IVDR, Regulation (EU) 2017/746: classes, notified bodies and transition dates for diagnostic tests

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 In Vitro Diagnostic Medical Devices Regulation or IVDR, covers the tests that examine a sample taken from the human body: pregnancy and ovulation tests, COVID and other rapid tests, blood glucose meters and strips, drug tests sold for a medical purpose, and the reagents, analysers and specimen containers laboratories use. It has applied since 26 May 2022 (IVDR Art. 113(2)Regulation (EU) 2017/746, In Vitro Diagnostic Medical Devices Regulation (consolidated text of 10 January 2025)Article 113, paragraph 2Click opens the article on EUR-Lex.). It sorts each test into a class, and the class decides whether a notified body has to check it. The roles work as under the EU MDR: manufacturer, authorised representative, importer, distributor.

Whether your product is an in vitro diagnostic device under the IVDR

An in vitro diagnostic medical device is “any medical device which is a reagent, reagent product, calibrator, control material, kit, instrument, apparatus, piece of equipment, software or system” intended by its manufacturer to examine specimens derived from the human body, “solely or principally” to provide information on a physiological or pathological process or state, a congenital impairment, a predisposition to a disease, compatibility with a recipient, a treatment response, or therapeutic measures (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.). The purpose is the one the manufacturer states on the label, in the instructions and in its promotional or sales material (IVDR Art. 2(12)Regulation (EU) 2017/746, In Vitro Diagnostic Medical Devices Regulation (consolidated text of 10 January 2025)Article 2, point 12Click opens the article on EUR-Lex.). A device for self-testing is one its maker intends for lay people, including tests used in testing services offered online (IVDR Art. 2(5)Regulation (EU) 2017/746, In Vitro Diagnostic Medical Devices Regulation (consolidated text of 10 January 2025)Article 2, point 5Click opens the article on EUR-Lex.).

The IVDR does not cover products for general laboratory use or research-use-only products, unless their maker specifically intends them for in vitro diagnosis; nor invasive sampling products or products applied directly to the body to obtain a specimen (IVDR Art. 1(3)Regulation (EU) 2017/746, In Vitro Diagnostic Medical Devices Regulation (consolidated text of 10 January 2025)Article 1, paragraph 3Click opens the article on EUR-Lex.). A lancet or a needle that draws the blood is therefore not an IVD; it is a medical device under the EU MDR instead. A device that has a medical device built in as an integral part falls under the EU MDR, with the IVDR applying to its diagnostic part (IVDR Art. 1(4)Regulation (EU) 2017/746, In Vitro Diagnostic Medical Devices Regulation (consolidated text of 10 January 2025)Article 1, paragraph 4Click opens the article on EUR-Lex.).

For the products online businesses meet most, the class follows from Annex VIII and the classification guidance the EU countries endorsed, MDCG 2020-16 rev.5 of September 2026:

A test with several stated purposes takes the highest class among them, and where several rules apply, the higher class wins (Annex VIII, Sections 1.8 and 1.9).

Which class your test is in: the seven IVDR rules

The rules are in Annex VIII, Section 2. The manufacturer applies them; a dispute between it and its notified body goes to the authority of the country where the manufacturer, or for a maker outside the EU its authorised representative, has its registered place of business (IVDR Art. 47(2)Regulation (EU) 2017/746, In Vitro Diagnostic Medical Devices Regulation (consolidated text of 10 January 2025)Article 47, paragraph 2Click opens the article on EUR-Lex.).

When a notified body is needed under the IVDR

A self-test or near-patient test of class B, C or D gets one more step: the notified body assesses its technical documentation under Section 5.1 of Annex IX, including the studies with intended users that show a lay person can use it (IVDR Art. 48(3)Regulation (EU) 2017/746, In Vitro Diagnostic Medical Devices Regulation (consolidated text of 10 January 2025)Article 48, paragraph 3Click opens the article on EUR-Lex., Art. 48(7)Regulation (EU) 2017/746, In Vitro Diagnostic Medical Devices Regulation (consolidated text of 10 January 2025)Article 48, paragraph 7Click opens the article on EUR-Lex., Art. 48(9)Regulation (EU) 2017/746, In Vitro Diagnostic Medical Devices Regulation (consolidated text of 10 January 2025)Article 48, paragraph 9Click opens the article on EUR-Lex.). Every pregnancy, COVID or glucose self-test therefore carries a notified body’s number after its CE marking.

