The narrative had become quite comfortable.
It is easier to get your new medical device through the European Union (EU) regulators than the U.S.’s FDA regulators.
The rules were clear. You knew what to do. Hire the right consultants, get your ISO 13485 certification, pay the price for clinical studies and jump over the regulatory hurdles that gave you access to hundreds of millions of potential customers. The hurdles served as a barrier of entry to your competitors.
A Fundamental Change for Device Suppliers
Then, in April of 2017, the Europeans blew up the narrative by repealing its existing “directives” on medical devices. The new Regulation would go into effect in May 2020. Device companies gulped, consultants cheered and our lines at OTW lit up. Device makers wanted to know what to do.
Device makers will be facing a new set of rules which will fundamentally change medical device commercialization in the EU.
The European Commission is calling this a “soft transition” in the sense that it is supposed to allow companies to keep certain aspects of the current CE Mark applications while following new registration requirements, if their Notified Bodies (NBs) approve.
Sounds good. Except…there are no guidance documents to explain the complicated, interlocking requirements.
What are the Europeans doing and what will it mean for device makers? We dug in.
What Happened?
On April 5, 2017, the Europeans passed the European Union Medical Device Regulation [MDR], (Council Regulation 2017/745 of 5 April 2017 concerning medical devices, OJ No L 117/1 of 2017-05-05). The Regulation repeals the existing directives on medical devices: Medical Devices Directive [93/42/EEC] and Active Implantable Medical Device Directive [90/385/EEC].
Currently approved medical devices will have a transition time of three years [with a staggered transition period until May 26, 2020] to meet the new MDR requirements.
The new regulation introduces new responsibilities for national Competent Authorities (CA) and for EU Notified Bodies.
During the transition period, manufacturers can place devices on the market under the currently applicable EU Directives but must comply with certain aspects of the EU MDR when it goes into effect in May 2020 such as post-market surveillance and vigilance requirements. Manufacturers may also submit their applications to be certified fully under the MDR during the transition period if their NBs are certified to accept EU MDR applications.
New scientific opinions will be required for a host of devices, such as bone cement containing an antibiotic. Any existing product must be recertified to abide by the new regulation.
