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).

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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 September 19, 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). The MDR replaced the Medical Devices Directive (93/42/EEC) and the Active Implantable Medical Devices Directive (90/385/EEC) and has applied since May 26, 2021. Key changes include stricter clinical evidence requirements, the PRRC role, UDI, expanded post-market surveillance and periodic safety update reports, tighter oversight of notified bodies and the EUDAMED database. Transition periods for legacy devices were extended by Regulation (EU) 2023/607.

What the regulation says

Regulation (EU) 2017/745 (MDR), adopted on 5 April 2017 and applicable since 26 May 2021, replaced Directives 93/42/EEC and 90/385/EEC. For MedTech manufacturers, Article 10 establishes general obligations, including quality management and technical documentation; Annex I sets general safety and performance requirements. Article 61 and Annex XIV govern clinical evaluation and post-market clinical follow-up. Article 15 requires a person responsible for regulatory compliance (PRRC), with specific arrangements for micro and small enterprises. Article 27 establishes unique device identification (UDI), while Article 33 provides for EUDAMED. Articles 35 to 50 govern notified body designation and oversight. Articles 83 to 86 require post-market surveillance, including periodic safety update reports for Class IIa, IIb and III devices. Regulation (EU) 2023/607, adopted on 15 March 2023 and entering into force on 20 March 2023, amended MDR Article 120. It extended transition periods for eligible legacy devices to 31 December 2027 or 31 December 2028, depending on classification and device type. These extensions are conditional, not automatic: requirements include continued directive compliance, no significant design or intended-purpose changes, no unacceptable health or safety risk, and specified deadlines for quality management systems, conformity assessment applications and notified body agreements.

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.

Grouped by theme

Editor's picks

· Hand-selected related concepts

Regulatory

EU In Vitro Diagnostic Regulation(IVDR)

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

Regulatory

CE Mark

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

Regulatory

EUDAMED

European Database on Medical Devices.

Regulatory

Notified Body(NB)

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

EU MDR Essentials

· From this learning path

Regulatory

Unique Device Identification(UDI)

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

Post-Market

Field Safety Corrective Action(FSCA)

Action taken to reduce a risk of serious deterioration in health associated with a device.

Post-Market

Medical Device Vigilance

Reporting and management of serious incidents and field safety corrective actions.

Post-Market

Periodic Safety Update Report(PSUR)

Periodic EU MDR/IVDR report summarizing post-market surveillance findings.

Cited by

Where this term appears across MedTech Terms.

Learning paths (1)

EU MDR EssentialsLesson 1 of 9

Ecosystems (2)

Comparisons (1)

EU MDR vs EU IVDRvs EU In Vitro Diagnostic Regulation

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Sources

3 sources

Sources support the definition or relevant regulatory context, not necessarily every claim on this page. Each is graded against our source-tier hierarchy so you can see what rests on binding law versus commentary.

Tier 1Binding law and standards· 2Tier 2Regulator guidance and consensus· 1

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

EUR-Lex·2European Commission·1

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On this term

Category: Regulatory
Acronym: MDR
Sources: 3
Use cases: 1
Updated: 9/19/2026

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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).
·The MDR replaced the Medical Devices Directive (93/42/EEC) and the Active Implantable Medical Devices Directive (90/385/EEC) and has applied since May 26, 2021.

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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