The CE marking goes on the device or its sterile packaging, and also on the instructions and any sales packaging. The notified body’s number also appears in any promotional material that says the device meets the CE requirements (IVDR Art. 18(3)Regulation (EU) 2017/746, In Vitro Diagnostic Medical Devices Regulation (consolidated text of 10 January 2025)Article 18, paragraph 3Click opens the article on EUR-Lex., Art. 18(5)Regulation (EU) 2017/746, In Vitro Diagnostic Medical Devices Regulation (consolidated text of 10 January 2025)Article 18, paragraph 5Click opens the article on EUR-Lex.). A class B self-test listed with “CE” and no four-digit number is missing something. How CE marking works across all the laws that use it is in CE marking.

Which role you hold under the IVDR

The own-brand rule catches anyone who buys tests from a factory and sells them under their own label: that makes you the manufacturer, with the class, the notified body, the technical documentation and every other duty below. The one way out is an agreement under which the real manufacturer is named as manufacturer on the label and carries the manufacturer’s duties (IVDR Art. 16(1)(a)Regulation (EU) 2017/746, In Vitro Diagnostic Medical Devices Regulation (consolidated text of 10 January 2025)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 business, carries these duties 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.:

• a risk management system and a performance evaluation, with post-market performance follow-up (Art. 10(2)Regulation (EU) 2017/746, In Vitro Diagnostic Medical Devices Regulation (consolidated text of 10 January 2025)Article 10, paragraph 2Click opens the article on EUR-Lex., Art. 10(3)Regulation (EU) 2017/746, In Vitro Diagnostic Medical Devices Regulation (consolidated text of 10 January 2025)Article 10, paragraph 3Click opens the article on EUR-Lex.);
• technical documentation to Annexes II and III (Art. 10(4)Regulation (EU) 2017/746, In Vitro Diagnostic Medical Devices Regulation (consolidated text of 10 January 2025)Article 10, paragraph 4Click opens the article on EUR-Lex.);
• the conformity assessment for the class, then the EU declaration of conformity and the CE marking (Art. 10(5)Regulation (EU) 2017/746, In Vitro Diagnostic Medical Devices Regulation (consolidated text of 10 January 2025)Article 10, paragraph 5Click opens the article on EUR-Lex., Art. 48Regulation (EU) 2017/746, In Vitro Diagnostic Medical Devices Regulation (consolidated text of 10 January 2025)Article 48Click opens the article on EUR-Lex.);
• a UDI assigned to the device, and the registration duties in EUDAMED (Art. 10(6)Regulation (EU) 2017/746, In Vitro Diagnostic Medical Devices Regulation (consolidated text of 10 January 2025)Article 10, paragraph 6Click opens the article on EUR-Lex., Art. 24(3)Regulation (EU) 2017/746, In Vitro Diagnostic Medical Devices Regulation (consolidated text of 10 January 2025)Article 24, paragraph 3Click opens the article on EUR-Lex., Art. 26(1)Regulation (EU) 2017/746, In Vitro Diagnostic Medical Devices Regulation (consolidated text of 10 January 2025)Article 26, paragraph 1Click opens the article on EUR-Lex.);
• a quality management system proportionate to the risk class and type of device (Art. 10(8)Regulation (EU) 2017/746, In Vitro Diagnostic Medical Devices Regulation (consolidated text of 10 January 2025)Article 10, paragraph 8Click opens the article on EUR-Lex.);
• the documents kept for at least 10 years after the last device is placed on the market (Art. 10(7)Regulation (EU) 2017/746, In Vitro Diagnostic Medical Devices Regulation (consolidated text of 10 January 2025)Article 10, paragraph 7Click opens the article on EUR-Lex.);
• post-market surveillance, and the label and instructions in the right languages (Art. 10(9)Regulation (EU) 2017/746, In Vitro Diagnostic Medical Devices Regulation (consolidated text of 10 January 2025)Article 10, paragraph 9Click opens the article on EUR-Lex., Art. 10(10)Regulation (EU) 2017/746, In Vitro Diagnostic Medical Devices Regulation (consolidated text of 10 January 2025)Article 10, paragraph 10Click opens the article on EUR-Lex.);
• a person responsible for regulatory compliance, with a relevant degree and a year’s experience in IVD regulatory affairs or quality management, or four years’ experience. A micro or small enterprise may have that person permanently and continuously at its disposal instead of in its organisation (Art. 15(1)Regulation (EU) 2017/746, In Vitro Diagnostic Medical Devices Regulation (consolidated text of 10 January 2025)Article 15, paragraph 1Click opens the article on EUR-Lex., Art. 15(2)Regulation (EU) 2017/746, In Vitro Diagnostic Medical Devices Regulation (consolidated text of 10 January 2025)Article 15, paragraph 2Click opens the article on EUR-Lex.);
• financial cover for its liability for defective devices (Art. 10(15)Regulation (EU) 2017/746, In Vitro Diagnostic Medical Devices Regulation (consolidated text of 10 January 2025)Article 10, paragraph 15Click opens the article on EUR-Lex.).

