Implementing acts, delegated acts, Common Specifications & harmonised standards
The legislative framework beneath MDR and IVDR comprises implementing acts (Commission), delegated acts (Commission), Common Specifications (Commission via implementing act), and harmonised European standards (CEN/CENELEC under Commission mandate).
This page provides an overview. Always verify the current status of specific acts and standards in the Official Journal of the EU and the EU harmonised standards database.
The four-layer framework
MDR 2017/745 / IVDR 2017/746 ← Primary law (Parliament & Council)
↓
Implementing & delegated acts ← Secondary law (Commission)
↓
Common Specifications ← Technical requirements (Commission via implementing act)
↓
Harmonised standards ← Technical standards (CEN/CENELEC, ISO, IEC)
Each layer provides more granular technical detail than the one above it, without the primary law needing to be amended.
Implementing acts
Implementing acts are adopted by the European Commission to specify the practical application of MDR/IVDR requirements. They are legally binding and published in the Official Journal.
Key implementing acts under MDR/IVDR
| Implementing Act | Subject |
|---|---|
| Commission Implementing Regulation (EU) 2017/2185 | List of issuing entities for UDI (GS1, HIBCC, ICCBBA) |
| Commission Implementing Regulation (EU) 2021/2226 | Requirements for electronic instructions for use |
| Commission Implementing Regulation (EU) 2022/2346 | Common specifications for Annex XVI devices (group 1 — contact lenses, dermal fillers, lipolysis equipment) |
| Commission Implementing Regulation (EU) 2022/2347 | Classification of certain active optical instruments (Annex VIII Rule 22 amendment) |
| Commission Implementing Decision 2019/939 | Designation of EUDAMED implementing regulation (structure and content) |
The Commission may also adopt implementing acts to:
- Establish or update the list of harmonised standards
- Specify EUDAMED technical requirements
- Define formats for clinical investigation applications
- Issue reclassification decisions for specific device categories
Delegated acts
Delegated acts allow the Commission to amend or supplement non-essential elements of MDR/IVDR. They require a mandate in the primary regulation and can be objected to by Parliament or Council.
Key delegated powers in MDR
| Article | Subject of delegation |
|---|---|
| MDR Art. 1(2) | Amend Annex XVI (add new non-medical purpose device categories) |
| MDR Art. 51(2) | Reclassify specific devices or categories |
| MDR Art. 53 | Amend Annex VIII (classification rules) |
| MDR Art. 56(3) | Amend Annexes IX–XI (conformity assessment procedures) |
Common Specifications (CS)
Common Specifications are a form of implementing act that specifies technical and/or clinical requirements for specific device types or categories. They are published in the Official Journal and:
- Create the same presumption of conformity as harmonised standards where they cover the same GSPR
- Are binding unless the manufacturer can justify an equivalent or better approach
- Are prioritised by the Commission where no harmonised standard exists or is adequate
Published and in-development Common Specifications
| CS | Device/analyte category | Status |
|---|---|---|
| Commission Implementing Regulation (EU) 2022/2346 | Annex XVI Group 1 (contact lenses, dermal fillers, lipolysis, laser/IPL) | Published |
| CS for specific IVDs (IVDR) | HIV, HCV, HBV, blood group typing, and other Class D analytes | In development |
| CS for legacy implants | Specific implantable device categories needing clinical evidence guidance | In development |
Manufacturers should monitor the Commission's CS work programme — published on DG SANTE's website.
Harmonised standards
Harmonised European standards are standards developed by CEN or CENELEC (or adopted from ISO/IEC) under a standardisation mandate from the European Commission. Once harmonised under MDR/IVDR:
- A manufacturer complying with the standard has a presumption of conformity with the MDR/IVDR requirements covered by the standard
- The standard's harmonised references are published in the Official Journal of the EU
Important notes on harmonisation status
Not all relevant ISO/IEC/EN standards are harmonised under MDR/IVDR. The harmonised list under MDR/IVDR is shorter than under the old MDD/IVDD because:
- Harmonisation is a formal process that takes time
- Some standards were updated and the new versions are not yet harmonised
- New MDR-specific requirements have no corresponding standard yet
Always check the current harmonised standards list in the OJ before relying on a standard for presumption of conformity.
Key harmonised and widely-used standards
| Standard | Subject | MDR/IVDR GSPR |
|---|---|---|
| EN ISO 13485:2016 | Quality management systems | Art. 10(9) — QMS |
| EN ISO 14971:2019 | Risk management | GSPR §1–2 |
| EN ISO 10993-1:2018 | Biological evaluation — risk management | GSPR §6 |
| EN ISO 10993-5:2009 | In vitro cytotoxicity | GSPR §6 |
| EN ISO 10993-10:2021 | Skin sensitisation | GSPR §6 |
| EN 62304:2006+A1:2015 | Medical device software lifecycle | GSPR §17/21 |
| IEC 62366-1:2015+A1:2020 | Usability engineering | GSPR §5/17 |
| EN 60601-1:2006+A1:2013 | Medical electrical equipment safety | GSPR §14–16 |
| EN 60601-1-2:2015 | EMC for medical electrical equipment | GSPR §18 |
| EN ISO 15223-1:2021 | Symbols for labelling | GSPR §23 |
| EN ISO 11135:2014 | EtO sterilisation | GSPR §7 |
| EN ISO 11137-1:2015 | Radiation sterilisation | GSPR §7 |
| EN ISO 14155:2020 | GCP for medical device investigations | MDR Art. 62 |
How to read EU legislation
→ See How to read EU legislation
Official references
| Reference | Description |
|---|---|
| OJ C series | List of harmonised standards under MDR/IVDR |
| EUR-Lex | All EU implementing and delegated acts |
| DG SANTE website | CS work programme and status |
| CEN/CENELEC | European standardisation body |
Complete the final paragraph: 'A manufacturer complying with the standard has a presumption of conformity with the MDR/IVDR requirements that the standard covers. Non-compliance with a harmonised standard does not automatically mean non-compliance with the regulation, but the manufacturer must document an alternative means of meeting the applicable GSPR.'