19 July 2026)Article 11, paragraph 1Click opens the article on EUR-Lex.), and the device offered online still has to comply (Art. 6(1)Regulation (EU) 2017/745, Medical Devices Regulation (consolidated text of 19 July 2026)Article 6, paragraph 1Click opens the article on EUR-Lex.). Meanwhile: sell only a device whose label names the manufacturer’s EU authorised representative, make the importer’s checks of Art. 13(2)Regulation (EU) 2017/745, Medical Devices Regulation (consolidated text of 19 July 2026)Article 13, paragraph 2Click opens the article on EUR-Lex. yourself before you list it (CE marking and declaration, label and instructions, UDI), and keep the declaration ready for an authority (Art. 6(3)Regulation (EU) 2017/745, Medical Devices Regulation (consolidated text of 19 July 2026)Article 6, paragraph 3Click opens the article on EUR-Lex.).
• Whether a first-aid kit is a procedure pack. A procedure pack is a combination of products packaged together for “a specific medical purpose” (Art. 2(10)Regulation (EU) 2017/745, Medical Devices Regulation (consolidated text of 19 July 2026)Article 2, point 10Click opens the article on EUR-Lex.), and products other than devices belong in it only where they are used within a medical procedure or their presence is otherwise justified (Art. 22(1)(c)Regulation (EU) 2017/745, Medical Devices Regulation (consolidated text of 19 July 2026)Article 22, paragraph 1, point (c)Click opens the article on EUR-Lex.). A general first-aid kit serves first aid in general and often holds scissors, gloves or a blanket. The Regulation does not say whether such a kit qualifies. Meanwhile: meet the procedure-pack duties anyway: the statement, your name and address, the Annex I Section 23 information, and the kit’s own Basic UDI-DI in the UDI database (Art. 22(5)Regulation (EU) 2017/745, Medical Devices Regulation (consolidated text of 19 July 2026)Article 22, paragraph 5Click opens the article on EUR-Lex., Art. 29(2)Regulation (EU) 2017/745, Medical Devices Regulation (consolidated text of 19 July 2026)Article 29, paragraph 2Click opens the article on EUR-Lex.).
• Whose name the listing shows for a maker outside the EU. GPSR Art. 19Regulation (EU) 2023/988, General Product Safety RegulationArticle 19Click opens the article on EUR-Lex. point (b) asks for the GPSR responsible person or the operator of Art. 4(1)Regulation (EU) 2019/1020, Market Surveillance RegulationArticle 4, paragraph 1Click opens the article on EUR-Lex.. For a medical device neither exists: GPSR Art. 2(1)(b)Regulation (EU) 2023/988, General Product Safety RegulationArticle 2, paragraph 1, point (b)Click opens the article on EUR-Lex. switches off the first, and Art. 4(5)Regulation (EU) 2019/1020, Market Surveillance RegulationArticle 4, paragraph 5Click opens the article on EUR-Lex. leaves medical devices out of the second. Meanwhile: show the MDR authorised representative, whose name and address are on the label anyway.
• The MDR is being rewritten. The Commission proposed a simplification of the MDR and the IVDR on 16 December 2025 (COM(2025) 1023). On 5 October 2026 it was still before the European Parliament and the Council. Until an amending act is adopted and published, the Regulation applies as it stands.