The new EU MDR is not completely different from the current MDD (Medical Device Directive). The only important thing is that manufacturers of medical devices and suppliers of these devices 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 major changes that will require action and plan.
The new regulations pursue to increase medical device safety and success in the EU market. The new EU MDR is also responsible to shape the medical device industry in terms of technical and scientific developments.
This article aims to show the summary of the quick changes in the new EU guidelines assisting medical organizations to implement transitions to the new regulations.
Key changes in the EU MDR
- The new MDR doc is 4 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 be implemented to help track the devices.
- Under MDR medical purpose devices and AIMD, both are 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.
- The definition of medical devices will be broadened to include non-medical and cosmetic devices also 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 will need to be addressed for most legacy devices, and existing products must be certified.
- Going forward 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 clear 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 new requirement to produce a PMS report depending on the device class and a periodic safety update report.
The date of application of the new EU MDR has been 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 crises.
Notified bodies are under pressure to implement new regulations on pre-existing products before the MDR arrives in May 2021. Temporary all manufacturers are depending on extending their MDD certificates before May 2021 should develop and to the possible extent.
Despite all the uncertainty with harmonized standards and how MDR will be implemented by regulators and notified bodies manufacturers ought to completely understand the new regulations to prepare for future changes.
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Peter Dong is a writer and a professional EU MDR consultant.