Understanding the transition periods
The Medical Device Regulation (MDR) replaced the EU’s original MedicalDevices Directive (MDD). The MDR was implemented in May 2017 and became applicable in May 2021. This means that all newly developed and certified medical devices must fulfil the MDR requirements. Medical devices which are already on the EU market before may 2021 and registered under the MDD (which are called as legacy devices) are allowed to have a transition period to comply with the MDR. Transition period is defined according to classification of the device, which are;
· May 2026 - for class III custom-made implantable devices
· December 2027 - for higher-risk products (class III devices and class IIb implantable devices, except sutures, staples, dental fillings, dental braces, tooth crowns, screws, wedges, plates, wires, pins, clips, and connectors)
· December 2028 - for medium and lower risk products (other class IIb devices, class IIa devices, and class ls, lm, lr)
To get benefit from this transition period, all manufacturers with MDD CE certificate must establish a quality management system aligned with the new MDR by May 2024, and should have a written agreement with a Notified body bySeptember 2024. After that manufacturer should have a Confirmation Letter which is issued by notified body.(*)
Key differences between de MDR and the MDD
The EU-MDR introduces stricter rules than the MDD, to make sure medical devices are safer and work better. Some major changes are:
- More devices are included: The MDR now covers some devices that don’t have a medical purpose, like cosmetic implants.
- Stronger safety checks: Manufacturers must provide more proof that their devices are safe and work as intended. This means that there are stricter rules on clinical evaluation.
- Clinical evidence: Demands more robust clinical evidence, especially for high-riskdevices, and limits reliance on equivalence unless clear justification is provided.
- Device tracking: Each device now has a unique code (UDI) that makes it easier totrack, helping with recalls or safety updates.
- Ongoing Monitoring: Manufacturers must keep checking how their devices perform after they’re on the market and report any issues. This means that manufactures need to report data throughout the device lifecycle.
- Technical documentation: Requires comprehensive technical documentation with expanded content, including detailed clinical evaluation, risk management, and lifecycle updates.
The MDR changes mean higher safety standards, more focus on keeping patients safe, continues improvement and traceability compared to the MDD.
Take away for hospitals and medical practices
The transition to the MDR offers benefits for hospitals and medical practices, including:
· Enhanced Device Safety: Stricter testing and monitoring rules mean that devices are more reliable, effective andsafe to use.
· Better Traceability: The implementation of UDI ensures faster response times in the event of recalls orsafety concerns.
· Improved Patient Outcomes: Higher standards for devices lead to better results for patients and fewer risks.
· Operational Efficiency: Clearer rules and safer devices make it easier for hospitals to make good buying decisions and avoid problems.
Staying informed about these changes helps healthcare facilities to make better procurement decisions and maintain their focus on delivering exceptional care.
(*) Q&A on practical aspects related to the implementation of Regulation (EU) 2023/607 - Extension of the MDR transitional period and removal of the “sell off” periods
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