14/04/2020Life Sciences Translations
New EU Medical Device Regulations: Time’s up! Everything your life sciences company needs to know
The EU Medical Device Regulation, in force since 2017, reaches its first milestone on May 26, 2021 (as it was postponed due to the Covid-19 pandemic), when manufacturers of medical devices will have to comply with the new legislation. What are the main changes that the new MDR will introduce and what will manufacturers need to do to market their products in the EU from May 26, 2021?
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 subject 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 digitization, 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 standardized framework for the industry.
When will the new EU Medical Device Regulation come into force?
The new EU Medical Device Regulation (MDR) has been in force since May 25, 2017, together with the In-Vitro Diagnostic Medical Devices Regulation (IVDR), both of which replaced the three previous EU directives (93/42/EEC, 98/79/EC and 90/385/EEC) for medical devices. The two new regulations have been in a transition period since 2017, allowing manufacturers, authorities and notified bodies to get ready to adhere to the changes that will apply in full from May 26, 2022, for the IVDR and May 26, 2021 for the MDR. Despite the new end date, we at CPSL wish to remind MD providers to check now if they have any remaining work with the documentation and not leave it to the last minute.
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 stricter regulations regarding risk classes and surveillance. Companies subject to the MDR must comply by the earlier deadline of May 2020—MD companies need to be fully ready and compliant by that date.
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 gain CE Mark certification for products, to increase the responsibilities of all stakeholders, and to focus on the whole production process for devices, not just putting 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, which they have to implement in a cycle of continuous evaluation and improvement, and 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 parties concerned.
- 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 that auditing programs 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 produce 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.
By the deadline of May 26, 2021, manufacturers will have to comply with the new requirements that will apply to devices granted CE certification under the previous regulations, and any new devices, with most companies having to update clinical data, technical documentation and labeling.
EU MDR regulation: more thorough labeling
The new EU MDR requires more detailed labeling of products. Labeling 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 labeling 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. Naturally, all these factors put additional pressure on companies in the medical devices industry and make the time constraints of the May 26 deadline even more demanding.
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