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Balancing Safety and Innovation –  How European Medical Device Regulation Influences R&D

There have been concerns about device safety in the European Union in the last few years due to serious issues with medical devices. These safety concerns and associated product failures have affected thousands of people, with the affected devices posing a significant risk to the health and safety of their users.

In response, the European Union put the European Medical Device Regulation (MDR) in place, and it came into effect in 2021. It aims to achieve several objectives to ensure higher patient safety and protection. Its effects are being felt across the healthcare industries, including in the research and development field. In this article, we discuss these effects, specifically in R&D.

It Imposes Additional Requirements and Stringent Measures

The MDR has introduced stricter requirements for medical device testing, development, and approval. It mandates that all R&D efforts align with these new and stricter standards. The result is the need for additional research and testing to meet compliance requirements.

These requirements and measures also impact companies manufacturing medical devices for sale and use in the EU. To ensure compliance, these companies must appoint a European Authorized Representative responsible for ensuring all such manufacturers comply with all relevant regulations, including those governing the development and safety of devices used for in-vitro diagnostics.

Larger corporations are opting to appoint subsidiaries that provide this service, but many manufacturers are working with third-party organisations that do the same.

The Introduction of a Risk-Based Classification and Evaluation System

The MDR also introduced a risk-based classification system for all medical devices. These systems being in place means that requirements for performance and clinical evidence for each device can vary depending on its risks.

This affects manufacturers because their R&D teams and processes must put additional effort and emphasis on measuring, assessing, and mitigating risks associated with all the devices their companies manufacture. This will ensure they are safe to be used by a large group of patients without any concerns. 

Even in cases where the risk is sufficiently high, medical professionals will have the information they need to inform their patients and potential device users of them. This will allow the patients to make informed decisions regarding whether they want those devices or not.

Additional Requirements for Post-Market Surveillance

The MDR also requires that all manufacturers must be able to conduct continuous post-market surveillance of all their devices. This provision means they must and will be able to identify and mitigate any risks associated with their problems before they become bigger problems.

To do this, R&D teams must develop and implement systems that allow their companies to collect and analyse post-market data. The use of unique device identification, increased surveillance, and the mandatory appointment of a regulatory compliance office all mean there will be improved post-market traceability and audits, but an increase in the cost of medical devices. 

The manufacturers will likely pass this on to their users and patients, with some estimates saying it will cost an extra €7.5bn to implement this system. MedTech Intelligence has also reported that some manufacturers say it will cost them about 5% of their annual European Union revenue.

Increased Clinical Evidence Requirement

The MDR is also placing a greater emphasis on clinical evidence and clinical trials. Manufacturers are required to provide robust clinical evidence to support the safety and efficacy of all their devices. The result is R&D teams being required to design and conduct much larger and more complex clinical trials than they did before.

In doing so, they must also collect more complex data and use new analysis systems that meet these clinical evaluation requirements as stipulated by the European Medical Device Regulation.

Aligning with Economic Operators’ Responsibilities

The MDR also defines four “economic operators”.  These operators share some responsibility of ensuring all the medical devices they import, manufacture, and distribute for sale within the European Union are compliant.

These four entities are:

  • Manufacturers – A person or entity that manufactures or refurbishes a device and sells it under their name or trademark. Under the MDR regulations, they might also design, manufacture, or fully refurbish existing products.
  • Importers – These are people or entities who are established within the European Union who bring devices from a third country into its market.
  • Distributors – A distributor is any person or entity on the supply chain that is not the importer or manufacturer who makes any medical device available in the European Union market.
  • Authorised representatives – a person (either a natural or legal entity) based in the EU who has been given written consent by a manufacturer located outside the EU to act on their behalf for specific tasks related to complying with MDR.

Each of these parties plays a role in getting a product to users. This means the R&D team and their activities must align with their responsibilities, ensuring that all the devices they are responsible for, either by manufacturing or getting them to users, comply with the set regulations.

Compliance with Data Privacy and Security Regulations

Since R&D teams and manufacturers will be collecting post-market data that includes patient details, the MDR requires they have measures in place to ensure patient privacy and data security. These must be in place during the development, use and post-market audits of the products they develop.

Better Monitoring and Verification of Medical Devices

The MDR has also established a central European database for medical devices. National authorities will use it to monitor and verify the medical devices in their respective markets and the broader EU market. Used this way, the database will facilitate collaboration between EU member states.

R&D teams will also have access to the database to use the data collected by all authorities to improve products or ensure they remain compliant.

The European Medical Device Regulation is significantly impacting R&D within the European medical device industry. It is doing so by enforcing stricter device manufacturing requirements, mandating better and broader clinical trials and data, ensuring better post-market monitoring, and introducing unique identification systems geared towards enhancing patient safety.