MDR and the Ecosystem of European Regulatory Sources

Regulation (EU) 2017/745 (MDR) represents the regulatory pillar for medical devices in Europe. However, the Regulation does not contain all references and does not directly link to the complex ecosystem of regulatory, technical, and interpretative sources that complete, modify, explain, and expand its content.

1. Blue Guide: fundamental guidance

The Blue Guide on the implementation of EU product rules (currently the 2022 version) is a guidance document published by the European Commission. Although it is not a legally binding instrument (only the texts of EU harmonization acts have the force of law), its purpose is to facilitate understanding of EU product legislation in order to ensure its uniform and consistent application throughout the single market.

In the context of medical devices, the Blue Guide provides crucial interpretations on:

• The “New Legislative Framework” (NLF): it explains in detail the concepts of harmonization, conformity assessment, CE marking, and the accreditation and market surveillance system.
• Economic Operators: it clarifies horizontally the roles, rights, and responsibilities of the various actors in the supply chain, defining exactly what is meant by manufacturer, authorized representative, importer, and distributor, and when an entity assumes the responsibilities of a manufacturer.
• Key concepts of circulation: it clarifies fundamental concepts also applicable to the MDR, such as making available on the market, placing on the market, and the rules for distance sales (e-commerce) and for imports from non-EU countries.

We have decided to cite the Blue Guide as the primary source because many aspects of the MDR can only be fully understood when read in conjunction with this guide.

2. MDR: legal basis of the system

The Medical Device Regulation is binding in all Member States and represents the main and legally binding legislative text establishing the rules for the placing on the market, making available, and putting into service of medical devices for human use and their accessories.

It is a directly applicable European regulation, adopted by the Parliament and the Council according to the ordinary legislative procedure.
It defines the concepts, roles, and responsibilities of the economic operators involved, establishes general safety and performance requirements, classification rules, conformity assessment processes for medical devices, post-market surveillance requirements, traceability aspects, and the strengthening of the clinical basis.

3. Amending Regulations: Changes to the Law

Amending regulations are legislative acts, adopted by the Parliament and the Council, published in the Official Journal of the EU (OJ) and legally binding, just like the MDR.
They intervene to alter or supplement the original text of the MDR, often to respond to emergencies or to adjust transition timelines.

As a non-exhaustive example, but with the aim of understanding cases where the intervention of an amending regulation is necessary, the following can be cited:

• Regulation (EU) 2020/561, which postponed the date of application of the MDR from 2020 to May 26, 2021, due to the COVID-19 pandemic.
• Regulation (EU) 2023/607, which extended the transitional periods for “legacy” devices (certified under the previous MDD/AIMDD directives) and removed the “sell-off” periods.
• Regulation (EU) 2024/1860, which introduced the obligation to provide timely information in the event of interruption or discontinuation of the supply of certain critical devices and regulated the gradual implementation of Eudamed.

4. Delegated Acts: Controlled Technical Updates

Delegated acts allow the Commission to amend non-essential elements of the MDR. These are non-legislative acts adopted by the European Commission (pursuant to Article 115 of the MDR), subject to review by the European Parliament and the Council, and published in the Official Journal (OJ).
They allow for the necessary flexibility to make amendments without reopening the entire legislative process.

They are typically used for updating annexes or for technical adjustments, including but not limited to:

• The adoption of specific rules for “highly individualized devices,” such as Delegated Regulation (EU) 2023/2197 (and the subsequent amendment 2025/788) regulating the assignment of the “Master UDI-DI” for contact lenses.
• Delegated Regulation (EU) 2025/1920 regarding the assignment of the UDI for spectacle frames, spectacle lenses, and ready-to-wear reading glasses.

5. Implementing Acts: Uniform Application

Implementing acts are acts adopted by the Commission to ensure uniform conditions for the implementation of the Regulation within the Member States. They are adopted by the Commission, involve committees of Member States, and are published in the OJ. Common Specifications are adopted through implementing acts.

Implementing acts do not change the law but govern its practical application.

Examples of published implementing acts:

• Implementing Regulation (EU) 2021/2226, which defines the methods and conditions for providing instructions for use (IFU) in electronic format instead of paper.
• Implementing Regulation (EU) 2022/2347, which reclassifies specific groups of active products without an intended medical purpose (e.g., liposuction equipment or hair removal lasers) into higher risk classes.

6. Common Specifications (CS): Binding Technical Requirements

Common Specifications (CS) are a set of technical and/or clinical requirements, other than harmonized standards, that allow for compliance with applicable legal obligations. The Commission adopts them through implementing acts when harmonized standards do not exist or are insufficient. Devices compliant with CS benefit from a presumption of conformity with the requirements of the Regulation that such CS cover.

For example, Implementing Regulation (EU) 2022/2346 establishes exclusive common specifications for product groups that do not have an intended medical purpose (listed in Annex XVI of the MDR), such as dermal fillers, tattoo removal lasers, or contact lenses for purely aesthetic purposes.

