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How to read EU legislation

Applies to

Both MDR 2017/745 and IVDR 2017/746, and all EU implementing and delegated acts.

EU legislative hierarchy — a quick map​

Understanding which type of EU legal act you are reading is essential to understanding its authority and how it can be changed:

TypeMade byBinding?Can be amended by
RegulationParliament + CouncilYes — directly applicable in all MSNew regulation from Parliament + Council
DirectiveParliament + CouncilYes — but requires national transpositionNew directive
Implementing actCommissionYesNew implementing act from Commission
Delegated actCommission (under Parliament/Council mandate)YesNew delegated act (subject to Parliament/Council objection)
MDCG guidanceMDCGNo — persuasive onlyNew MDCG guidance
Harmonised standardCEN/CENELEC (under Commission mandate)No — creates presumption of conformityRevised standard

Anatomy of a regulation — MDR as example​

The preamble (recitals)​

Before the articles, every EU regulation has numbered recitals (paragraphs beginning with "Whereas..."). These are not legally binding but explain the legislative intent and context. When interpreting an ambiguous article, recitals provide interpretive guidance.

MDR has 125 recitals. Key ones include:

  • Recital 1: Why MDR replaces MDD/AIMDD
  • Recital 38: The CE mark as a regulatory statement, not a quality mark
  • Recital 61: The importance of clinical evaluation as a lifecycle process

The articles​

The substantive law. Each article has a number and — unlike some other legal systems — EU regulations typically use descriptive headings for each article, making navigation easier.

Articles are divided into paragraphs (numbered) and sometimes sub-paragraphs (lettered). Citation format: MDR Art. 61(4)(b) means Article 61, paragraph 4, sub-paragraph (b).

The annexes​

Detailed technical, procedural, and administrative requirements. Annexes have the same legal force as the articles but contain the operational detail. Many articles simply refer to an annex: "the technical documentation shall include the elements set out in Annex II."

Finding the current text — consolidated versions​

EU regulations are amended over time by amending regulations. The official consolidated text incorporates all amendments and is the version to use for compliance purposes.

Sources:

  • EUR-Lex (eur-lex.europa.eu): official EU law database. Search for "32017R0745" (MDR) or "32017R0746" (IVDR). Select "HTML" or "PDF" under "Consolidated version."
  • Official Journal of the EU (OJ): original and amending regulations. OJ L (legislation series) is where device regulations are published.
caution

Do not rely on unamended original versions — both MDR and IVDR have been significantly amended. Always use the consolidated version.

Tracking amendments to MDR and IVDR​

AmendmentEffect
Regulation (EU) 2020/561Delayed MDR application date from May 2020 to May 2021 (COVID-19)
Regulation (EU) 2022/112Extended IVDR transitional provisions
Regulation (EU) 2023/607Extended MDR transitional provisions; introduced sell-through provisions
Regulation (EU) 2024/1860Further extended IVDR transitional provisions

Reading MDCG guidance — what it is and is not​

MDCG guidance is published by the Medical Device Coordination Group. It provides the Commission's and member states' interpretation of MDR/IVDR requirements. It is:

  • Not legally binding — MDCG guidance does not have the force of law
  • Highly influential — notified bodies and NCAs follow MDCG guidance; departing from it requires justification
  • Updated regularly — guidance is revised as questions arise and the regulatory landscape evolves

MDCG guidance documents are numbered (e.g. MDCG 2020-5) and available on the Commission's DG SANTE website.

Official references​

ReferenceDescription
EUR-LexEU law database — eur-lex.europa.eu
OJ L 117, 5.5.2017MDR and IVDR original publication
DG SANTEMDCG guidance — ec.europa.eu/health/medical-devices