EU MDR · Basic · 13 min lesson
MDR and IVDR orientation: economic operators, scope and the path to CE marking
Regulation (EU) 2017/745 Articles 1, 2, 10 to 16, 20, 52 and Annex VIII; Regulation (EU) 2017/746 Articles 10 to 15, 47, 48; transition under Regulations 2023/607 and 2024/1860
What you will learn
- Decide whether a product falls under the MDR, the IVDR or neither, using the definitions in Article 2 and the scope in Article 1.
- Name the duties of the manufacturer, authorised representative, importer, distributor and person responsible for regulatory compliance, and spot when a distributor becomes the manufacturer.
- Describe the ordered path from intended purpose to CE marking, including notified body involvement and the 2027 to 2029 transition dates for legacy devices.
Key takeaways
- Intended purpose under Article 2 decides scope: MDR product, IVDR product or neither.
- Five roles carry duties: manufacturer, authorised representative, importer, distributor and person responsible (Articles 10 to 15).
- Article 16 makes anyone who rebrands, changes purpose or modifies a device the manufacturer.
- The path runs purpose, class (Annex VIII), route (Article 52), Annex I, documentation, declaration, CE mark, UDI and registration.
- Legacy devices run to 31 December 2027 or 2028 under MDR and 2027 to 2029 under IVDR, only if conditions are met and evidenced.
Free practice question
Zenith Optics, a fictional firm in Canada, sells a handheld retinal camera that a clinician uses to photograph the back of the eye to detect disease. It has no EU office and wants to sell through a German reseller.
Which obligation applies first to Zenith before supply starts?
Appoint an authorised representative in the Union by a written mandate.
Correct. Article 11 of the MDR requires a manufacturer outside the Union to designate an authorised representative before placing devices on the market.
Let the German reseller affix the CE mark after arrival.
Not quite. Article 20 and Article 19 place declaration and marking with the manufacturer, so the reseller cannot substitute for it.
Wait for a customer complaint before choosing a representative.
Not quite. Article 11 is a precondition for placing on the market, so waiting for events conflicts with the MDR text.
Register only in Canada and rely on that approval.
Not quite. A Canadian approval is not recognised in place of CE marking under Article 52 and Article 10 of the MDR.
Key terms
- economic operator: Manufacturer, authorised representative, importer, distributor or other person with duties in the supply chain under the MDR and IVDR.
- authorised representative: A person established in the Union, mandated in writing by a non-EU manufacturer to act for it on defined tasks (MDR Article 11).
- person responsible for regulatory compliance: The person with defined expertise who ensures conformity checks, documentation, vigilance and declarations are in order (MDR Article 15).
- intended purpose: The use for which a device is intended according to the manufacturer data on label, instructions, promotional material and clinical evaluation.
- notified body: A conformity assessment body designated by a Member State to assess devices that need third party review.
- legacy device: A device placed on the market under the old directives that continues to be supplied under the MDR or IVDR transition provisions.
- UDI: The unique device identifier system that marks and tracks devices (MDR Article 27).
Official sources
- Regulation (EU) 2017/745 on medical devices (MDR), EUR-Lex
- Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR), EUR-Lex
- European Commission: Medical devices sector, new regulations and transition
Go further
The full lesson has narrated slides, more scenario questions with explained answers and a simulation.
Open the AcademyWatch on YouTubeIllustrative example. Educational only, not legal advice.