Get ready for the new european medical device regulation

The current Medical Device Directive (MDD) that has been in effect for nearly 25 years is 60 pages long. Regulation (EU) 2017/745, the new MDR, is 174 pages long and adds new requirements, which means that compliance in the EU is going to take a lot more expertise. But by understanding the new MDR, medical device manufacturers can get ahead of the curve and keep headaches—and compliance costs—to a minimum.

What Is the New MDR?

The good news is that the MDR is a regulation, which means that it has the force of law all over the single market. Because the MDD was a directive, the EU’s national governments passed sometimes conflicting laws based on the MDD that manufacturers have had to navigate.

The new regulation, delayed to 2021, mainly updates and expands the MDD. Provisions that are mostly updates include new rules for registration that call for much more information about each device and that now require importers to register.

Another such provision will make Notified Bodies play a much stricter and more tightly regulated enforcement role, including by performing more vigorous (and unannounced) audits and inspections. Existing Notified Bodies must all be reaccredited, and many are not expected to make the cut. In addition, the requirements and capabilities of the European Database on Medical Devices (EUDAMED) will be significantly expanded, although the updated EUDAMED won’t go into effect until 2022.

What Are the New Components of the MDR?

While much is familiar, several components of the MDR are wholly new. To begin with, the new regulation has been expanded to cover devices without a medical purpose, like colored contact lenses. More seriously, medical device manufacturers based outside of the EU will be required to designate individuals as Authorized Representatives who will bear personal legal liability for the manufacturers’ compliance. These individuals will be personally responsible for providing technical documentation and incident reports to Competent Authorities under the law. In a further expansion of accountability, all manufacturers will now need liability insurance to be prepared to compensate patients, if needed.

Another new component of the MDR is the creation of a system for Unique Device Identifiers (UDIs) like that in use in the United States. Each device will need an UDI to aid in tracking and to combat falsification. The UDI will be entered into a public database that will expose a fair amount of information, and it will be affixed to the device itself (not just the packaging).

It’s a Whole New Ballgame Post-Market
One of the biggest changes under the new MDR is to the Post-Market Surveillance regime. Under the old rules, there was a great deal of scrutiny prior to approval and then fairly relaxed surveillance and vigilance requirements after approval. That’s all changed. The MDR mandates a continuous “life-cycle” approach to scrutiny of each device and imposes much greater burdens on manufacturers for ongoing performance and safety monitoring and reporting. More rigorous quality control and ongoing clinical assessments will increase post-approval costs, and not just for high-risk devices (although those will require even more resources to keep compliant).

Increased documentation alone will take added time and resources. Summaries of Safety and Clinical Performance (SSCPs) and Periodic Safety Update Reports (PSURs) will need to be produced for every device and posted to the EUDAMED database. Expect to see quality compliance costs rise when the new rules kick in.

Part of the new MDR has already taken effect: the revised Manufacturer Incident Report (MIR) has been required since January 1, 2020. The new MIR mandates standard coding and terminology recommended by the International Medical Device Regulators Forum. For that and other reasons, the MIR should help with vigilance reporting—if you can get up to speed rapidly.

One tool to handle the new MIR requirements is to use an automated quality management system (QMS). The TrackWise Digital Cloud QMS from Sparta Systems already supports EU MDR 2020 requirements, and it incorporates Manufacturing Incident Report functionality. With TrackWise, you can manage core quality and compliance processes in a streamlined, automated system that prevents the errors that come with manual compliance processes. Starting in May 2020, the EU MDR will impose a significant new burden on device manufacturers. Managing quality, complaints, and documents with TrackWise is one way to keep that burden from drowning you in paperwork.