By: Thijs van den Hoven
To tighten protocol surrounding medical devices, the EU set 27 May 2021 as its deadline for all suppliers across the sector to make the switch from the Medical Device Directive (MDD) to the Medical Device Regulation (MDR). With the possibility to extend this deadline once – along with COVID-related delays – many industry actors have yet to begin the long and arduous process. Fortunately, Exact Medical Manufacturing secured its new MDR certification on 18 March 2022, solidifying its position as a leader in the sector.
Changes Across The Sector
On 5 May 2017, the EU announced that the MDR would officially replace the MDD, and that manufacturers would have three years to make the switch and satisfy auditors’ criteria for the new protocol. Though the original deadline, 26 May 2020, was extended by a year due to the COVID-19 pandemic, the vast majority of suppliers are still taking advantage of the option to postpone, selling products produced according to the MDD for an additional four years following the deadline.
But there are major differences between the MDD and the MDR – and most boil down to the MDR being much more complex. The protocol requires more extensive reporting, more audits and, generally, increased accountability. Exact is exceptional as an early adopter of the MDR, and the company already far outpaces most of its industry peers, who have yet to embark on the complex process of making the switch.
No Small Task: Switching To The MDR
Exact’s decision to immediately undertake the transition from MDD to MDR protocol without applying for an extension was bold, but in line with the company’s commitment to excellence through products that serve clients and, ultimately, patients around the world. The process has been a long one, the success of which is owing to the hard work and determination of all involved – especially the Regulatory Assurance team based out of China.
The bulk of their work involved compiling an extensive technical file covering all the procedures currently in place, as well as newly adopted ones. External auditors – like the ones Exact used at the German notified body TÜV SÜD – use this document when carrying out checks to ensure a manufacturer is fully compliant.
Despite the Exact team’s foresight and hard work, things still did come down to the wire. Luckily, the final certification came through just in time on 18 March – and operations were not disrupted. Delays in securing accreditation are common, as a result of a shortage of auditors permitted to carry out checks and grant certifications. Going forward, this will likely cause even more hold-ups across the sector – meaning Exact’s early action will guarantee the continuity of its business throughout the coming years.
One of the biggest questions surrounding the change to the MDR is what the switch will mean for the sector. For one thing, it will ensure stricter regulations that protect patients –one of the major reasons why Exact took swift and early action. It could also mean that the future for smaller suppliers, or ones who fail to act promptly, could prove uncertain.
Exact is proud to have taken this crucial step in continuing to serve its clients around the world. The switch to the MDR means Exact will keep delivering consistency and reliability through its products and services for years to come.