Since 10 January 2025, a manufacturer that expects to interrupt or stop supplying a test, where that could seriously harm patients or public health, tells its competent authority and the businesses, health institutions and healthcare professionals 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) 2017/746, In Vitro Diagnostic Medical Devices Regulation (consolidated text of 10 January 2025)Article 10a, paragraph 1Click opens the article on EUR-Lex., Art. 10a(3)Regulation (EU) 2017/746, In Vitro Diagnostic Medical Devices Regulation (consolidated text of 10 January 2025)Article 10a, paragraph 3Click opens the article on EUR-Lex.). That article was inserted by Regulation (EU) 2024/1860, whose third article sets that date.

When the maker outside the EU needs an authorised representative

A manufacturer not established in an EU country may place a device on the EU market only after designating a sole authorised representative (IVDR Art. 11(1)Regulation (EU) 2017/746, In Vitro Diagnostic Medical Devices Regulation (consolidated text of 10 January 2025)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 (IVDR Art. 11(2)Regulation (EU) 2017/746, In Vitro Diagnostic Medical Devices Regulation (consolidated text of 10 January 2025)Article 11, paragraph 2Click opens the article on EUR-Lex.). The representative checks that the declaration and technical documentation exist, keeps them available for the authorities, registers in EUDAMED and checks the manufacturer’s registrations, cooperates on corrective action and passes on complaints (IVDR Art. 11(3)Regulation (EU) 2017/746, In Vitro Diagnostic Medical Devices Regulation (consolidated text of 10 January 2025)Article 11, paragraph 3Click opens the article on EUR-Lex.). It has its own person responsible for regulatory compliance at its disposal (IVDR Art. 15(6)Regulation (EU) 2017/746, In Vitro Diagnostic Medical Devices Regulation (consolidated text of 10 January 2025)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 (IVDR Art. 11(5)Regulation (EU) 2017/746, In Vitro Diagnostic Medical Devices Regulation (consolidated text of 10 January 2025)Article 11, paragraph 5Click opens the article on EUR-Lex.).

This is not the GPSR responsible person. For an IVD, the IVDR representative takes that place. The two roles are compared on EU authorised representative.

What an importer and a distributor must check

If you believe a test 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 (IVDR Art. 13(2)Regulation (EU) 2017/746, In Vitro Diagnostic Medical Devices Regulation (consolidated text of 10 January 2025)Article 13, paragraph 2Click opens the article on EUR-Lex., Art. 14(2)Regulation (EU) 2017/746, In Vitro Diagnostic Medical Devices Regulation (consolidated text of 10 January 2025)Article 14, paragraph 2Click opens the article on EUR-Lex.). Where the label sets storage or handling conditions, such as a temperature range for strips or reagents, you keep to them while the stock is yours (IVDR Art. 13(5)Regulation (EU) 2017/746, In Vitro Diagnostic Medical Devices Regulation (consolidated text of 10 January 2025)Article 13, paragraph 5Click opens the article on EUR-Lex., Art. 14(3)Regulation (EU) 2017/746, In Vitro Diagnostic Medical Devices Regulation (consolidated text of 10 January 2025)Article 14, paragraph 3Click opens the article on EUR-Lex.; Annex I, Section 20.2(k)). Every business in the chain can name, for 10 years, the businesses it bought from and sold to, and the health institutions and professionals it supplied directly (IVDR Art. 22(2)Regulation (EU) 2017/746, In Vitro Diagnostic Medical Devices Regulation (consolidated text of 10 January 2025)Article 22, paragraph 2Click 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 (IVDR Art. 14(6)Regulation (EU) 2017/746, In Vitro Diagnostic Medical Devices Regulation (consolidated text of 10 January 2025)Article 14, paragraph 6Click opens the article on EUR-Lex.).

