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MDR and IVDR Compliance: The Programme Step by Step, from Gap Analysis to Certificate

MDR and IVDR compliance step by step: qualify, classify, pick the route, run the QMS, build evidence, register, pass the notified body, CE mark, monitor.

Last updated 12 November 2026 · By the IVDR Guide Editorial Team · How we fact-check · Print this page

Summary

MDR and IVDR compliance is the programme a manufacturer runs to place devices on the EU market or put them into service under Regulation (EU) 2017/745 (the MDR, applicable since 26 May 2021) and Regulation (EU) 2017/746 (the IVDR, applicable since 26 May 2022): qualify the product, classify it, choose the conformity assessment route, run the quality management system of MDR Article 10(9) or IVDR Article 10(8), build the technical documentation and the clinical or performance evidence, register in EUDAMED, involve a notified body where the class requires one, sign the EU declaration of conformity, affix the CE marking, run post-market surveillance and vigilance, and have a person responsible for regulatory compliance (PRRC) under MDR and IVDR Article 15.

Authorised representatives, importers and distributors run their own part of the programme under MDR and IVDR Articles 11, 13 and 14.

Below follow the 11 steps, the open IVDR conditions, certification times, quote factors and four detailed pages.

What Compliance Means in Practice

Compliance with the MDR and the IVDR means that every device a manufacturer places on the EU market or puts into service meets the general safety and performance requirements and has passed the conformity assessment for its class, and that the manufacturer keeps the system, documents and surveillance that the two regulations require for as long as the device is on the market. Both acts have been in force since 25 May 2017 (MDR Article 123(1), IVDR Article 113(1)); as regulations, they are directly applicable without transposition, and national laws implement only what the two regulations leave to member states.

MDR compliance and IVDR compliance follow the same 11 steps, with classes A to D for IVDs instead of classes I to III. How the EU MDR and IVDR fit together as two parallel regulations is explained in the overview of the EU MDR and IVDR.

MDR Article 10(9) requires every manufacturer to have a quality management system proportionate to the risk class and the type of device, and IVDR Article 10(8) sets the same duty for IVDs. The system covers at least 13 aspects, points (a) to (m). Point (a) is "a strategy for regulatory compliance, including compliance with conformity assessment procedures and procedures for management of modifications".

A compliance programme is therefore a legal duty under both regulations, not a project choice. MDR implementation and IVDR implementation are the work of building that strategy and running it for every device the system covers. In point (f), the IVDR list addresses performance evaluation under IVDR Annex XIII, including post-market performance follow-up (PMPF), where the MDR list addresses clinical evaluation.

The Commission's 12-Step Implementation Model

The Commission's Implementation Model for the medical devices Regulation is a 12-step guide dated 1 August 2020 and still linked on the Commission's "Getting ready for the new regulations" page as of 6 November 2026. Its 12 steps are listed below.

  1. Pre-assessment
  2. Gap analysis and actions resulting from this
  3. Quality Management System (QMS)
  4. Legal entities
  5. Portfolio
  6. Master implementation plan
  7. Notified Bodies
  8. Regulatory training
  9. Execute master implementation plan
  10. Review efficiency and effectiveness
  11. Notified Body submission
  12. Ongoing monitoring

The model is a Commission planning aid, not law. Step 3 asks manufacturers to identify or hire the PRRC (Article 15) and make sure the person is adequately qualified and trained. Step 4 asks them to "ensure product liability insurance is adequate", which matches the liability cover duty of MDR Article 10(16) and IVDR Article 10(15). Step 12 asks for monitoring of the developing guidance and a procedure for unannounced notified-body inspections.

The Commission's IVDR version of the model works with classes A to D, IVDR Article 56 and a PMPF plan under IVDR Annex XIII Part B. The MDR version of the model serves the EU MDR, covered in full under EU MDR (Regulation (EU) 2017/745).

The Programme in Eleven Steps, Each with Its Owner Page

A compliance programme under either regulation runs through 11 steps, from deciding whether the product is a device at all to the post-market duties that last as long as the device is sold, and each step has one page on this site that covers it in full. The order follows how the steps depend on each other, as the diagram below the table shows. The table gives each step with its MDR and IVDR basis.

