EU Medical Device Regulatory Framework: MDR, IVDR and the MDCG Guidance Structure
This domain tests whether you can place any device question inside the correct legal instrument and separate binding law from interpretive guidance. In a pre-registration assessment you are expected to cite the article or annex that creates the obligation, and to know which economic operator carries it.
Two regulations, not directives
The MDR (EU) 2017/745 replaced Directive 93/42/EEC and Directive 90/385/EEC; the IVDR (EU) 2017/746 replaced Directive 98/79/EC. Because both are regulations they apply directly in every Member State without national transposition, and national law may only add where the regulation explicitly allows. The MDR entered into force on 17 May 2017 and has applied since 26 May 2021. The IVDR entered into force on 25 May 2017 and has applied since 26 May 2022.
What binds and what guides
Binding layers are the articles, the annexes (Annex I general safety and performance requirements, Annex VIII classification, Annexes IX to XI conformity assessment), delegated and implementing acts, and common specifications adopted under Article 9, which are binding where they exist. Harmonised standards give presumption of conformity but remain voluntary. MDCG guidance, position papers and Q&A are not legally binding; they state the coordinators' agreed reading, and a departure must be justified in the technical documentation.
Operators and duties
Article 10 sets the manufacturer's obligations, Article 11 the authorised representative, Article 13 the importer and Article 14 the distributor; Article 15 requires a person responsible for regulatory compliance at manufacturers, authorised representatives and importers. Article 16 lists when a distributor or importer takes on manufacturer obligations.
Worked example
A file states that a Class IIa device's labelling follows MDCG 2021-24 and that the documentation is complete because that guidance requires it. This loses marks twice: MDCG 2021-24 addresses classification, not labelling, and guidance cannot create requirements. The correct citations are Annex I Chapter III for labelling and Annex VIII for classification, with the guidance used only as interpretation.
Traps
Treating entry into force as the date of application; assuming guidance binds; assuming Directive-style transposition is still needed; forgetting that Article 9 common specifications override standards; and mixing IVDR obligations into an MDR device assessment.