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 test reaches the user or patient. For a self-test or near-patient test the information must also be “easily understandable” (IVDR Art. 10(10)Regulation (EU) 2017/746, In Vitro Diagnostic Medical Devices Regulation (consolidated text of 10 January 2025)Article 10, paragraph 10Click 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 (IVDR Art. 17(1)Regulation (EU) 2017/746, In Vitro Diagnostic Medical Devices Regulation (consolidated text of 10 January 2025)Article 17, paragraph 1Click opens the article on EUR-Lex.). A test sold into five countries may need five language versions of its label and leaflet.

The label carries, among other things (Annex I, Section 20.2):

• 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;
• an indication that it is an in vitro diagnostic medical device;
• the lot or serial number, and the UDI carrier;
• the use-by date, at least as year and month, or the date of manufacture;
• storage and handling conditions, and warnings;
• for a self-test or near-patient test, an indication of that fact; for a rapid test not meant for either, an explicit statement that it is not;
• for a self-test, the type of specimen, such as blood, urine or saliva, any additional materials needed, and contact details for advice.

The name of a self-test may not suggest a purpose other than the one its maker states (Annex I, Section 20.2(u)). The instructions of a self-test explain how to take the specimen, run the test and read the result; what to do on a positive, negative or unclear result; the chance of a false result; and they tell the user not to take any decision of medical relevance without first consulting a healthcare professional (Annex I, Section 20.4.2). Each self-test comes with its own instructions: the option of one copy for several devices delivered to one place does not cover self-tests (Annex I, Section 20.1(e)). A reagent containing a hazardous mixture also carries the CLP hazard pictograms (Annex I, Section 20.1(i)).

What applies to self-tests sold online

A device “offered by means of information society services” to a person or business in the EU “shall comply with this Regulation” (IVDR Art. 6(1)Regulation (EU) 2017/746, In Vitro Diagnostic Medical Devices Regulation (consolidated text of 10 January 2025)Article 6, paragraph 1Click opens the article on EUR-Lex.). A web shop outside the EU that ships a pregnancy or COVID test 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 (IVDR Art. 6(3)Regulation (EU) 2017/746, In Vitro Diagnostic Medical Devices Regulation (consolidated text of 10 January 2025)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 (IVDR Art. 6(4)Regulation (EU) 2017/746, In Vitro Diagnostic Medical Devices Regulation (consolidated text of 10 January 2025)Article 6, paragraph 4Click opens the article on EUR-Lex.). A device used for a testing service offered online to lay people is a device for self-testing (IVDR Art. 2(5)Regulation (EU) 2017/746, In Vitro Diagnostic Medical Devices Regulation (consolidated text of 10 January 2025)Article 2, point 5Click opens the article on EUR-Lex.), and a device used to provide a diagnostic service online to people in the EU must comply even if it is never placed on the market (IVDR Art. 6(2)Regulation (EU) 2017/746, In Vitro Diagnostic Medical Devices Regulation (consolidated text of 10 January 2025)Article 6, paragraph 2Click opens the article on EUR-Lex.).

Your listing is advertising. It may not claim functions or accuracy the test does not have, create a false impression about diagnosis, leave out a likely risk, or suggest uses outside the purpose that was assessed (IVDR Art. 7Regulation (EU) 2017/746, In Vitro Diagnostic Medical Devices Regulation (consolidated text of 10 January 2025)Article 7Click opens the article on EUR-Lex.). Selling a professional test as a home test changes its intended purpose and makes you its manufacturer (IVDR Art. 16(1)(b)Regulation (EU) 2017/746, In Vitro Diagnostic Medical Devices Regulation (consolidated text of 10 January 2025)Article 16, paragraph 1, point (b)Click opens the article on EUR-Lex.): a professional test carries no self-testing assessment, and a professional rapid test’s label says it is not for self-testing (Annex I, Section 20.2(r)).