Step What is decided or produced MDR basis IVDR basis Owner page
1. Qualification Device, IVD or Annex XVI product MDR Articles 1, 2(1) IVDR Article 2(2) MDR and IVDR definitions
2. Classification Class I, IIa, IIb, III (Is, Im, Ir) or class A to D MDR Article 51, Annex VIII (22 rules) IVDR Article 47, Annex VIII (7 rules) MDR classification; IVDR classification
3. Conformity route Annex route and notified-body involvement MDR Article 52, Annexes IX to XI IVDR Article 48, Annexes IX to XI MDR conformity assessment; IVDR conformity assessment
4. Quality management system QMS with points (a) to (m) MDR Article 10(9) IVDR Article 10(8) manufacturer obligations
5. Technical documentation Annex II and Annex III files MDR Article 10(4), Annexes II, III IVDR Article 10(4), Annexes II, III MDR and IVDR technical documentation
6. Clinical or performance evidence Clinical evaluation or performance evaluation MDR Article 61, Annex XIV IVDR Article 56, Annex XIII clinical evaluation under the MDR; IVDR performance evaluation
7. UDI and EUDAMED registration UDI assignment, actor and device data MDR Articles 27 to 29, 31 IVDR Articles 24 to 26, 28 UDI under the MDR and IVDR; EUDAMED
8. Notified body Assessment and certificate MDR Articles 52, 56 IVDR Articles 48, 51 notified bodies for the MDR and IVDR
9. Declaration and CE marking EU declaration of conformity, CE marking MDR Articles 10(6), 19, 20; Annexes IV, V IVDR Articles 10(5), 17, 18; Annexes IV, V EU declaration of conformity; CE marking for medical devices and IVDs
10. PMS and vigilance PMS system, plan and reports; incident reporting MDR Articles 83 to 87 IVDR Articles 78 to 82 post-market surveillance under the MDR and IVDR; vigilance under the MDR and IVDR
11. PRRC Person in the organisation; for micro and small enterprises, permanently and continuously at their disposal MDR Article 15 IVDR Article 15 person responsible for regulatory compliance

Steps 1 to 3: Scope, Risk Category and Route

Step 1 decides whether the product is a medical device under MDR Article 2(1), an in vitro diagnostic medical device under IVDR Article 2(2) or an Annex XVI product under MDR Article 1. Step 2 applies the 22 rules of MDR Annex VIII (classes I, IIa, IIb and III; MDR Article 51) or the 7 rules of IVDR Annex VIII (classes A to D; IVDR Article 47). Step 3 picks the route from Annexes IX to XI (MDR Article 52, IVDR Article 48).

Notified-body involvement follows from the route. MDR class I devices outside the class I sub-types Is, Im and Ir and non-sterile IVDR class A devices are self-certified, and their CE marking carries no notified-body number (MDR Article 20(5), IVDR Article 18(5)). An indicative device class, with the Annex VIII rule behind each answer, comes from the device class finder.

Steps 4 to 7: Quality System, Documentation, Evidence and Registration

Step 4 sets up the quality management system of MDR Article 10(9) or IVDR Article 10(8), and steps 5 and 6 produce what it governs: the technical documentation of Annexes II and III (MDR and IVDR Article 10(4)) and the evidence.

MDR devices need clinical evaluation under MDR Article 61 and Annex XIV; IVDs need performance evaluation under IVDR Article 56 and Annex XIII.

Step 7 assigns UDIs (MDR Articles 27 to 29, IVDR Articles 24 to 26) and registers in EUDAMED, where four modules (actor registration, UDI/device registration, notified bodies and certificates, market surveillance) have been mandatory since 28 May 2026 under Commission Decision (EU) 2025/2371 and Regulation (EU) 2024/1860, as of 6 November 2026. Manufacturers register as actors before placing a device on the market and, where a notified body is involved, before applying to it (MDR Article 31(1), IVDR Article 28(1)). IVD-specific requirements are set out in the guide to the IVDR (Regulation (EU) 2017/746).

Steps 8 to 11: Assessment, Market Entry and Ongoing Duties

Step 8 is the notified-body assessment where the route requires one, ending with a certificate (MDR Article 56, IVDR Article 51); step 9 is the EU declaration of conformity under MDR Article 19 or IVDR Article 17 (10 items in Annex IV of each) and the CE marking under MDR Article 20 or IVDR Article 18 (Annex V). Both follow the conformity assessment (MDR Article 10(6), IVDR Article 10(5)).

Step 10 runs post-market surveillance (MDR Articles 83 to 86, IVDR Articles 78 to 81) and vigilance (MDR Article 87, IVDR Article 82). Step 11 is the PRRC under MDR and IVDR Article 15: a relevant degree plus at least 1 year of regulatory or quality management experience, or 4 years of such experience. Alongside runs MDR and IVDR Article 10a, applicable since 10 January 2025 (Regulation (EU) 2024/1860): notice at least 6 months before an anticipated interruption or discontinuation of supply that could result in serious harm to patients or public health.

