New EU Medical Device Regulations: Time’s up! Everything your life sciences company needs to know

The transition period for compliance with the legal requirements of the EU Medical Device Regulation, in force since 2017, has been extended until 31 December 2027 for higher risk devices and until December 2028 for medium and lower risk devices. What are the main changes that will be introduced by the new MDR, and what will manufacturers have to do to market their products in the EU?

The life sciences industry includes companies from diverse fields such as biotechnology, pharmaceuticals, biomedical technologies and devices, and research and development related to human health. It is particularly subjected to strict controls and procedures – as it should be, given the potentially crucial impact products could have on our lives. The sector is currently undergoing a disruptive transformation, similar to other business sectors, caused by increasing digitisation, emerging scientific findings and fierce competition among its key players. This new landscape is reshaping the sector, and new legislation is required to keep up with technical advances, changes in medical science, and new characteristics of the sector.

This is the context in which the new EU Medical Device Regulation was born, with the aim of increasing safety and efficiency in the EU medical devices market, of solving weaknesses in the existing legislation, of better matching the current sector background, and of creating a transparent and standardised framework for the industry.

When will the new EU Medical Device Regulation come into force?

The new EU Medical Device Regulation (MDR) has been applicable since 25 May 2017, together with the In Vitro Diagnostic Medical Devices Regulation (IVDR), both of which have replaced the three previous EU directives for medical devices (93/42/EEC, 98/79/EC, and 90/385/EEC). However, to allow the industry to continue bringing essential medical devices to the market and ensure that patients have safe access to medical devices, the current transition deadline under the MDR has been extended to the end of May 2024, while the IVDR’s transition deadlines range from May 2025 to May 2027, depending on the class of the device. Despite the new end date, CPSL would like to advise MD providers to check now for any remaining documentation needs and to not leave it until the last minute. It should be noted that the application date of the IVDR has not changed and that all requirements have been applicable since 26 May 2022, with some caveats.

Which companies are required to adhere to the MDR and IVDR legislation?

The EU has published a series of documents to help companies review their documentation and the features of their devices and to prepare an action plan: manufacturers of in vitro diagnostic medical devices and of medical devices will have to comply with more demanding regulations regarding risk classes and surveillance.

What are the main changes to the MDR?

The new EU Medical Device Regulation is replacing its predecessor and is mainly a guide about how to get CE Mark certification for products, to increase the responsibilities of all the involved stakeholders and to focus on the whole production process for devices, not only on placing them on the market.

Here are some of the significant changes being introduced by the new MDR:

Vigilance and Post-market Surveillance – MD manufacturers must have plans for post-market surveillance and have to implement them into a cycle of continuous evaluation and improvement, which should result in enhanced risk management.
Role of Economic Operators and Person Responsible for Regulatory Compliance – the new legislation describes the different sets of responsibilities that manufacturers, importers and other stakeholders have in the process, with increased liability for all the concerned parties.
Scope and Classification of Products – including rules for software, apps and use of hazardous substances.
Changes impacting Notified Bodies – with a stricter auditing process and the requirement for audits programs to be approved by MD companies.
Device identification – traceability will become a requirement for all medical devices.
Safety and Clinical Performance – for some specific devices, manufacturers will have to conduct a clear and understandable summary of safety and clinical performance.
Clinical Evaluation, Post-market Follow-up, Clinical Investigations – the new MDR will introduce stricter rules on clinical evaluation and clinical investigations.

Manufacturers will have to comply with the new requirements by the deadline, which will apply to devices granted CE certification under the previous regulations and to any new devices. Most companies will have to update clinical data, technical documentation, and labeling.

EU MDR regulation: more thorough labelling

The new EU MDR requires more detailed labelling of products. The labelling will have to include UDI rules (currently required in the US), product serial numbers, the name of a licensed EU representative for manufacturers outside the EU, additional warnings and precautions related to the device, and a list of any medical substances it contains that come from tissues and cells, of any carcinogenic or mutagenic substances, or any substances toxic to reproduction, and a clear symbol to indicate that the product is a medical device. With such extended requirements, companies will have to redesign labels to market their products in Europe after the deadline.

How we can help

Being compliant with EU MDR is a challenge for MD manufacturers and they need to make sure their labelling system complies with the new rules. This includes ensuring that users can obtain information in a language they understand. The information supplied with the medical device must be provided in the official European Union language(s) specified by the Member States in which the device will be made available to users or patients, and it will also have to be available in every language on the company website when this is available.