A CE-marked self-test is not free to be sold everywhere. The IVDR leaves EU countries free to restrict the use of a specific type of device on grounds it does not cover, and to keep national rules that a device may only be supplied on prescription or by certain professionals or institutions (IVDR Art. 1(8)Regulation (EU) 2017/746, In Vitro Diagnostic Medical Devices Regulation (consolidated text of 10 January 2025)Article 1, paragraph 8Click opens the article on EUR-Lex., Art. 1(9)Regulation (EU) 2017/746, In Vitro Diagnostic Medical Devices Regulation (consolidated text of 10 January 2025)Article 1, paragraph 9Click opens the article on EUR-Lex.). For each country you ship to, its national rule on who may supply the test applies on top of the IVDR.

The listing also shows the manufacturer’s name and address, the product identification and picture, and its warnings in the buyer’s language (GPSR Art. 19Regulation (EU) 2023/988, General Product Safety RegulationArticle 19Click opens the article on EUR-Lex.).

What applies now for UDI and EUDAMED

The EUDAMED duties apply 6 months after the Commission publishes a notice that the system works, and the deadline for devices already on the market is 6 months after that (IVDR Art. 113(3)(f)Regulation (EU) 2017/746, In Vitro Diagnostic Medical Devices Regulation (consolidated text of 10 January 2025)Article 113, paragraph 3, point (f)Click opens the article on EUR-Lex., Art. 113(3)(fa)Regulation (EU) 2017/746, In Vitro Diagnostic Medical Devices Regulation (consolidated text of 10 January 2025)Article 113, paragraph 3, point (fa)Click opens the article on EUR-Lex.). The notice for four systems covers both the MDR and the IVDR. It was published on 27 November 2025 (Decision (EU) 2025/2371). The Commission gives 28 May 2026 as the first day of mandatory use (European Commission). Six months from that date, 28 November 2026, is the registration deadline for IVDs already on the market (Commission timeline). The vigilance and performance study systems are not yet declared functional.

Registration gives the manufacturer, the authorised representative and the importer a single registration number, the SRN (IVDR Art. 28(2)Regulation (EU) 2017/746, In Vitro Diagnostic Medical Devices Regulation (consolidated text of 10 January 2025)Article 28, 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 (IVDR Art. 28(4)Regulation (EU) 2017/746, In Vitro Diagnostic Medical Devices Regulation (consolidated text of 10 January 2025)Article 28, paragraph 4Click opens the article on EUR-Lex., Art. 28(5)Regulation (EU) 2017/746, In Vitro Diagnostic Medical Devices Regulation (consolidated text of 10 January 2025)Article 28, paragraph 5Click opens the article on EUR-Lex.). How the database works, step by step, is on EUDAMED.

What happens to tests placed on the market under the old Directive

Until 26 May 2022, IVDs were placed on the market under Directive 98/79/EC. Tests that were self-declared under the Directive and now need a notified body, and tests with a Directive certificate, are legacy tests. Two amending acts gave them more time: Regulation (EU) 2022/112 set dates by class, and Regulation (EU) 2024/1860 moved them to the dates now in force:

Only where the manufacturer meets every condition: the test still complies with the Directive, has no significant change in design or purpose, and presents no unacceptable risk; a quality management system under the IVDR was in place by 26 May 2025; and the application and the written agreement were made by the dates in the table (IVDR Art. 110(3c)Regulation (EU) 2017/746, In Vitro Diagnostic Medical Devices Regulation (consolidated text of 10 January 2025)Article 110, paragraph 3cClick opens the article on EUR-Lex.). A Directive certificate issued from 25 May 2017, still valid on 26 May 2022 and not withdrawn since, stays valid until 31 December 2027, even past the expiry date printed on it. One that expired before 9 July 2024 counts only if, before it expired, the maker signed a written agreement with a notified body for the test or its replacement, or an authority granted a derogation or required the maker to carry out the conformity assessment (IVDR Art. 110(2)Regulation (EU) 2017/746, In Vitro Diagnostic Medical Devices Regulation (consolidated text of 10 January 2025)Article 110, paragraph 2Click opens the article on EUR-Lex.). On 6 October 2026 both deadlines have passed for tests with a Directive certificate and for self-declared legacy tests now in class C or D. A self-declared legacy class C test whose maker signed no agreement with a notified body by 26 September 2026 may no longer be placed on the market under the transition. For a self-declared legacy class B test, the application is due by 26 May 2027.

