Overview
The European Union's regulatory framework for medical devices has undergone its most significant transformation in over two decades. The Medical Device Regulation (MDR 2017/745) and the In Vitro Diagnostic Regulation (IVDR 2017/746) now govern how medical devices and diagnostics are developed, manufactured, placed on the market, and monitored throughout their lifecycle.
For those of us working in medical device management within EU healthcare settings, understanding these regulations is fundamental to our daily practice. Whether you are responsible for procurement, clinical engineering, laboratory services, or general equipment management, the MDR and IVDR affect virtually every aspect of how we work with medical technology.
This section provides a comprehensive introduction to both regulations, explaining their background, objectives, scope, and practical implications for healthcare institutions.
Background and Context
The Need for Regulatory Reform
The previous regulatory framework—comprising the Medical Devices Directive (93/42/EEC), the Active Implantable Medical Devices Directive (90/385/EEC), and the In Vitro Diagnostic Devices Directive (98/79/EC)—served the EU well for many years. These directives created a harmonised single market for medical devices across member states.
However, the medical device landscape has changed dramatically since the 1990s. Technological advancement has accelerated, bringing sophisticated software applications, combination products, personalised medicine, and increasingly complex diagnostic systems. The old directives had not kept pace with these developments.
Perhaps more significantly, several high-profile device failures exposed serious weaknesses in the existing system. The most notable was the Poly Implant Prothèse (PIP) breast implant scandal, where industrial-grade silicone was used instead of medical-grade material, affecting hundreds of thousands of patients across Europe. The metal-on-metal hip implant controversy and concerns about certain IVDs further highlighted the need for reform.
These incidents demonstrated that the existing framework lacked sufficient transparency, traceability, and clinical evidence requirements. The new regulations were developed to address these gaps comprehensively.
Key Objectives of MDR and IVDR
Both regulations share common objectives aimed at ensuring a high level of health and safety protection whilst maintaining a functioning internal market for medical devices.
Enhanced Safety and Quality
Strengthening clinical evidence requirements and ensuring devices are safe and perform as intended throughout their entire lifecycle.
Improved Transparency
Creating the European Database on Medical Devices (EUDAMED) to provide public and professional access to device information.
Better Traceability
Implementing a Unique Device Identification (UDI) system to track devices throughout the supply chain and facilitate recalls.
Strengthened Oversight
Enhancing the designation, supervision, and monitoring of Notified Bodies responsible for conformity assessment.
Scope of the Regulations
What the MDR Covers
The MDR applies to medical devices and their accessories. Importantly, its scope has been broadened to include:
- Certain aesthetic devices with no intended medical purpose but similar risk profiles (e.g., decorative contact lenses, dermal fillers, liposuction equipment)
- Software as a Medical Device (SaMD), which is now explicitly included and subject to risk-based classification
- Devices for cleaning, disinfection, or sterilisation of other medical devices
- Devices incorporating nanomaterials
- Devices manufactured using tissues or cells of human origin that have been rendered non-viable
What the IVDR Covers
The IVDR applies to in vitro diagnostic medical devices (IVDs)—products intended for the examination of specimens derived from the human body. This includes:
- Reagents, calibrators, control materials, and specimen receptacles
- Instruments and software used to examine specimens
- Companion diagnostics linked to specific medicines
- Laboratory-developed tests (under certain conditions)
Implementation Timeline
Both regulations were published in May 2017, but their implementation has been staggered to allow the industry to adapt. Extended transition periods have been granted for devices certified under the old directives.
| Regulation | Date of Application | Higher Risk Transition | Lower Risk Transition |
|---|---|---|---|
| MDR 2017/745 | 26 May 2021 | 31 Dec 2027 (Class III, IIb implantables) | 31 Dec 2028 (Other Class IIb, IIa, I) |
| IVDR 2017/746 | 26 May 2022 | 31 Dec 2027 (Class D) | 31 Dec 2029 (Class B, A sterile) |
Important: These transition periods are conditional. Manufacturers must have a quality management system in place and lodge an application with a Notified Body by specific deadlines to benefit from extended timelines.
