With fewer than two months left before the anticipated application deadline, the EU Commission submitted a proposal to postpone the MDR’s compliance date by one year in response to COVID-19. The proposal cited the “unprecedented challenges” the novel coronavirus has created in the industry and pointed out that “Member States, health institutions, economic operators, and other relevant parties will not be in a position to ensure the proper implementation and application of that Regulation” by May 26, 2020. After approval from the EU Presidency, Parliament, and Council, Regulation (EU) 2020/561 was published in the Official Journal of the European Union on April 24, 2020, formally replacing Regulation (EU) 2017/745 and postponing the application date to May 2021.
It’s important to note that other relevant dates—the application date for the In Vitro Device Regulation (Regulation (EU) 2017/746), the date needed for the UDI to be on the label, and last day of the MDD grace period—have not changed with the MDR.
Should Your Life Sciences Firm Press Forward With MDR Compliance?
Yes, companies have gained an extra year to comply with MDR requirements. However, life sciences consulting firms recognize that the current delay doesn’t mean it’s time to pump the breaks on remediation activities. Remember, the MDR went into effect in May of 2017—this means companies have up to the application date to comply with the regulation, but can operate under the MDR now if ready. Many companies are choosing to stay with the momentum built over the past three years of work and drive necessary compliance activities to closure sooner rather than later.
The MDR is a complex regulation, so having extra time to better align with Notified Bodies, or delve deeper into industry guidance, will only promote a higher level of quality and compliance with the regulation. At a minimum, it’s important to understand the implications of the new environment in which we are all operating. Some essential questions to ask while aligning resources and developing a compliance strategy include:
If your life science organization does decide to proceed, make sure to get a clear understanding of your new operating environment to inform future strategy and decisions.
Enterey’s team of life science consultants recognize that the constantly evolving MDR terrain can prove challenging for our partners. Understanding some of the most salient background details on the program can help your organization recalibrate its efforts moving forward.
U.S. medical device manufacturers who want to continue to market their existing products or place new products on the EU market after May 26, 2021, need to work now to implement the new regulatory requirements. Transitioning manufacturers will need to assess core processes including quality assurance and risk management. This blog looks at how the MDR will impact U.S.-based companies’ ability to export devices into the EU, and the changes coming with the MDR of which device manufacturers should be aware.
New Rules and Significant Changes From the MDD
The regulatory changes will see the definition of a medical device significantly broadened to include non-medical and cosmetic devices, which were not previously regulated. Devices such as colored contact lenses, liposuction equipment, epilation lasers, and cosmetic implant devices will now come under the regulations. Additionally, active implantable medical devices and device-specific cleaning products are also covered by the MDR. Many medical devices will also be reclassified as higher risk, and a new classification for reusable surgical devices has been created.
Under the new rules, manufacturers need to:
To give manufacturers an idea of the scope of the changes made to these regulations, the new document is four times longer than its predecessor, and the wording has been changed considerably.
Implementation of Unique Device Identification
The MDR mandates the use of unique device identification (UDI) mechanisms. This requirement is expected to increase the ability of manufacturers and Authorities to trace specific devices through the supply chain and to facilitate the prompt and efficient recall of medical devices that present a safety risk.
UDI will be enforced to help track devices throughout the economic operator supply chain and will be added to all labels.
Enterey’s Life Science Consultants Can Help Your Team Navigate Through Shift MDR Mandates
Enterey’s team of high-performing life science consultants specialize in customized quality and regulatory solutions that keep pace with rapid industry shifts. In the face of increasingly complex regulatory changes and competing business priorities, we recognize that delivering on your promises requires an organizational culture rooted in compliance and transparency.
Our in-depth knowledge of the evolving regulatory landscape in the U.S. and abroad allows us to rapidly diagnose compliance gaps, assess potential quality risks, and develop a foundational quality culture within your organization. Contact us today to learn more. Or take our Process Improvement Plan assessment to determine the strengths and possible weaknesses within your life science organization.