The post-market surveillance, vigilance, market surveillance and registration rules of the IVDR already apply to legacy tests (IVDR Art. 110(3d)Regulation (EU) 2017/746, In Vitro Diagnostic Medical Devices Regulation (consolidated text of 10 January 2025)Article 110, paragraph 3dClick opens the article on EUR-Lex.). A class A test not sold sterile has no transition: it needs no notified body under either law, so it has had to meet the IVDR since 26 May 2022 (IVDR Art. 113(2)Regulation (EU) 2017/746, In Vitro Diagnostic Medical Devices Regulation (consolidated text of 10 January 2025)Article 113, paragraph 2Click opens the article on EUR-Lex.).

Stock is not stranded. A test lawfully placed on the market under the Directive before 26 May 2022, or under the transition after it, “may continue to be made available on the market or put into service” (IVDR Art. 110(4)Regulation (EU) 2017/746, In Vitro Diagnostic Medical Devices Regulation (consolidated text of 10 January 2025)Article 110, paragraph 4Click opens the article on EUR-Lex.), with no end date. As a distributor, check that an older test was placed on the market in time, not that it meets the IVDR.

Where GPSR stops for an IVD

The General Product Safety Regulation steps back for an in vitro diagnostic device. The IVDR is Union harmonisation legislation, point 66 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.), so 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 its own manufacturer, importer and distributor duties, its technical documentation and its responsible person, and the general safety requirement does not apply to the risks the IVDR 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.). The EU-operator rule of the Market Surveillance Regulation does not reach IVDs (Art. 4(5)Regulation (EU) 2019/1020, Market Surveillance RegulationArticle 4, paragraph 5Click opens the article on EUR-Lex.); the IVDR’s own authorised representative does that job.

What stays is the listing information of GPSR Art. 19Regulation (EU) 2023/988, General Product Safety RegulationArticle 19Click opens the article on EUR-Lex.: a marketplace asks for the same data for a test as for any product. For the name it asks for under a maker outside the EU, show the IVDR authorised representative, whose name and address are on the label anyway. What GPSR requires of every other product is in the GPSR guide.

IVDs in Great Britain and Northern Ireland

Northern Ireland follows the EU IVDR, which has applied there since 26 May 2022. Great Britain (England, Wales and Scotland) has its own law, the UK Medical Devices Regulations 2002, with the UKCA marking. Its regulator, the MHRA, states (MHRA guidance, updated 20 February 2026):

• IVDs that comply with the EU IVDR and carry the CE marking can be placed on the Great Britain market until 30 June 2030; IVDs under the old Directive until the earlier of their certificate’s expiry or 30 June 2030;
• an IVD self-declared under the old Directive qualifies only if its declaration was made before 26 May 2022 and still lets it be placed on the EU market under the IVDR transition; the dates do not apply to general IVDs that need no notified body under either the Directive or the IVDR;
• every IVD is registered with the MHRA before it is placed on the Great Britain market;
• a manufacturer outside the UK appoints a single UK responsible person, who registers its devices; on a CE-marked device the UK responsible person’s details need not be on the label, unless the device carries both CE and UKCA markings;
• the UKCA marking is not recognised in the EU or in Northern Ireland.

