EU MDR vs IVDR: Key Differences and Compliance Timelines
Summary:
- The MDR covers Medical Devices and certain products without an intended medical purpose, while the IVDR covers In Vitro diagnostic Medical Devices and their accessories.
- The MDR classifies devices as Class I, IIa, IIb and III, while the IVDR uses Classes A, B, C and D based on the device type and risk.
- The MDR mainly uses clinical evaluation and the IVDR uses performance evaluation, while both regulations have different conformity assessment requirements based on device classification.
- Manufacturers must follow the applicable transition deadlines, including the extended IVDR deadlines, and continue meeting requirements for documentation, quality management, surveillance, vigilance and regulatory compliance.
The European Union Medical Device Regulation and In Vitro Diagnostic Medical Device Regulation set different requirements for Medical Devices and diagnostic devices, covering their scope, classification, evidence, conformity assessment, transition periods and ongoing EU MDR compliance responsibilities.
Overview of the EU MDR and IVDR
The Medical Device Regulation (MDR) is the European Union law that sets rules for Medical Devices and their accessories. It also covers clinical investigations and certain products used for medical purposes.1
The In Vitro Diagnostic Medical Device Regulation (IVDR) sets rules for in vitro diagnostic Medical Devices and their accessories. It also includes IVDR requirements for performance studies carried out to assess these devices.2
Regulatory Scope and Applicability
The MDR and IVDR apply to different types of products, but their scope also includes specific exclusions and situations where more than one regulatory requirement may need to be considered.
These are the key scope considerations:
- Multiple intended purposes: Products with both medical and non-medical purposes must meet the relevant requirements for both.
- MDR exclusions: The MDR does not cover medicinal products, cosmetics, food, human blood and plasma, or certain human and animal tissues and cells.1
- IVDR exclusions: The IVDR does not cover general laboratory or research-use-only products unless intended for in vitro diagnostic use. Certain sampling products, reference materials and external quality assessment materials are also excluded.2
- Both regulations: If a product contains a component covered by the other regulation, the relevant requirements apply to that component.1,2
Key Differences Between MDR and IVDR
Although MDR and IVDR follow a similar regulatory structure, they differ in the type of devices covered, classification systems, evidence requirements and conformity assessment procedures.
| Aspect | MDR | IVDR |
| Scope | Covers Medical Devices and certain products without an intended medical purpose. | Covers in vitro diagnostic Medical Devices and their accessories. |
| Classification | Devices are classified into Class I, IIa, IIb and III according to intended purpose and inherent risk. | Devices are classified into Class A, B, C and D according to intended purpose and inherent risk. |
| Clinical or performance evidence | Requires clinical evaluation based on clinical data and sufficient clinical evidence to demonstrate safety and performance. | Requires performance evaluation based on scientific validity, analytical performance and clinical performance data. |
| Conformity assessment | The procedure depends on the device class. Class III and most Class II devices require notified body involvement, while certain Class I devices can be self-declared. | The procedure depends on the device class. Devices in Classes B, C and D generally require notified body involvement, while Class A devices can generally be self-declared unless supplied sterile. |
| Special assessment requirements | Certain high-risk devices, including Class III devices and specified Class IIb devices, have additional clinical and conformity assessment requirements. | Certain higher-risk devices, particularly Class D devices, may require additional laboratory verification and consultation with relevant authorities or expert panels. |
| Post-market evidence | Clinical evaluation is updated throughout the device life cycle using clinical data, including data from post-market clinical follow-up and post-market surveillance.1 | Performance evaluation is continuously updated using performance data, including post-market performance follow-up and post-market surveillance data.2 |
Table 1
Transitional Provisions and Compliance Timelines
Both MDR and IVDR introduced transition periods to support the movement from the previous Directives to the new regulatory frameworks.
The main dates and transition deadlines are:
- MDR transition: Certificates issued before 25 May 2017 generally remained valid until expiry, while some became void by 27 May 2022. Certificates issued from 25 May 2017 became void by 27 May 2024.1
- Extended MDR transition: Eligible devices could continue under the earlier Directives if there were no significant design or intended-purpose changes. MDR requirements for surveillance, vigilance and registration also applied.1
- IVDR transition: Certain certificates under Directive 98/79/EC remained valid until expiry, while specified certificates became void by 27 May 2024. Eligible devices placed on the market before 26 May 2022 could remain available until 27 May 2025.
- Extended IVDR transition: Eligible legacy devices requiring notified body involvement can transition until 31 December 2027 (Class D), 31 December 2028 (Class C) and 31 December 2029 (Class B and A sterile), subject to conditions including no significant changes, no unacceptable risk and an IVDR-compliant quality management system.2,3
These transition periods give manufacturers time to meet the requirements of the MDR and IVDR while maintaining access to the European Union market.
Conclusion
- The Medical Device regulation EU 2017/745 provides the main regulatory framework for Medical Devices in the European Union, with the MDR and IVDR having different scopes, classifications and evidence requirements.
- Following the correct conformity assessment and transition requirements is important to maintain compliance and support the safe use of Medical Devices and in vitro diagnostic Medical Devices.
- CliniExperts can support manufacturers with MDR and IVDR regulatory requirements, helping them plan the right regulatory pathway and maintain compliance throughout the device life cycle.4
References
1. Regulation – 2017/745 – EN – Medical Device Regulation – EUR-Lex. Accessed September 5, 2026. https://eur-lex.europa.eu/eli/reg/2017/745/oj
2. Regulation – 2017/746 – EN – IVD – EUR-Lex. Accessed September 5, 2026. https://eur-lex.europa.eu/eli/reg/2017/746/oj
3. Transitional provisions – Public Health – European Commission. April 15, 2026. Accessed September 5, 2026. https://health.ec.europa.eu/medical-devices-vitro-diagnostics/transitional-provisions_en
4. Regulatory Affairs Consulting EU UK USA| UK MHRA Medical Device Approval| Medical Device Regulatory Consulting Services in EU, UK, USA| EU Regulatory Compliance for Medical Devices. Accessed September 5, 2026. https://international.cliniexperts.com/
Recent Posts
QSR Compliance for Medical Device Manufacturers: FDA Quality System Regulation Explained
QSR compliance FDA helps Medical Device manufacturers meet FDA quality requirements under the Quality Management System Regulation and 21 CFR Part 820. The requirements include ISO 13485:2016, manufac..
eCTD Publishing for FDA Drug Submissions: What Sponsors Need to Know
eCTD Publishing FDA helps sponsors organise regulatory information, prepare FDA submissions, follow submission standards, check electronic files for errors, and send complete submission packages throu..
Contact us
Please feel free to talk to us if you have any questions. We endeavour to answer within 24 hours.