EU MDR/2017/745 Implementation Date is May 26, 2020… Are you Ready?
The new Medical Device Regulation 2017/745 was voted on and approved by the EU in April of 2017. It replaced two Medical Device Directives [MDD] and expanded the list of devices that fall under the regulation.
While the goal of the change is admirable; to improve product quality and patient safety, the implementation has not been. With less than 6 months to the effective date, few of the over 400,000 original medical devices covered have been recertified [and all need to be]. The problem is not the lack of desire by manufacturers, but the lack of certified Notifying Bodies that can review. The regulation still has three medical Device classifications [I, II, III] but the amount of documentation and technical information is significantly more. The good news is that while the date remains the same, the regulatory bodies responsible recognize that not all devices or parts of the regulation can/or will be ready by the effective date. That leaves many device manufacturers in the state with a dilemma: cram to meet the deadline, or ‘kick the can down the road’ until compliance is absolutely necessary.
Depending on the classification of a device, there is a third option: Review compliance with the new regulation and implement the necessary changes over the anticipated two-year window that regulators may allow for compliance. It’s hard to predict what the final outcome will be [and Oh, don’t forget that the United Kingdom is exiting the EU on January 31st] but the reasons for the change are valid and device makers would be wise not to delay putting an action plan together and make the effort now to comply before the chaos that will ensue once the regulatory bodies start enforcing.
Below are some of the major changes to how medical devices can be marketed and sold in the EU:
Recertification: All medical devices must certify that they are compliant with the new regulation. There are no grandfather exceptions. Keep in mind that the 400,000+ number includes those devices registered under the MDD. They do not include the number of products that now fall under the regulation, or new products being introduced. And then there’s the UK.
EU UDI: Like the FDA, the EU decided that each device will need a Unique Device Identifier [UDI], but they have not adopted the FDA model, so there will [could] be two sets of UDI’s for each device.
Post Market Surveillance [PMS]: The regulation requires more than just a toll-free continuously improve. All this info will be in EUDAMED, a single database for regulators, Notifying Bodies and consumers to access.
EUDAMED: The centralized database [clearinghouse] for all the medical device information. Already postponed for at least two years…again, those working toward compliance will hit a brick wall here. So, where do you go to recertify? Good question, there is no clear answer.
Quality and Risk Management: Not ISO 13485:2016 certified? The regulation adopts this ISO certification as a minimum for all devices. Risk Management which is part of all recent versions of ISO standards requires management to have an active program that reviews risks and implements plans and programs to eliminate them from the device throughout its entire life-cycle.
Technical Documentation and Labeling: The level of disclosure is much deeper and the labeling and instruction for use must be in the local languages and the list goes on and on. Needless to say, after reading the entire regulation and its 123 Articles and 17 Annexes, it’s clear that whatever documentation and clinical testing a manufacturer may have done, it’s probably not enough to be compliant with the new regulation.
Importing and Distribution: Finally, the biggest impact on everyone in the supply chain is the requirement that all participants within the EU must make sure that their supplier [whether manufacturer, importer or distributor] is compliant to the new regulation. Everyone is responsible for monitoring everybody else.
What are the best next steps to take? The first step is establishing an understanding of the current standing of a manufacturing business and what needs to take place to meet the new regulatory requirements. NJMEP can conduct an assessment of New Jersey manufacturing operations and provide the necessary gap analysis to put together an action plan that makes sense for that unique operation. Since 2000, NJMEP realized more than $3.8 Billion in Value. NJMEP has helped manufacturers, including medical device makers, become more productive, profitable, and compliant in the ever-evolving global economy.