The medical device industry is undergoing significant regulatory changes with the transition from the Medical Device Directive (MDD) to the Medical Device Regulation (MDR). These new regulations aim to enhance the safety, performance, and traceability of medical devices within the European Union. In this blog post, we will compare MDD and MDR, highlight the key differences, and provide an overview of the timelines for the transition for different classification products.
Key Differences Between MDD and MDR
- Scope and Classification:
- MDD: The MDD provided broad definitions and classifications for medical devices. However, some products, such as certain aesthetic devices, were not covered (SustainProgress).
- MDR: The MDR expands the scope to include a wider range of products, including those without a medical purpose, such as coloured contact lenses and cosmetic implants. The classification rules have also been revised, resulting in more devices being classified into higher risk categories (SustainProgress) (PharmaLex).
- Safety and Performance Requirements:
- MDD: Safety and performance requirements were less detailed, focusing primarily on essential requirements (SustainProgress).
- MDR: The MDR introduces more stringent General Safety and Performance Requirements (GSPR) that cover a broader range of considerations, including benefits and risks, clinical evaluation, and post-market surveillance (PharmaLex).
- Clinical Evidence:
- MDD: Clinical evidence requirements were less stringent and varied depending on the device classification (SustainProgress).
- MDR: The MDR significantly increases the requirements for clinical evidence across all device classifications. Manufacturers must provide robust clinical data demonstrating the safety and performance of their devices (SustainProgress) (PharmaLex).
- Post-Market Surveillance and Vigilance:
- MDD: Post-market surveillance and vigilance activities were not as rigorously enforced (SustainProgress).
- MDR: The MDR mandates comprehensive post-market surveillance and vigilance systems, including periodic safety update reports (PSUR) and trend reporting. Manufacturers must actively monitor their devices’ performance and report any incidents (SustainProgress) (PharmaLex).
- Unique Device Identification (UDI):
- MDD: There was no requirement for a unique device identification system (SustainProgress).
- MDR: The MDR introduces the UDI system to enhance traceability and improve post-market safety. Each device must have a unique identifier that can be tracked through the supply chain (SustainProgress) (PharmaLex).
The MDR introduces more stringent requirements aimed at improving device safety, performance, and traceability.
Timelines for Transition
The transition from MDD to MDR is a phased process with specific timelines for different classification products. Here is an overview of the key dates:
- Date of Application:
- The MDR officially entered into force on 25 May 2017, with a transition period that allowed manufacturers to comply with the new requirements (PharmaLex).
- Transition Period:
- The transition period initially ended on 26 May 2020. However, due to the COVID-19 pandemic, the European Commission extended the deadline by one year to 26 May 2021 (PharmaLex).
- Legacy Devices:
- Devices certified under MDD can continue to be placed on the market until 26 May 2024, provided there are no significant changes in their design or intended purpose.
- Following recent extensions, high-risk devices (Class III and certain Class IIb implantable devices) have until 31 December 2027 to transition. Lower-risk devices (Class I, IIa, and the remaining IIb devices) can transition until 31 December 2028, under specific conditions (Public Health) (Intertek) (PharmaLex)
The transition from MDD to MDR represents a significant shift in the regulatory landscape for medical devices in the European Union. The MDR introduces more stringent requirements aimed at improving device safety, performance, and traceability. MedTech companies must understand these differences and adhere to the new timelines to ensure compliance. By staying informed and proactive, manufacturers can navigate this transition smoothly and continue to provide safe and effective medical devices to the market.
At SwiftGxP, we connect MedTech companies with experienced consultants who can help navigate the complexities of MDR compliance. Whether you need assistance with clinical evaluation, post-market surveillance, or regulatory strategy, our network of experts is here to support you.
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