7. Harmonized Standards Published in the Official Journal: Presumption of Conformity

Technical standards are developed to provide specific solutions to meet the essential requirements of the legislation. It is fundamental to distinguish between two statuses for these standards:

• Status 1 – Harmonized standard (not yet published in the Official Journal): a European standard becomes “harmonized” when it is adopted by European standardization organizations (such as CEN and CENELEC) based on a specific request (mandate) from the European Commission. Harmonized standards are completed by “Annexes Z” which map the paragraphs of the standard to the requirements of the MDR. However, until the reference of such a standard is published in the Official Journal, it does not confer the presumption of conformity with legal requirements.
• Status 2 – Harmonized standard published in the Official Journal: only when the references of the harmonized standard are published in the Official Journal of the European Union (via Commission Implementing Decisions) do devices that comply with it enjoy the presumption of legal conformity with the MDR requirements covered by it. The application of standards remains always voluntary; the manufacturer may choose other specifications, but in such cases, the burden of proof of conformity rests entirely with them.

8. MDCG: Interpretation

The Medical Device Coordination Group (MDCG), established by Art. 103 of the MDR; it drafts guidance documents and guidelines to ensure the uniform and harmonized application of the MDR.

These documents are not legally binding, but they represent the interpretative “state of the art” and the best practices recognized by the Commission, Member States, and notified bodies.

9. National law of member states

Although Regulation (EU) 2017/745 (MDR) is directly applicable in all Member States, the medical device sector continues to be heavily influenced by national law. In fact, the MDR does not fully harmonize all regulatory aspects, leaving Member States with significant competencies regarding market surveillance, the sanctions regime, medical device advertising, language requirements, vigilance, the organization of competent authorities, and local procedural provisions.

In Italy, the main reference is represented by Legislative Decree No. 137 of August 5, 2022 137, providing “Provisions for the adaptation of national legislation to the provisions of Regulation (EU) 2017/745”. The decree regulates, among other aspects, the applicable sanctions, the competencies of the Ministry of Health, control and vigilance activities, as well as certain profiles relating to healthcare advertising and the obligations of economic operators.

For this reason, a correct interpretation of the regulatory framework cannot be limited solely to European sources, but must necessarily also consider national legislation—in the countries of interest—and the application practices of individual competent authorities.

10. State of the art

Finally, there are a series of further references that effectively alter, interpret, and complete the already broad framework of regulatory sources governing the medical device sector:

• National competent authorities may provide circulars, local interpretations, FAQs, and position papers, influencing the practical application of the MDR (as in the case of the controversial Ministry of Health document “Guidelines for reporting complaints on medical devices” distributed with the Circular of June 6, 2023 (prot. 47854))
• Notified bodies have their own regulations and use their own guidelines and checklists which—from an extremely practical point of view—decisively influence the application criteria and interpretation of all the sources cited above: what the notified body accepts becomes a “regulatory reality.”
• Non-harmonized standards, although they do not provide a presumption of conformity with the Regulation, contribute to defining the state of the art and cannot be entirely ignored, especially in the absence of a harmonized equivalent.
• International guidelines attributable to the International Medical Device Regulators Forum (IMDRF) or—more rarely, but possible—to the World Health Organization (WHO).
• Finally, position papers, recommendations, and interpretations from industry associations such as, in order of impact:
  • Team-NB, a forum that brings together some—not all—of the European notified bodies. It is a non-institutional industry group that produces position papers, technical recommendations, and shared interpretations among the bodies themselves. If multiple bodies share the same interpretation, that inevitably becomes a standard.
  • NBOG (Notified Bodies Operations Group), a European group composed of representatives of competent authorities and experts involved in the supervision of notified bodies. It is not a legislative body and does not issue binding rules, but although it was established under the MDD directive and is now less central than the MDCG, it has been very influential and some of its documents are still used as references.
    

Hierarchy of Sources and Conclusions

While the legal hierarchy may seem linear (MDR, amending regulations, acts), the operational—and therefore real—hierarchy presents multiple sources, often difficult to monitor but essential within a conformity assessment process:

1. Blue Guide
2. MDR
3. Amending regulations
4. EU delegated acts
5. EU implementing acts
6. CS
7. Harmonized standards
8. MDCG
9. National law of member states
10. State of the art

The MDR system is a complex ecosystem that combines law (EU regulations and acts), technique (norms and standards), interpretation (MDCG), and practice (NB and authorities). No single source is sufficient. To operate correctly, it is necessary to monitor all sources, know how to integrate them, understand their role, and apply them consistently.

For this reason, we have structured a page that summarizes on a monthly basis all updates and new publications attributable to the sources summarized above. The intent is to enable the up-to-date management of the conformity assessment and post-market surveillance process.