What Is Medical Device Regulation And How It Changed Over The Years

June 14, 2021

  

The field of medical device regulation has been significantly changing over the years. The implementation of the Medical Device Regulation in the EU in May 2021 is one significant change that was designed to introduce new changes in 2021. The new directive offers several changes that you should know. Read on to learn what Medical Device Regulation is and how it changed over the years.

What are the Key Changes?

The Medical Device Regulation that came into effect in May 2021 is a replacement of the Medical Devices Directive (93/42/EEC). Under this new mandate, the definition of a medical device has been broadened to include software and a change to the medical purposes that now encompass prediction. In short, the new changes mean that all the devices that were excluded by the Directive are now classified under the regulation.

New Definition of Regulated Devices

The new definition of regulation is now four times longer than the predecessor and there have also been some changes introduced in the wording. Companies will now be compelled to conduct global impact assessments and rationalize their portfolios so that they can be able to remain compliant. The definition of medical devices will be broadened under the new regulations to include cosmetic and non-medical devices that were not regulated previously. These will include gadgets like liposuction equipment, contact lenses, and epilation lasers. Active implantable devices (AIMD) and other medical purpose devices are now part of the MDR.

CE Marking and UDI

All the medical devices in the EU market should have a CE mark under the new regulations to ensure conformity assessment and compliance requirements stated by the Regulation. However, the Regulation provides more stringent measures, meaning that more devices would be reclassified as higher risk. This would require the manufacturer to take additional obligations to ensure that they comply with the new ordinance. For instance, the manufacturer would need to obtain a Clinical Evaluation Report (CER) to get initial CE marking. You can visit this website to gain insight into the changes that have taken place in medical regulation over the years. A literature review is critical for the success of your CER to demonstrate compliance and safety of your device.

Unique Device Identification (UDI) is another new change brought by the Regulation, and it aims to offer traceability of medical devices. For instance, the UDI links medical devices to the UDI database and will include a range of data about the manufacturer and the device. The Regulation also provides a centralized EU database that is used for the storage of information on all medical devices. The information about all devices will be gathered from the commission, economic operators, healthcare professionals, and member states.

Risk Management and Safety Measures

Another critical change brought by Medical Device Regulation relates to increased risk management and safety measures. The manufacturers should offer in-depth clinical data that proves high-performance standards and heightened safety measurements. The manufacturers are also obliged to report any incidents and deaths to the EU portal that has information that can be accessed by the patients. Additionally, the deadline for reporting various incidents that do not cause death has been reduced to 15 days from 30 days.

All transitioning companies are now compelled to revisit their core processes like risk management, quality assurance, and post-market expectations. Several medical devices will then be reclassified as a higher risk under the new regulations. There has also been a reclassification of reusable surgical devices.

Economic Operators

There are several economic operators involved in the medical industry and they are compelled to comply with the directives. The new Regulation affects almost all economic operators as they specifically focus on the device lifecycle instead of the steps involved in taking the medical device onto the market. All organizations that were previously excluded by the rulings now have to comply with the Regulation. Some of these economic actors include distributors, and they are supposed to comply with the new orders. The notified bodies should also take necessary measures to apply for the new designation. This could mean that the notified bodies can have long waiting times to get conformity assessments.

In May 2017, the EU introduced Medical Device Regulation changes that compel all manufacturers of these devices to meet new regulations. The new changes were supposed to come into effect in May 2021, and they are set to revolutionize the entire Medical Device Regulation to ensure compliance. The new regulations are stringent, and all manufacturers should prioritize high safety measures and risk management. All devices should have CE, and UDI marks under the new mandate. The new regulations compel all actors involved in the manufacturing of medical devices to ensure compliance and follow safety standards.

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