The EU legislation of medical devices is changing. The MDR regulation comes into force and replaces old directives in a year. The main goal of the regulation is to increase consistency and transparency by enhancing several existing requirements. However, there is nothing about the change that Teampac’s clients need to worry about.
What is the MRD regulation?
MDR is an EU level, standardizing regulation change, which removes the need for national interpretation from medical device legislation by replacing existing directives (93/42/EEC and 90/385/EEC) with a new MDR regulation (Medical Devices Regulation) that applies to all EU countries.
The regulation covers the requirements of the directives, but also introduces new ones. There will be changes concerning classifications, for example, and the scope of the regulation is also broader than before. A quality management system will become compulsory, even though certification is not required. The regulation also improves product traceability and increases industry transparency.
Teampac offers support
Teampac has prepared for the change well in advance by enhancing its expertise and certifying its quality management system. We are fully prepared for the execution of all required changes.
Our ISO 13485 certified quality management system functions as a tool for fulfilling the regulation requirements. We are happy to support our clients through the entire product process, including issues within the remit of the company bringing the product to market.
What does the change require at the product concepting stage?
The regulation’s main impact is on documentation. Clinical evaluation has been required in the past, but the new regulation may introduce stricter criteria.
The products’ technical file needs to be updated to ensure compliance with the new legislation’s requirements. The current so-called Essential Requirements document (ER) will become obsolete. It will be replaced with newly formulated requirements about product efficiency and risk evaluation.
The new classification rules within the regulation must also be checked. This includes reviewing the class in which the medical device is registered and whether the new rules affect the product classification.
What does the change require after product launch?
Changes regarding production itself are minor. In addition to the concepting stage, the regulation will have the greatest effect on the post-market monitoring of medical devices. The goal is to increase transparency and facilitate the design and production of safe devices.
Product traceability is improved with Unique Device Identifiers (UDI). An open European register for data collection is, however, still under construction. A similar system is already in use in the US under FDA.
The company launching the product must also have a plan for actively collecting feedback on the product for further development.
When does the change come into force?
The current transition period continues until 26 May 2020, after which all new medical devices must comply with the MDR regulation. For some devices, the transfer period will be extended until May 2024 or 2025. Based on legislative transition periods, old products will be updated gradually through re-registration.