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Medical device manufacturers are greatly challenged by the burden of increasing regulatory demands

With the new legislation - the EU MDR now in full effect in 2021 – medical device manufacturers are facing issues and challenges concerning health and risk. Therefore, medical technology companies must adopt stricter quality assurance measures so that individual devices can be speedily tracked and retrieved in emergency situations.


Within the EU, some of the challenges and perceived risks now facing medical device manufacturers result from changes in the regulatory framework, emphasizing safety.

The European trade association for the medical technology industry (MedTech) state that medical technologies can save lives, improve health, and contribute to sustainable healthcare. The medical health literature states, “Medical devices are used for the diagnosis, monitoring, and treatment of virtually every disease or condition, and include familiar objects such as simple bandages to high-end MRI scanners,” regulated by Council Directive (3, 4).

While the EU MDR applies to medical devices in the EU, manufacturers from the rest of the world who wishes to sell their products in this region, also need to adhere to the legislation.

MDR was due to come into force in May 2020, but due to the COVID-19 situation, it has been postponed until May 2021. This gave manufacturers more time and the opportunity to start taking steps to facilitate the transition to MDR.


The most important change

The main change under the new MDR regulations focuses on safety and risk reduction, which is to be achieved by strict processes that lead to market authorization.

Medical technology companies must adopt more stringent quality assurance measures so that individual devices can be speedily tracked and retrieved in emergencies. Among the new requirements introduced by the MDR is creating a unique position to be filled by a candidate with proof of experience in medical device regulations.

This person is to be entrusted with managing all matters related to regulatory requirements.


R&D, Innovation, and Regulation

Medical technologies are characterized by a constant flow of innovation, resulting from a high level of research and development within the industry and co-operation with users. New product development can take from 1 to 2 years in terms of their risk class. Health means are divided into classes I, IIa, IIb, III.

The placing on the market of a new or innovative product depends on the complexity of meeting the essential requirements and, above all, on time required for the conformity assessment by the notified body (NB).

Success in medical device development is determined by the variables of innovativeness, financial analysis and planning, user input in the development process, and company employees' engagement in the new product development (NPD) goals.


Smaller and medium manufacturers will have a hard time

Earlier, we reported on how EU MDR will be making life hard for small and medium medical device manufacturers.

This time, small-medium enterprises (SMEs) will find it challenging to find an employee with such expertise. Moreover, to obtain MDR authorization for class III, implantable devices, and high-risk class IIb, MedTech companies will be required to present a notified body with a large volume of clinical data that supports their products' clinical performance.

From an SME perspective, the new European legislation may result in a significant proportional increase in costs and an increased administrative burned, resulting in the impossibility for some companies to continue developing new products and, therefore, restrain innovation for the development of medical devices.

These conditions involve mainly safety regulations but also environmental protection requirements, and they affect multiple aspects of the development process: technical, clinical, as well as biological. While the demanding conditions may be seen as an obstacle, they may also prove stimulating for innovation.


This situation addresses two important questions:

  • Do advantages from increased regulation outweigh the additional expenses?
  • As many MD developers are SMEs, will the new regulatory regime result in some of those companies going out of business and therefore impede future innovation?

According to this research, the new legislation will result in improved safety, facilitate product recalls, but the cost and administrative burden may be high. The evidence also indicates that some SMEs may be forced to diversify to “non-medical” products, with the inevitable loss of innovative medical devices being made available to patients and healthcare providers.


Will smaller companies migrate or collaborate?

Within the context of the new EU MDR, heavy regulation may be a barrier to the innovation of new medical devices for SMEs. In contrast, regarding larger organizations, such regulation may prove to stimulate innovation.

However, while some SMEs may move away from medical device development to non-medical device products, they may transfer their innovative skills to these products to the medical profession's detriment.

Another solution would be to cooperate in networks, to avoid being swallowed by bigger players in the industry,

It will be interesting to see in which way the industry will move towards.

Medical device companies need to find ways to increase operational visibility internally and externally, enable transparent content and data management across all functions and improve efficiency – especially in clinical, where the number of studies will increase dramatically.


How Minerva can help medical device companies meet MDR compliance standards?
Increased visibility and continuous collaboration between business functions will be key to maintaining the required permanent compliance with the new regulation. Minerva PLM for Medical Device enables companies to unify clinical data management with clinical operations. It puts all data and documents on one system, to enable faster and easier collaboration with one source of truth for shared operational data.

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Do you want to see Minerva PLM in action? Request a demo and get a preview on how your business can benefit. 

About the author

Thomas Skogen

Thomas is an expert in Supply Chain and Manufacturing Optimization with more than 10 years of experience originating from Medical Device and High-Tech & Electronic Industries. He comes with a background as an Electronics engineer, complemented with a Master in Technology Management. Thomas has held positions in multinational corporations such as Nilfisk, heading the internal optimization program as well as the supply chain organization.

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