The new EU MDR is not entirely different from the current MDD (Medical Device Directive). The only important thing is that manufacturers of medical devices and suppliers will require additional work to comply with the new EU MDR guidelines.
As the organizations plan to execute their new projects to bring the organization to meet the new EU MDR guidelines, they need to be aware of all the significant changes that will require action and plan.
The new regulations increase medical device safety and success in the EU market. In addition, the new EU MDR is also responsible for shaping the medical device industry regarding technical and scientific developments.
This article summarizes the quick changes in the new EU guidelines assisting medical organizations in implementing transitions to the new regulations.
Fundamental changes in the EU MDR
- The new MDR doc is four times longer and contains five more annexes than MDD.
- In the new regulation, the word safety appears 290 times in the MDR.
- According to new guidelines, the Unique Device Identification (UDI) will help track the devices.
- Under MDR, medical purpose devices and AIMD are both included. These were not encompassed under MDD guidelines.
- According to the new EU Medical Device Regulation, manufacturers need to create clinical data more in-depth now.
- Will also broaden The definition of medical devices to include non-medical and cosmetic devices, which was not earlier in the regulation.
- Remarkable changes in the working of the new law will require organizations to justify portfolios and perform a global impact assessment to implement changes according to the new MDR.
- In Annex 1, general safety and performance requirements identify new conditions that must address for most legacy devices, and existing products must be certified.
- In the future, manufacturers have to report all incidents; injuries and death cases into an EU portal so that patients have access to more safety-relevant data.
- Companies undergoing transitions will require careful review, planning, and reimplement in compliance with new requirements.
- Under technical documentation, the new requirements are more apparent than before, so the technical documentation may be longer this time.
- During registration, more information may require about the device, and importers will also be required to register this time.
- The new EU MDR introduces a requirement to produce a PMS report depending on the device class and a periodic safety update report.
Application of the New EU MDR
The date of application of the new EU MDR has set to May 2021. 1 year back, to relieve pressure on medical companies, manufacturers; national authorities, and other stakeholders just because of the covid-19 crisis.
Notified bodies are under pressure to implement new regulations on pre-existing products before the MDR arrives in May 2021. Therefore, all manufacturers extending their MDD certificates before May 2021 should develop to the possible extent.
Conclusion
Despite all the uncertainty with harmonized standards and how MDR will implement by regulators and notified bodies; manufacturers ought to thoroughly understand the new regulations to prepare for future changes.
FAQ
What are the new MDR requirements in the EU?
Must now label all medical equipment markets in the European Union (EU) with a unique device identifier (UDI). Will assign a manufacturing identification and a device identifier (DI) to each batch or series of the product (PI).