What is Rule 11 under EU MDR?

Rule 11 classifies software intended to provide information used for decisions with diagnostic or therapeutic purposes. Most such software is Class IIa or higher, with Class III applied when decisions may cause death or irreversible deterioration.

What are the MDR transition deadlines?

Regulation (EU) 2023/607 extended MDD certificates: Class III and implantable Class IIb through 31 December 2027, and Class IIa, Class IIb non-implantable, and Class I devices requiring Notified Body involvement through 31 December 2028, provided manufacturers have applied to a Notified Body by set deadlines and meet other conditions.

Do I need a Notified Body under MDR?

Yes for every device above Class I. Class I sterile, measuring, and reusable surgical devices also require Notified Body involvement (for the sterility, metrology, or reprocessing aspects respectively).

All terms

RegulatoryRegulated Pathways Global MarketsMDR

EU Medical Device Regulation

Regulation (EU) 2017/745 governing medical devices in the European Union.

Reviewed by Christian Espinosa, Founder, Blue Goat CyberLast reviewed May 5, 2026

Definition

Regulation (EU) 2017/745 (MDR) lays down rules concerning the placing on the market, making available, and putting into service of medical devices for human use and accessories, replacing the previous Medical Devices Directive (MDD).

What this means in practice

MDR introduces stricter clinical evidence requirements, stronger post-market surveillance, UDI, EUDAMED registration, and an enhanced role for Notified Bodies. Many devices have undergone reclassification, especially software (Rule 11 pushes most standalone medical software to Class IIa or higher). Transitional provisions extended MDD certificate validity for legacy devices through May 2027 (Class III and implantable Class IIb) and December 2028 (other classes) provided conditions in Regulation (EU) 2023/607 are met.

Examples

A Class IIa mobile app for insulin dose calculation that would have been Class I under the MDD, reclassified under MDR Rule 11.
A legacy implantable cardiac device sold under an MDD certificate, extended through May 2027 under the Regulation (EU) 2023/607 transition, with a Notified Body application filed by the required deadline.

Use cases

1 scenario

Class IIb device transitioning from MDD to EU MDR

Regulatory & Clinical

The manufacturer expands clinical evaluation, refreshes the technical file to MDR Annex II/III, signs a notified body contract, and registers the device and economic operators in EUDAMED.

OutcomeCE marking under MDR is issued before the legacy MDD certificate expires, avoiding a supply gap.

Common pitfalls

•Assuming Rule 11 does not apply. Most software providing information used for decisions with a diagnostic or therapeutic purpose is now Class IIa or higher.
•Missing the transition deadlines and Notified Body application windows in Regulation (EU) 2023/607.
•Under-scoping clinical evidence. MDR expects a Clinical Evaluation Plan and ongoing Post-Market Clinical Follow-up (PMCF), not a one-time literature review.
•Treating a Person Responsible for Regulatory Compliance (PRRC) role as optional. It is mandatory for manufacturers and authorized representatives.

Frequently asked questions

MDR (Regulation (EU) 2017/745) replaced the Medical Devices Directive (93/42/EEC) in 2021. Key changes: stricter clinical evidence, mandatory UDI and EUDAMED registration, reclassification of many devices (especially software under Rule 11), lifecycle post-market surveillance, and a PRRC role.

Cross-references

Uses

Concepts or artefacts this term builds on.

Contains

Sub-elements or required artefacts of this term.

Often confused with

Distinct concept frequently mistaken for this one.

EU In Vitro Diagnostic Regulation(IVDR)
MDR covers devices; IVDR covers in-vitro diagnostics.

Shared paths + category

Regulatory

EU In Vitro Diagnostic Regulation(IVDR)

Regulation (EU) 2017/746 governing in vitro diagnostic medical devices in the EU.

EU MDR Essentials · adjacent

Regulatory

CE Mark

Mandatory European conformity mark for medical devices placed on the EU market.

EU MDR Essentials

Regulatory

EUDAMED

European Database on Medical Devices.

EU MDR Essentials

Regulatory

Notified Body(NB)

EU-designated organization that assesses conformity of medical devices under MDR and IVDR.

EU MDR Essentials

Regulatory

Unique Device Identification(UDI)

System for adequate identification of medical devices through distribution and use.

EU MDR Essentials

Regulatory

Medical Device Coordination Group Guidance(MDCG)

Guidance documents from the EU-level expert group that interpret MDR/IVDR requirements.

Same category

Latest in MedTech

Primary references

3 sources

Link health: 2 verified 1 unchecked· last checked 2026-06-20

EUR-Lex·2European Commission·1

Inline markers like [1] jump to the matching reference above.

On this term

Category: Regulatory
Acronym: MDR
Sources: 3
Use cases: 1
Updated: 5/5/2026

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Learn in 60 seconds

Regulation (EU) 2017/745 governing medical devices in the European Union.

·MDR introduces stricter clinical evidence requirements, stronger post-market surveillance, UDI, EUDAMED registration, and an enhanced role for Notified Bodies.
·Many devices have undergone reclassification, especially software (Rule 11 pushes most standalone medical software to Class IIa or higher).

Remember this

Watch out: Assuming Rule 11 does not apply. Most software providing information used for decisions with a diagnostic or therapeutic purpose is now Class IIa or higher.

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