The new Medical Devices Regulation (MDR) represents a long-awaited strengthening of the existing European regulatory system for medical devices. It replaces previous EU regulations on medical devices and implantable medical devices that had been in place since the early 1990s. The new MDR regulation now applies to all medical device manufacturers, importers and distributors.
When does the new Medical Device Regulation take effect?
The EU MDR entered into full application on 26 May 2021. The new legislation is intended to improve the safety of medical devices within the European Union, as it brings forward a set of new standards and requirements which medical products must comply with.
Over the coming years, compliance with this new Medical Devices Regulation represents a real challenge for the MedTech industry. Asphalion’s team of compliance experts is ready to assist companies throughout the whole MDR compliance transition process.
☑️ You can find all services ASPHALION can offer regarding MDR here: https://www.asphalion.com/services/medical-devices/
What are the key changes in the new Medical Devices Regulation?
The MDR is one of the most significant updates to the regulations on medical devices in Europe. It will involve widespread changes in how devices are being manufactured and the level of compliance and clinical data required to bring them to the European market.
Summary of the key changes:
1- New classification rules
2- Enlarged list of General Safety and Performance Requirements (GSPRs)
3- Specific classification rules and GSPRs for particular products and technologies (SaMD, nanotechnologies, substance-based devices, etc.)
4- Enhanced emphasis on risk management and clinical evidence
5- Common specifications for particular products and technologies
6- New players (expert panels) and increased scrutiny in conformity assessment procedures for high-risk devices
7- Emphasis on transparency (EUDAMED) and traceability (Unique Device Identification or UDI)
8- Proactive Post-Market Surveillance and Vigilance processes to be defined and implemented
9- New mandatory roles (Person Responsible for Regulatory Compliance or PRRC)
10- Specific requirements for integral drug device combinations (article 117)
ⓘ For more information about the application of the new EU MDR, please follow this link:
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