Where the Programme Stands in Time

As of 6 November 2026, the main programme dates for legacy devices have passed, two IVDR conditions remain open for class B and sterile class A legacy devices, and a new MDR certificate takes most notified bodies more than a year from the written agreement. MDR legacy devices needed a quality management system and a formal application by 26 May 2024 and a written agreement by 26 September 2024 (MDR Article 120(3c)(d) and (e)); all legacy IVDs needed a quality management system by 26 May 2025 (IVDR Article 110(3c)(d)).

The end dates these conditions protect are listed below.

  • MDR legacy devices: 31 December 2027 (class III, and class IIb implantable except the listed items) or 31 December 2028 (all others), only under the conditions of MDR Article 120(3c); see the MDR transition period page.
  • Legacy IVDs: 31 December 2027 (IVDD certificate, self-declared class D), 31 December 2028 (self-declared class C) and 31 December 2029 (self-declared class B and sterile class A), under IVDR Article 110 as amended by Regulation (EU) 2024/1860; see the IVDR transition periods page.

IVDR written agreements were due by 26 September 2025 (IVDD-certified devices, class D) and 26 September 2026 (class C). Class B and sterile class A legacy IVDs still need a formal application by 26 May 2027 (IVDR Article 110(3c)(e)(iii)) and a written agreement by 26 September 2027 (IVDR Article 110(3c)).

In the 20th notified-body survey, published by the Commission with data to 28 February 2026, 62 % of notified bodies need 13 to 18 months from written agreement to a new MDR quality management system certificate (30 % need 6 to 12 months); for quality management system plus product certificates, 51 % need 13 to 18 months and 31 % need 19 to 24 months. It counts 32,898 MDR applications and 18,010 certificates, and 3,418 IVDR applications and 2,318 certificates.

Implementing Regulation (EU) 2026/977 on notified-body quotations and timelines applies from 25 February 2027; under its Article 8(1), its Articles 1 to 3 do not apply to written agreements signed before that date.

Cost Drivers to Raise When Asking for Quotes

The cost of an MDR or IVDR programme depends on the device's class and route, the gaps in the existing technical documentation and clinical or performance evidence, the size of the quality management system work, and the post-market surveillance the class requires. Step 5 of the Commission's model asks for a cost and benefit analysis of the portfolio that bears in mind a possible upgrade of risk class, the new conformity assessment procedures, post-market surveillance and technical-documentation gaps. These factors become questions for every quote: the number of devices and generic device groups, the class, the route, the size of the evidence gap and the timing.

Each notified body publishes its own list of standard fees (MDR Article 50, IVDR Article 46). Dated fee examples and what drives them are on the page on notified body fees and timelines.

Four Detailed Programme Pages

Four pages go deeper into the programme: an obligation-by-obligation checklist, the method of a gap analysis, what consultants do and how to compare their offers, and the training each role needs. Each of the four rows below names the page, its question and its legal hook.

Page What it answers Legal hook
EU MDR compliance checklist Every obligation with its article and evidence MDR Article 10(1) to (16), 10a; IVDR Article 10(1) to (15), 10a
MDR and IVDR gap analysis Method, scope and deliverables Implementation Model step 2
MDR and IVDR consultants What consultants do, comparing offers, cost Not defined in the MDR or the IVDR
MDR and IVDR training Course types and who needs what Implementation Model step 8; MDR and IVDR Article 15(1)

The Pending Commission Proposal

The Commission proposed a targeted revision of both regulations on 16 December 2025 (COM(2025) 1023, procedure 2025/0404(COD)); as of 6 November 2026 it is pending, at the stage "Awaiting committee decision" in the European Parliament's SANT committee, and it is not law. Every current rule on this page applies until an amending regulation is adopted and published; the past procedural events include the SANT draft report of 30 June 2026.

The proposal contains no extension of the legacy end dates. Every amending act and the proposal's stage are listed under MDR and IVDR amendments.

What a Compliance Programme Does Not Settle

A programme organises the work; it does not replace the conformity assessment, and older guidance documents can carry dates that later amendments replaced.

Superseded Dates in Older Commission Material

The Commission's factsheet for manufacturers is still online, but its statement that legacy devices may be placed on the market until 26 May 2024 and made available until 26 May 2025 was superseded by Regulation (EU) 2023/607, which removed the sell-off date (MDR Article 120(4), IVDR Article 110(4)). The Implementation Model of 1 August 2020 also predates Regulation (EU) 2023/607.

Indicative Results, Not Formal Decisions

This page and the class finder explain what the regulations require and give indicative results with the legal basis. They never decide whether a named manufacturer's product is a device or falls in a given class.

Sources