10 September 2018
The EU’s new medical device regulatory framework means that manufacturers of medical devices face major changes.
Ten years ago, the European Commission initiated a public consultation on existing requirements covering medical devices. After talking to a wide variety of stakeholders the Commission released its plan in 2012 to restructure the EU’s medical device regulatory framework, along with a regulation that would replace existing directives for medical devices and active implantable medical devices.
|“The MDR will replace the EU’s current Medical Device Directive. The changes are signficant.”
As a consequence, manufacturers of medical devices who sell within the European Union (EU) are faced with major changes in the EU’s decades-old regulatory framework. The Medical Device Regulation (MDR) was officially published on 5 May 2017 and came into force at the end of May last year.
“The MDR will replace the EU’s current Medical Device Directive (93/42/EEC) and the EU’s Directive on active implantable medical devices (90/385/EEC),” explained Richard Poate, Medical Health Services Business Line Manager at TÜV SÜD Product Service.
According to Paul Jenkins, a Medical Health Service Team Leader at TÜV, “Manufacturers of medical devices that have already been approved will have a transition time of three years until May 2020, to meet the requirements of the MDR and that transition period can be extended until May 2024 in certain circumstances.”
As Poate explains, the MDR differs in several important ways from the EU’s current directives for medical devices and active implantable medical devices.
“Changes include a significant expansion of the scope of products covered, more rigorous requirements for clinical evaluation including changes to clinical investigations, mandatory unique device identification (UDI) mechanisms, and increased post-market oversight by EU Notified Bodies,” he explained.
Looking in more detail at these changes they mean that the definition of medical devices and active implantable medical devices covered under the MDR will be expanded significantly and, according to Jenkins, will include “devices that may not have a medical intended purpose, such as coloured contact lenses and cosmetic implant devices and materials. Also, for inclusion will be devices designed for the purpose of “prediction” of a disease or other health condition.” He continues, “The MDR will also require device manufacturers to review the updated classification rules and update their technical documentation accordingly by considering the fact that class III and implantable devices will have higher clinical requirements and a regular scrutiny process.”
Crucially, manufacturers will now be required to collect and retain post-market clinical data as part of the ongoing assessment of potential safety risks.
“These changes will result in a dramatic increase in the time and resources needed by manufacturers to conduct the required studies and to maintain post-market documentation,” according to Poate.
Also, under the MDR, all currently approved devices will need to be recertified, in accordance with the new requirements.
“Manufacturers with currently approved devices will have three years to demonstrate compliance with the MDR’s new requirements,” explained Jenkins, “although exemptions are under negotiation.”
It is also important to note that, as an EU regulation, the MDR will have the force of law throughout the EU after the date of application. This approach will eliminate country-by-country interpretations of the requirements permitted under current directives and is also likely to speed up the actual effective date of the MDR’s requirements across the EU.
“The complex development process for medical devices, combined with the changes, are likely to make the transition period a complicated and time-consuming process for most device manufacturers,” said Poate.
“Because of these complexities, as well as the impact Brexit is expected to have, we are advising medical device manufacturers to stay current on the progress of the MDR through the regulatory approval process, as well as additional changes that may impact them.”