HOW MDR WORKS

Next year, Europe will introduce new legislation governing medical devices, affecting suppliers and patients alike. Össur News explains the concept of how the new MDR Regulation will work.

Text: Fridah Jönsson

ay 2020 will see the new MDR legislation come into force in Europe. The Medical Device Regulation will re-draw the map for suppliers and providers, and for customers and users of medical devices. The definition of the concept is very broad and includes everything from pacemakers and prostheses to hospital beds and wheelchairs – all types of instruments or apparatus used for medical purposes.

THE MDR REGULATION was voted through in 2017 and, as of May 2020, will replace the earlier Medical Devices Directive (MDD) and the Active Implantable Medical Devices Directive (AIMDD). Users will not necessarily know these directives like the backs of their hands, but there are advantages to being familiar with MDR, as patients will be able to have greater insight into the production of medical devices as of 2020.

are being imposed on suppliers early, as all manufacturers will have to have at least one person who is responsible for ensuring the organisation is compliant with the regulation. The individual in question must have specific expertise in medical devices and must be responsible

for financial oversight, technical documentation, product control and reporting obligations, to which new guidelines will also apply.

The new reporting obligations accompanying MDR will mean, among other things, that product manufacturers will have a duty to publish safety reports about their products providing more up-to-date and current knowledge about the items in question. There will also be tougher requirements for follow-up of how the devices actually work among end-users.

be more rules on transparency and traceability. A comprehensive European database on medical devices (EUDAMED) will be introduced; in this database, manufacturers will be required to register updates about everything from accidents involving the device to ongoing safety information. Some parts of the database will be open to public scrutiny.

PATIENTS WITH AN implantable device will notice a distinct change through the MDR Regulation. Everyone who is given an implant will also receive an “implant card” with information about the type of device implanted. This dovetails with the manufacturers of certain drugs having to report exactly what substances are used in the manufacture of their products, making for greater transparency in healthcare; this will be particularly beneficial for patients with a sensitivity to certain substances.

MDR will entail a number of practical updates. Össur is busy taking stock of all the devices in its range and establishing new contracts with all suppliers in order to ensure MDR compliance. For example, the global quality system will have to be updated, the devices will have to be registered with EUDAMED, and new follow-up methodologies will have to be launched. There is also a strong focus on further developing the work of the global R&D departments to demonstrate the clinical efficacy of the solutions being developed and presented to the market – all with a focus on a safer environment for the individual user and a more transparent and reliable production process.