Take a closer look at the new Medical Device Regulation
The EU Medical Device Regulation (MDR) provides a framework for responsible innovation, ensuring patient safety and product quality, for manufacturers that aim to provide their Medical Devices for the European market.
The MDR builds on and replaces the Medical Device Directive (92/42/EEC) (MDD) that was in place before the introduction of EU MDR in 2017. The new EU MDR aligns closely with the United States regulations, the FDA’s 21 CFR on Food and Drugs Subchapter H, Medical Devices.
Even though the new regulation substantially changes the requirements for market entry and compliance in Europe, it also aims to support innovation by increasing transparency through data standardization, knowledge sharing, understanding the user journey and each company’s own data.
The list of new requirements from MDR is substantial. A few highlights are given below:
- Identification, labelling and traceability of all devices
- New registration and risk classification of devices
- Clinical evaluation to validate intended use
- Conformity assessments
- Clinical investigations
- Complete and comprehensive Quality Management System (QMS) must be in place to ensure quality throughout the product lifecycle, including post-market surveillance and vigilance.
Registration and risk classification of devices expands the product scope to include products that prior to MDR had been classified as cosmetic, such as contact lenses, cosmetic body implant devices and -materials. Any device designed for “prediction and prognosis” of a health condition will also be classified under the new Medical Device classification system that designates some of the cosmetic items in the high risk, Class III group. A device must be evaluated for the revised risk classifications to ensure that each company is providing sufficient documentation.
Device traceability is ensured by introduction of the Unique Device Identification (UDI) mechanism that requires each company to provide a method of tracking each individual device which in turn enables the company to efficiently recall medical devices in the event of a safety risk.
Regulations for the medical device and pharmaceutical industries are increasingly aligning and the medical device regulations are becoming more similar to the regulations in the area of clinical investigations. The onus is on each company to provide sufficient clinical evidence for patient benefits compared to the risk involved. As the risk and medical device classification increases from Class I through Class III so does the required evidence for patient benefit and safety. Central to MDR is the focus on the entire product lifecycle which includes post-market clinical data as well as to data gathered during Phase IV clinical trials.
Many established medical device manufacturers have already implemented a QMS based on requirements from ISO 13485:2016 and 21 CFR Part 820, and regular Notified Body audits support the continued improvement of these. MDR will now require all medical device companies to have a functioning QMS alongside at least one Qualified Person (QP) that is ultimately “responsible for regulatory compliance” within the company. The QP should have extensive knowledge of the quality processes within the company and have close collaboration with the Quality Assurance Department.
Turning compliance into a competitive advantage
The above mentioned changes are considerable; thus, challenging existing and new companies to (re-)evaluate their products for the European market. The new regulations opens up a possibility to drive innovation and benefits for the manufacturer if they identify the continued improvement potentials that arise from the added traceability, transparency, investigation and quality requirements.
Post-market surveillance can help a company to better understand their customers; their medical journey, issues, pain-points and use this information to feed their product development pipelines thereby driving the competitive advantage.
For medical devices using any sort of processing power the traceability of each device can provide insights into root causes for product issues, akin to a plane’s black box, especially if they result in recalls due to safety concerns. In that event, the unique identification can enable the company to limit patient risk and thereby conserving brand reputation and value.
Thorough clinical investigations and evaluations may provide further insight into the risk-benefit for end users and guide elimination of marginal or unnecessary products.
Active use of information from competing devices registered in the Eudamed database can also alleviate some of the challenges in adjusting to the new devices risk classifications and pre- and post-market clinical studies. It could reveal new supply chain opportunities, individual country market entry opportunities and distribution options.
Ultimately, the MDR benefits the patients using medical devices by ensuring quality products with a responsible safety profile. Manufacturers using the MDR framework for their own advantage can also benefit by being able to provide novel, innovative and improved medical devices.
Aske Rasmussen supports clients in the Medical Device industry with implementation of global, harmonized quality processes and IT systems. He specializes in analyzing and optimizing processes, validation, developing quality documentation (GxP and GMP), implementing process improvements, IT and working in a GMP environment. Aske has a strong academic background within Nanotechnology and holds a Master of Science in Nanobiotechnology.