What happens if you do nothing

The IVDR sets no fine. Each EU country lays down penalties that are “effective, proportionate, and dissuasive” (IVDR Art. 106Regulation (EU) 2017/746, In Vitro Diagnostic Medical Devices Regulation (consolidated text of 10 January 2025)Article 106Click opens the article on EUR-Lex.). An authority that has reason to believe a test presents an unacceptable risk or otherwise does not comply evaluates it, and the businesses concerned cooperate (IVDR Art. 89Regulation (EU) 2017/746, In Vitro Diagnostic Medical Devices Regulation (consolidated text of 10 January 2025)Article 89Click opens the article on EUR-Lex.). Where the risk is unacceptable, it requires the manufacturer, its authorised representative and the other businesses concerned, without delay, to take corrective action, to restrict the test’s sale, or to withdraw or recall it; if they do not, the authority prohibits or restricts its sale, withdraws it or recalls it (IVDR Art. 90(1)Regulation (EU) 2017/746, In Vitro Diagnostic Medical Devices Regulation (consolidated text of 10 January 2025)Article 90, paragraph 1Click opens the article on EUR-Lex., Art. 90(4)Regulation (EU) 2017/746, In Vitro Diagnostic Medical Devices Regulation (consolidated text of 10 January 2025)Article 90, paragraph 4Click opens the article on EUR-Lex.). A test 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 (IVDR Art. 92(1)Regulation (EU) 2017/746, In Vitro Diagnostic Medical Devices Regulation (consolidated text of 10 January 2025)Article 92, paragraph 1Click opens the article on EUR-Lex., Art. 92(2)Regulation (EU) 2017/746, In Vitro Diagnostic Medical Devices Regulation (consolidated text of 10 January 2025)Article 92, paragraph 2Click opens the article on EUR-Lex.). Before any of that, a test without CE marking, declaration or proper label is one a distributor may not sell and an importer may not place on the market (IVDR Art. 13(2)Regulation (EU) 2017/746, In Vitro Diagnostic Medical Devices Regulation (consolidated text of 10 January 2025)Article 13, paragraph 2Click opens the article on EUR-Lex., Art. 14(2)Regulation (EU) 2017/746, In Vitro Diagnostic Medical Devices Regulation (consolidated text of 10 January 2025)Article 14, paragraph 2Click opens the article on EUR-Lex.).

What the law leaves open

• Drug and alcohol tests with no medical purpose. An IVD is first a medical device, and its information has to concern a physiological or pathological state, a predisposition, or a treatment (IVDR Art. 2(1)Regulation (EU) 2017/746, In Vitro Diagnostic Medical Devices Regulation (consolidated text of 10 January 2025)Article 2, point 1Click opens the article on EUR-Lex., 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.). A drug test sold for workplace, roadside or forensic screening states no such purpose. The IVDR does not name these tests, and the EU classification guidance, MDCG 2020-16 rev.5, gives no example of them. Meanwhile: the intended purpose on the label, the leaflet and your listing decides. A test its maker intends for lay people, to check health or treatment, is a class C self-test; do not add medical claims to a test placed on the market without a CE marking.
• Who the importer is when you ship from outside the EU straight to a buyer. The importer is a business “established within the Union” (IVDR Art. 2(26)Regulation (EU) 2017/746, In Vitro Diagnostic Medical Devices Regulation (consolidated text of 10 January 2025)Article 2, point 26Click opens the article on EUR-Lex.). A business outside the EU shipping parcels direct to consumers has no importer in the chain, so the importer’s name on the test and its checks fall on no one. Where the buyer is a business in the EU that brings the test in from outside the EU, that buyer places it on the EU market and is the importer (IVDR Art. 2(26)Regulation (EU) 2017/746, In Vitro Diagnostic Medical Devices Regulation (consolidated text of 10 January 2025)Article 2, point 26Click opens the article on EUR-Lex.). The manufacturer’s authorised representative is still required (IVDR Art. 11(1)Regulation (EU) 2017/746, In Vitro Diagnostic Medical Devices Regulation (consolidated text of 10 January 2025)Article 11, paragraph 1Click opens the article on EUR-Lex.), and the test offered online still has to comply (IVDR Art. 6(1)Regulation (EU) 2017/746, In Vitro Diagnostic Medical Devices Regulation (consolidated text of 10 January 2025)Article 6, paragraph 1Click opens the article on EUR-Lex.). Meanwhile: sell only a test whose label names the manufacturer’s EU authorised representative, make the importer’s checks of IVDR Art. 13(2)Regulation (EU) 2017/746, In Vitro Diagnostic Medical Devices Regulation (consolidated text of 10 January 2025)Article 13, paragraph 2Click opens the article on EUR-Lex. yourself before you list it, and keep the declaration ready for an authority (IVDR Art. 6(3)Regulation (EU) 2017/746, In Vitro Diagnostic Medical Devices Regulation (consolidated text of 10 January 2025)Article 6, paragraph 3Click opens the article on EUR-Lex.).
• The IVDR is being rewritten. The Commission proposed a simplification of the MDR and the IVDR on 16 December 2025 (COM(2025) 1023). On 6 October 2026 no amending act had been published in the Official Journal. Until one is, the Regulation applies as it stands.