Practical Implications for Acute Hospitals
The MDR and IVDR have direct, practical implications for those of us working in hospital settings. Here are the key areas of impact:
In-House Manufacturing
Many hospitals develop devices "in-house" for specific patient needs. Under the MDR, this practice is now subject to specific requirements. While a "health institution exemption" exists, it requires:
- Justification that no equivalent commercial device is available on the market
- An appropriate Quality Management System (QMS)
- The device must be manufactured and used only within the health institution
- Appropriate documentation and safety reporting
Procurement and Compliance Verification
Procurement departments must now verify that all newly purchased devices are MDR-compliant. This means:
- Checking for valid CE marking under the MDR (not the old directive)
- Verifying the Notified Body number where applicable
- Ensuring suppliers can provide UDI information
- Understanding transition periods for legacy devices
UDI Implementation and Traceability
The Unique Device Identification system will transform how we track devices. Staff will need to engage with UDI scanning for:
- Recording implantable devices used in procedures
- Tracking devices through internal supply chains
- Facilitating rapid response to safety notices and recalls
- Supporting post-market surveillance activities
Vigilance and Incident Reporting
There are enhanced obligations for reporting incidents or near-incidents involving medical devices. Healthcare institutions should review their internal reporting procedures to ensure they can meet these requirements efficiently.
Case Study: Hospital In-House 3D Printing
Scenario
A regional hospital's clinical engineering department has been using 3D printing technology to create patient-specific surgical guides for orthopaedic procedures. Prior to the MDR, this activity operated in a regulatory grey area.
MDR Implications
Under MDR Article 5(5), health institutions that manufacture and use devices internally must now:
- Document why no suitable commercial alternative exists
- Implement a QMS appropriate to the class of devices produced
- Conduct clinical evaluation and risk management
- Report adverse incidents to the Competent Authority
- Make information available to the Competent Authority upon request
Practical Response
The hospital established a formal governance structure for in-house manufacturing, appointed a responsible person with appropriate qualifications, documented their processes, and implemented a quality management system aligned with ISO 13485 principles. They also established a systematic approach to clinical evaluation and post-production monitoring.
Practical Implications for Community Healthcare
Community healthcare settings face their own specific challenges under the new regulations, particularly regarding in-vitro diagnostics.
Impact on Laboratory-Developed Tests
The IVDR significantly impacts laboratories that develop and use their own "in-house" or laboratory-developed tests (LDTs). Under the new rules:
- Most LDTs must be CE-marked unless a strict exemption applies
- To claim exemption, labs must prove no commercial alternative exists
- Laboratories must comply with ISO 15189 or equivalent standards
- Extensive validation data must be generated and maintained
Point-of-Care Testing
Community healthcare facilities using point-of-care testing equipment need to ensure their devices are IVDR-compliant and that staff understand any changes to device operation, quality control requirements, or reporting obligations.
Supply Considerations
The stricter IVDR requirements may lead to some diagnostic tests being discontinued by manufacturers. Community healthcare providers should monitor their diagnostic supply chains and plan for potential product discontinuations.
Case Study: Community Laboratory LDT Transition
Scenario
A regional clinical laboratory provides specialised genetic testing services for rare inherited conditions. They have developed several laboratory-developed tests over the years because no commercial alternatives existed.
IVDR Implications
Under the IVDR, these tests now require either:
- Full CE marking as an IVD (which would require significant investment and likely involvement of a Notified Body), or
- Documentation that the health institution exemption applies, with appropriate QMS and validation
Practical Response
The laboratory conducted a comprehensive review of each test, determining which could transition to commercial alternatives and which genuinely required the exemption. For exempt tests, they strengthened their quality management system, generated comprehensive analytical and clinical performance data, and established robust documentation practices. They also engaged with their Competent Authority to ensure their approach met regulatory expectations.
The European Database on Medical Devices (EUDAMED)
EUDAMED is a key transparency measure under the new regulations. When fully operational, it will provide:
- UDI Database: Registration of all devices with their unique identifiers
- Economic Operator Registration: Information on manufacturers, authorised representatives, and importers
- Notified Body Information: Details of designations and certificates issued
- Clinical Investigations: Information on clinical studies being conducted
- Vigilance Reporting: Safety-related data (with restricted access for some elements)
- Market Surveillance: Information on regulatory actions
For healthcare professionals, EUDAMED will eventually become a valuable resource for verifying device compliance, checking for safety notices, and understanding the devices used in clinical practice.
Key Takeaways
- 1. Comprehensive Reform: The MDR and IVDR represent the most significant changes to EU medical device regulation in over 20 years, driven by safety concerns and technological advancement.
- 2. Broader Scope: Both regulations have expanded scope, bringing more products under regulatory control and often into higher risk classifications.
- 3. Lifecycle Approach: The focus has shifted from pre-market approval to continuous monitoring throughout a device's lifecycle.
- 4. Healthcare Institution Obligations: Hospitals and community healthcare facilities have new responsibilities, particularly regarding in-house manufacturing and laboratory-developed tests.
- 5. Transition Periods: Extended deadlines exist for legacy devices, but these are conditional and require proactive engagement with the new requirements.
- 6. Enhanced Transparency: EUDAMED and UDI will transform how device information is accessed and tracked.
Next Section
Key Changes from MDD to MDR (Coming Soon)