Medical Device Standards: MDR, IVDR and Harmonised References

Medical-device regulations and technical standards have different roles. Start with the product's intended purpose and regulatory classification, then identify the requirements and evidence relevant to that device.

Use the correct EU references

The Medical Devices Regulation is Regulation (EU) 2017/745, usually called the MDR. The In Vitro Diagnostic Medical Devices Regulation is Regulation (EU) 2017/746, or IVDR. The European Commission's regulatory overview provides the framework and links to further guidance.

What harmonised standards contribute

A standard is not automatically a harmonised reference for a regulation because it concerns healthcare. The Commission publishes references in the EU Official Journal. Voluntary use of a cited standard can provide presumption of conformity for the requirements it covers, within the applicable citation and its limits.

Check the Commission's medical-device harmonised-standards page for the relevant regulation and publications. Record the exact standard edition and amendments rather than relying on its number alone.

Keep the evidence categories distinct

  • Product evidence: assessments and documentation relating to the actual device and intended purpose.
  • Management-system evidence: how the organisation manages relevant processes, for example within an ISO 13485 system.
  • Regulatory assessment: the applicable route and obligations under the relevant legislation.

A management-system certificate does not by itself authorise every device for sale. Nor does one standards-based test establish that every applicable requirement has been met.

For broader subject navigation, see the European-Standards.com healthcare standards overview. Use the Commission's current references for regulatory citation checks.

Reviewed 26 September 2026.

Comments

Post a Comment

Popular posts from this blog

IEC 62321: Substance Testing, Screening and RoHS Evidence

Image
The IEC 62321 series provides methods for determining specified substances in electrotechnical products. Its European adoptions can support a materials assessment, but a test method is not itself a legal substance limit or a complete compliance assessment. Choose the method for the substance and material The Genorma collection's inventory includes sample preparation, screening and substance-specific analytical methods. Check each document's designation: some are EN adoptions, while the listing also includes an IEC publication. Part 2: disassembly and mechanical preparation of samples. Part 3-1: XRF screening for lead, mercury, cadmium, total chromium and total bromine. Parts 6 and 7: methods addressing specified brominated flame retardants and hexavalent chromium respectively. Part 8: methods for specified phthalates in polymers. A screening result needs interpretation Total chromium is not the same measurement as hexavalent chromium. Likewise, total bromine does not ident...
Read more

What Does prEN Mean? Draft Standards and Placeholder References

prEN means draft European Standard. It identifies a document under development, rather than a published EN. CEN and CENELEC distinguish draft standards (prENs) from European Standards (ENs) . Does “prEN 50XXX” identify a particular standard? Not on its own. “50XXX” is a placeholder-style reference, so it cannot establish a document's technical subject or requirements without its project context. Such references can appear in genuine work programmes; they should not be mistaken for a uniquely identified published standard. The specific catalogue example The Genorma record linked by this article describes a project to revise DIN 47624:1980-04 concerning plastic clamping closures for telecommunication cables with metallic conductors and optical fibres. The indexed catalogue record identifies the project as abandoned, with deletion dated 7 July 2000. It should not be presented as an upcoming standard or a new binding requirement. How to verify a draft reference Find the full title a...
Read more

Eurocode Package 10: Towers, Masts, Piling and Cranes

Image
Genorma's Eurocode standards package 10 covers towers, masts, chimneys, piling and crane-supporting structures. The seller's package number is a catalogue label, not the official Eurocode 10 designation. Its listed documents come from Eurocode 3 and Eurocode 8. Documents listed by the seller EN 1993-3-1: steel towers and masts. EN 1993-3-2: steel chimneys. EN 1993-5: steel piling. EN 1993-6: structures supporting cranes. EN 1998-6: earthquake-related provisions for towers, masts and chimneys. The listing identifies BDS national editions of these documents. Their presence in a bundle does not establish that every document, edition or design method applies to the same project. Build a project-specific document list Begin with the structure and its intended use. Record which references the specification requires, then confirm their editions, amendments, national adoption and any relevant National Annex. Check whether newer documents affect the intended design basis. Loading...
Read more