New Medical Device Regulation: Implications for Medical Device Manufacturers

1.0 Background

The implementation of the new medical device regulations (MDR) on 25^th May, 2017 has presented medical device manufacturers with several drastic changes in the decades old regulatory framework of the European Union (EU). The new MDR has effectively replaced the previous medical device directive (93/42/EEC) of the EU and also the directives relating to active implantable medical devices (90/385/EEC).

The new MDR offered medical device manufacturers with already approved devices in the market with a compliance time of three years till 26^th May, 2020, which is just around the corner. For certain medical device manufacturers, the new MDR offered extra time following the date of application which enables them to provide new products to the medical device market for a maximum extended time of four years. However, in this case, extra requirements would be applicable for this additional period of transition. 

2.0 Objective of the New MDR

The new MDR has been passed with certain specific objectives in mind. The key objective here is to make a two dimensional impact in enhancing the safety of medical devices(Laege Middle Styrelsen, 2019), which are;

• Reinforcing the rules associated with placing new medical devices within the market.
• Increasing surveillance post the device’s availability in the market.

Implications of the New MDR for Medical Device Manufacturers

The new MDR warrants the need for conclusive and hard evidence that is based on data for existing as well as new medical devices(Lehmann, 2019). It has several implications and would essentially mean that medical device manufacturers have to;

• Setup systems for managing quality and risk.
• Consistently gather clinical evidence for their devices following its market release, to validate the effectiveness as well as safety of the device.
• Provide data reports on a new centralized electronic system which will be easily available to the public.
• Be responsible for determining devices that requires reclassification and those that require additional review by a notified body.
• Setup systems that encompass their financial obligations in the event of unwarranted harm that arises from a defective device.

With the new MDR in force, the objective is to reinforce the rules associated with clinical investigation of medical devices, with a view to improve the availability of valid clinical information. Manufacturers are expected to adhere to stringent regulations with regards to performance, quality and safety of medical devices that they provide.

3.0 Challenges for Medical Device Manufacturers

Under the new MDR, medical device manufacturers are expected to affect substantial alterations in terms of quality assurance, product development and data reporting. Enforcement of the new MDR would mean higher cost implications and extended time required for new product development. Further, the process of clinical monitoring and gathering evidence for recertification of existing products could also prove to be an expensive proposition. Having said that, there are four key challenges(Anastasi & Hill, 2019) that the new MDR poses for medical device manufacturers and these would include;

3.1 Reclassification

As per the new MDR, major modifications will be effected to the classification of medical devices. In this case, requirements would be largely evaluated based on risk it presents to patients. For instance, specific devices that will be used on spinal cord will move up the order from class II to class III. As a process, reclassification of devices will have to undergo expensive process of certification for new products and also recertifying products that are already in the market. The focus of the new MDR would shift from approval of product to its whole lifecycle, warranting higher clinical assessment prior to approval. This would no doubt substantially slow down the production of medical devices.

3.2 High Clinical Testing Needs

Another key challenge that manufacturers are confronted with pertains to the increase in requirements for clinical testing. Owing to reclassification, manufacturers in the past who were not required to execute clinical testing, now need to be able to do so. New regulations also necessitate a reevaluation of clinical data pertaining to devices that already exist in the market. In the event that the data does not match the new requirements, medical devices need to be put through additional testing for recertification. This further augments the cost of sustaining legacy devices.

3.3 High Demand for Notified Bodies

As of now, notified bodies (NBs) acted as consultants in facilitating medical device manufacturers to adhere to the requirements for CE markings. With the enactment of the new MDR, NBs will assume the role of enforcers who will assess all medical devices (other than IVDs), those that fall above class I. However, the shortage of NBs to evaluate devices, specifically in devices classes that are of higher risk, will lead to a delay in approval for products and slow the entry of a device into the market. Furthermore, timelines are bound to be increased considering that NBs have a huge volume of data to review. This in turn, would tend to increase costs on the whole.

3.4 Significance on Post-Market Surveillance

Under the new MDR, much stress is being laid upon post-market surveillance. This would comprise of preemptive monitoring of the performance of medical devices for yearly safety updates for devices falling in the high risk class, recertification and prompt reporting of incidents concerning device safety. This kind of intense monitoring and reporting for safety requires additional resources which would prove to be a strain for medical device manufacturers.

4.0 Compliance

The new MDR presents some disruptive changes that have far reaching implications for medical device manufacturers. With the transition period almost at end, there are several modifications that device manufacturers need to enforce to ensure success of existing and new devices. The extent and intricacy of the challenge presented by the new MDR would require device manufacturers to bring about substantial changes in domains as vast as; data reporting, product development, manufacturing procedures and quality assurance. To comply with the new MDR, device manufacturers can strategize and conduct a gap analysis to identify whether their existing devices comply with the new MDR. Excellent leadership is vital to facilitate the smooth transition to the new MDR while developing a strategy for execution that comprises of preset timelines and techniques to monitor progress with regards to compliance. Medical device manufacturers could setup a core leadership team that would include experts from quality assurance, clinical or medical affairs, R & D, regulatory affairs, manufacturing, labeling, biocompatibility, sterilization and marketing. Members of the team need to establish an active communication with NBs while setting project harmonization between product portfolios and business units(Premier Research, 2019). On the other hand, medical device manufacturers are approaching external entities (Contract Research Organizations) to acquire support and guidance to ensure compliance(Lehmann, 2019).

References

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