EU MDR Requirements
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All medical devices to be marketed and sold within the European Union must strictly adhere to European Union Medical Device Regulation (EU MDR) requirements. The approval process for meeting MDR requirements is extensive and involves various clinical evaluations of the product for health and safety–as well as efficacy–in a clinical setting.
Furthermore, Clinical Evaluation Reports for medical devices must be compiled from all relevant clinical evaluations and submitted to the Notified Bodies.. This article will help explain what EU MDR requirements are and how medical device manufacturers meet them to release their products into the European market.
What Is EU MDR and When Did It Take Effect?
To understand EU MDR, we must first understand its predecessor, the Medical Devices Directive (MDD). The MDD was a European Union law passed in June 1993 and implemented in 1994. It sought to harmonize the medical device regulations of various European countries under one single law that would be universally recognized. Although the MDD was a comprehensive piece of regulatory legislation for its time, it had begun to show its age after twenty-five years. In 2017, the MDD was repealed by the European Parliament and replaced with MDR to allow medical device manufacturers time to enact the new law on May 26th, 2021.
The MDR took what already existed under MDD and expanded it to include a host of additional language to cover all directives of the MDD. Where the MDD mentions the word ‘safety’ forty times, the MDR mentions it 290 times. In regards to a substantial focus on patient safety, the MDR is also four times longer and has five additional annexes.
New products being introduced into the European market must comply with MDR requirements. In addition, products previously approved by MDD regulations must be recertified under MDR if they are used to treat new conditions they were not originally designed to treat. Eventually, all medical devices are expected to comply with MDR. Additionally, the MDR added new requirements regarding additional devices not previously regulated including , but not limited to:
- Contact lenses such as cosmetic non-prescription colored contact lenses
- Cosmetic body implants designed to change a person’s appearance, such as surgically implanted horns
- Dermal filler injections
- Medical devices used to destroy fatty tissue, such as liposuction devices and body sculpting devices
- Laser emitting devices for the removal of things, such as body hair or tattoo removal
- Brain stimulation equipment, such as electronic cranial implants, for reduction of seizures or to assist the fully disabled in communicating properly
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What Is New for Safety Regulations?
Clinical evaluations were previously all that was needed to bring a product to market under MDD regulations. The MDR has enhanced its focus on safety, introducing several new regulations pertaining to not only the devices before they go on the market, but also new regulations that cover mandatory follow-up and reporting after they have been released onto the market. In this way, the MDR ensures that unforeseen issues that may arise after a product is used on the population are adequately reported, recognized, and addressed.
This new reporting system is outlined with additional requirements known as “Post-Market Clinical Follow-Up Evaluation Reports,” which will require medical device manufacturers to examine the efficacy and safety of their devices currently on the market annually. Further regulatory language augments the follow-up reports relating to Post-Market Surveillance (PMS), whereby manufacturers must report any abnormalities or post-market safety issues to the relevant Notifying Body. Learn more about Clinical investigations versus clinical evaluations.
One of the biggest steps in enhancing safety in labeling and device identification is the introduction of Unique Device Identification (UDI). This ensures that every MDR-approved device that goes to market will have a unique identifying serial number, as well as that all devices sold by the company can be tracked, and that if a batch of defective devices is released, they can easily be identified and returned to the manufacturer as part of a mandatory recall. This also improves patient safety by cracking down on black market and counterfeit devices, which may be sold by unlicensed or malicious medical device distributors.
In Summary
While it is impossible to summarize all 333 pages of the MDR legislation here in this article, you can see that the MDR goes to great lengths to update medical device regulations for the 21st century. By addressing several new devices, as well as updated safety and tracking of devices both pre and post-market, the MDR ensures that patient safety in terms of medical devices has never been more comprehensive.
Part of the process of regulatory approval for MDR is the understanding of what clinical evaluation reports are as well as examining them. This examination of reports is a time-consuming and arduous process, but fortunately, DistillerSR is an excellent tool for literature review and automates the process of examining databases filled with reports that could take months to sift through.
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