Regulatory framework overview
Both MDR 2017/745 and IVDR 2017/746
This site provides general information only and does not constitute legal or regulatory advice. Always consult the official regulation text and qualified regulatory professionals.
From directives to regulations
EU medical device law underwent a fundamental overhaul when the European Commission replaced three directives with two directly applicable regulations:
| Old legislation (directives) | New legislation (regulations) | Date of application |
|---|---|---|
| Medical Devices Directive 93/42/EEC (MDD) | MDR 2017/745 | 26 May 2021 |
| Active Implantable Medical Devices Directive 90/385/EEC (AIMDD) | MDR 2017/745 (AIMDs are now Class III) | 26 May 2021 |
| In Vitro Diagnostic Directive 98/79/EC (IVDD) | IVDR 2017/746 | 26 May 2022 |
Unlike directives, regulations are directly applicable in all EU member states without national transposition — a deliberate choice to ensure uniform application across the EU single market.
The regulatory architecture
The regulations sit at the top of a layered legislative framework:
Regulation (EU) 2017/745 (MDR) + Regulation (EU) 2017/746 (IVDR)
│
├── Implementing acts (European Commission)
│ ├── EUDAMED implementing regulation
│ ├── UDI implementing regulation
│ └── Other implementing measures
│
├── Delegated acts (European Commission)
│ ├── Annex XVI updates (non-medical purpose devices)
│ └── Classification rule amendments
│
├── Common Specifications (CS)
│ ├── Device-specific technical and clinical requirements
│ └── Substitute for harmonised standards where none exist
│
└── Harmonised European Standards (CEN/CENELEC, ISO, IEC)
└── Compliance creates a presumption of conformity
with corresponding MDR/IVDR requirements
Key actors in the system
European Commission (EC)
The EC issues implementing and delegated acts, publishes Common Specifications, chairs the MDCG, and manages EUDAMED — the central EU medical device database.
Medical Device Coordination Group (MDCG)
The MDCG is composed of representatives from all EU member states and chaired by the European Commission. Its roles include:
- Issuing non-binding guidance documents (the MDCG guidance series)
- Advising on borderline and classification questions
- Designating and monitoring notified bodies
- Coordinating vigilance and post-market activities across member states
MDCG guidance is not legally binding but represents the authoritative interpretation of MDR/IVDR requirements and is followed by notified bodies and competent authorities.
National Competent Authorities (NCAs)
Each member state has a designated NCA responsible for:
- Authorising clinical investigations
- Receiving and acting on vigilance reports
- Conducting market surveillance and inspections
- Consulting on borderline and classification questions
| Country | Competent Authority |
|---|---|
| Germany | BfArM |
| France | ANSM |
| Netherlands | IGJ |
| Italy | Ministero della Salute |
| Sweden | MPA (Läkemedelsverket) |
| Ireland | HPRA |
A full list is maintained on the European Commission website.
Notified Bodies (NBs)
Notified bodies are private, third-party conformity assessment organisations designated by NCAs and supervised by the MDCG. They are authorised to assess manufacturer conformity for devices that cannot self-declare. They:
- Review technical documentation and quality management systems
- Issue EU certificates that underpin CE marking
- Conduct announced and unannounced audits
- Are listed in the NANDO database
The number of MDR/IVDR-designated notified bodies is significantly lower than under the old directives, creating capacity constraints that affect application timelines.
European Medicines Agency (EMA)
EMA becomes relevant where devices interact with medicinal products:
- Drug-device combination products (integral) — EMA for the drug substance component
- Companion diagnostics under IVDR — EMA provides a mandatory scientific opinion
How CE marking works
EU medical device regulation is a conformity assessment system, not a pre-market approval system. The manufacturer — not the regulator — places the CE mark, after satisfying themselves (and in many cases a notified body) that all applicable requirements are met:
- Design and manufacture the device to meet all applicable requirements (GSPR, QMS, technical documentation)
- Conduct conformity assessment — self-declaration for lower-risk classes; notified body involvement for higher-risk classes
- Sign an EU Declaration of Conformity attesting to compliance
- Affix the CE mark — device can be placed on the EU market
- Post-market obligations begin — PMS, vigilance reporting, EUDAMED registration
The CE mark signals regulatory compliance, not product quality or clinical superiority.
CE marking under the old MDD/AIMDD/IVDD is not equivalent to CE marking under MDR/IVDR. Transitional provisions governed the wind-down of old certificates. See Transitional provisions & timelines.
EUDAMED
EUDAMED (European Database on Medical Devices) is the central information infrastructure underpinning MDR and IVDR. Its six modules cover:
| Module | Key content |
|---|---|
| Actor registration | Economic operators; issues Single Registration Numbers (SRNs) |
| UDI / Device registration | UDI-DI and device characteristics for all placed devices |
| Notified body & certificates | NB designations and all issued, suspended, or withdrawn certificates |
| Clinical investigations | Registration and reporting of clinical investigations and performance studies |
| Vigilance | Serious incidents, field safety corrective actions, trend reports |
| Market surveillance | Competent authority actions, safeguard procedures |
Some modules are publicly accessible; others are restricted to registered economic operators, notified bodies, and competent authorities.
Harmonised standards and Common Specifications
Harmonised standards are European standards (EN ISO, EN IEC) developed under a Commission mandate. Compliance with a harmonised standard that covers specific MDR/IVDR requirements creates a presumption of conformity with those requirements — reducing the documentation burden for demonstrating compliance.
Key harmonised standards relevant to MDR/IVDR include:
| Standard | Subject |
|---|---|
| EN ISO 13485:2016 | Quality management systems |
| EN ISO 14971:2019 | Risk management |
| EN ISO 10993 series | Biological evaluation |
| EN 62304:2006+A1:2015 | Medical device software lifecycle |
| EN ISO 15223-1 | Symbols for labelling |
Where no harmonised standard exists or is insufficient, the Commission may publish Common Specifications (CS) — binding technical or clinical requirements that manufacturers must meet or demonstrably justify departing from.
Relationship with non-EU systems
| Jurisdiction | System | Relationship to MDR/IVDR |
|---|---|---|
| UK | UKCA marking (UK MDR 2002, as amended) | Separate system post-Brexit; MRA not yet updated |
| USA | FDA 21 CFR (510(k), PMA, De Novo) | No mutual recognition; separate pathway |
| Switzerland | MedDO (Medizinprodukteverordnung) | MRA update pending; currently diverging |
| Australia | TGA (Therapeutic Goods Act 1989) | No MRA; separate ARTG inclusion required |
The MDR/IVDR do not have an equivalence approval pathway analogous to FDA's 510(k). The equivalent device concept in MDR Art. 61 is a tool for accessing clinical data to support a clinical evaluation — not a route to market in itself.
Related pages
- Who needs to comply?
- Lifecycle of a medical device
- Transitional provisions & timelines
- Legislation — MDR key articles
- Legislation — IVDR key articles
- Notified bodies
- EUDAMED registration
Official references
| Reference | Description |
|---|---|
| MDR Recitals 1–30 | Legislative background and objectives |
| MDR Art. 36–50 | Notified body framework |
| MDR Art. 78–83 | MDCG and competent authorities |
| MDR Art. 100–105 | EUDAMED |
| MDR Art. 8 | Presumption of conformity from harmonised standards |
| MDR Art. 9 | Common Specifications |
| IVDR Arts. 8–9 | Equivalent IVDR provisions |