The Medicines & Healthcare products Regulatory Agency (MHRA), the UK authority responsible for medical device regulation, published guidance dedicated to medical devices without an intended purpose and the way they should be regulated under the Regulation 2017/745 (MDR).
Products Without An Intended Medical Purpose: Definition And Features
The Medical Device Regulation 2017/745 contains the Annex XVI describing products that could be subject to regulation as medical devices under the MDR framework. According to general rules set forth by the MDR, this category includes products with features and characteristics related to the risk associated with their use, similar to ones for medical devices that are intended by the manufacturer for other non-medical purposes. These products were out of the regulatory scope prior to the adoption of the MDR. The main goal of their addition to the list of regulated devices is to ensure the safety and protection of a customer’s health.
All products without an intended medical purpose could be divided into the following groups:
- Contact lenses or similar products, e.g. non-prescription ones.
- Implants and other products that could be introduced into the human body to change the anatomy. As usual, such products should be introduced using invasive methods.
- Product used for dermal filling, such as substances or their combinations, introduced through injections.
- Devices used for the reduction of adipose tissue, e.g. body sculpting equipment.
- Devices used for skin resurfacing (e.g. removing hair or tattoo), such as hair removal devices based on high-intensity electromagnetic radiation.
- Devices used to impact brain activity through the stimulation with the help of magnetic or electromagnetic fields, such as devices for non-invasive stimulation.
The appropriate list of groups of products is provided in Annex XVI to the MDR. According to the Regulation, the European Commission must review and make amendments to the aforementioned list by supplementing it with the new groups if found reasonably necessary to protect public health and ensure the safety of any person using such products.
Obligations Of The Manufacturers
Since the aforementioned devices are subject to regulation under the MDR, their manufacturers would have to comply with all applicable requirements set forth by the regulation. These requirements are similar to ones applied for medical devices and mostly related to safety matters.
To maintain compliance, the manufacturers shall:
- Define the class in accordance with the risk-based classification
- Assess compliance with the requirements set forth by the Regulation 2017/745,
- Appeal to the MDR-designated Notified Body to perform the conformity assessment
- Submit the declaration of conformity (DoC) which requires the placement of a CE mark on the product confirming compliance with safety requirements. Any and all devices intended to be placed on the EU market should bear the CE mark
- Register the device in the database and assign the unique device identifier (UDI) used to track the device and make medical device circulation much more transparent
- Provide the details on the manufacturer of the device and authorized representative appointed by the manufacturer to be responsible for all communications regarding the device within the particular region to the authority entitled to upload information to the Eudamed. Eudamed is the EU database containing information about medical devices, their manufacturers, the certificates issued or amended by the notified bodies, and also about all adverse events that took place when using the devices and the results of investigations conducted regarding such incidents.
- Make the device available on the market
- Comply with all applicable requirements relating to the post-marketing surveillance, e.g. to perform field safety corrective actions (FSCA) – special measures taken by the manufacturer to avoid or reduce the harm that is caused or could be caused to users by the device. In the course of FSCA, the manufacturer could provide additional warnings and recommendations for safe use of the device, make changes necessary to fix the shortcomings of the device causing hazard, or even to withdraw some of the devices (for example, the particular consignment) or whole devices of the particular model from the market. Post-marketing surveillance requirements also include the obligations to notify the regulating (supervising) authority on any and all adverse events and incidents that took place when using the devices by users or healthcare facilities. All such incidents should be rigorously investigated by the manufacturer, and the final report should be also submitted to the authority.
Additional Requirements For Products Other Than Medical Devices
Safety and performance requirements for products without an intended medical purpose and ways to confirm compliance with these requirements are provided in common specifications. These specifications describe the applicable requirements on product assessment, clinical evaluation and risk management principles. In particular, the requirement for the manufacturers to comply with the applicable common specifications is set forth in Article 9 of the MDR. It is also important to mention that these specifications have not already been adopted. According to the guidance, they are expected to be adopted by May 26, 2020, when the Regulation should be implemented. According to the MDR, prior to that time, products without an intended medical purpose falling within the scope of the Directive 93/94/EEC should follow the appropriate requirements until the new common specifications dedicated to such products would be adopted.
Besides the requirements set forth in the appropriate common specifications, the manufacturers of the products covered by the guidance should confirm compliance with other additional requirements, namely,
- Class of the device should be properly identified by the manufacturer in accordance with the risk associated with the use of the device,
- It is necessary to appoint the person responsible for regulatory compliance,
- All parties involved in operations with the medical device within its supply chain should comply with applicable regulations,
- The manufacturer should have a financial coverage that is sufficient considering the potential liability,
- The manufacturer should also fulfill the reporting requirements in accordance with the vigilance reporting timescale and to submit the annual safety reports.
Under the MDR, to fulfill the requirement for clinical benefit demonstration, the manufacturer should demonstrate the performance of the device. It is also provided that it is allowed to use clinical data collected when using a medical device having similar features as a basis for clinical investigation.
Thus, the Regulation 2017/745 provides detailed requirements the manufacturers should comply with even if the devices they produce are not medical devices according to the intended purpose.
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