We all know that the healthcare landscape is undergoing significant transformation. Today’s patients and clinicians are savvy consumers, demanding access to trusted product information to make informed decisions about health care. In parallel, government organisations are supporting patient safety through regulatory mandates around product traceability.
To me, one of the biggest changes on the horizon will be new EU requirements for product information. If you are not already preparing for this major new requirement, start now – the clock is ticking.
So where are these new data requirements coming from? The new European Medical Device Regulation (EU MDR) will establish a robust, transparent, predictable and sustainable regulatory framework for medical devices to ensure a high level of health and safety whilst supporting innovation by establishing Eudamed, the European UDI database.
On May 25th 2017, the new EU MDR came into force and replaced the Medical Devices Directive (93/42/EEC) and Active Implantable Medical Devices Directive (90/385/EEC). One year from now, by May 25th 2019, you need to have updated your technical documentation and processes to meet the requirements. These changes combined with a complex development process for medical devices make the transition a complicated and time-consuming process.
As you will may know, the Regulation affects all medical devices sold in the EU. Different timelines apply to the physical labeling of products, based on risk classification. During a period of 18 months after the date of application of Eudamed, the database must be filled with data on the rest of the devices that are placed on the European market.
The go-live date for Eudamed is set on March 26, 2020. On that date Eudamed will be functional for medical devices as well as IVDs. From May 26th, 2020 for medical devices, and May 26th, 2022 for IVDs, it is required to enter new or modified data in Eudamed, including data that is directly linked to these records.
From speaking to manufacturers, large and small, I know some will be ready for this transition – but others need help. The new requirements, coupled with existing regulatory and compliance responsibilities, can seem overwhelming.
As someone who has a deep knowledge of product information requirements, I see opportunities for medical device manufacturers to distribute validated and authentic information in compliance with different regional requirements to hospitals, clinics and group purchasing organisations worldwide.
By leveraging existing, regulatory connections, such as FDA GUDID and the NHS connections, and combining this with the existing GDSN expertise, I believe it is possible to find efficient ways of complying without reinventing the wheel.
But, if you’re like us, you like to be ahead of the game. This means preparing and validating medical device product information before the compliance deadline, giving you more time to focus on producing the high-quality products that your customers and patients love.
2020 is fast approaching. The best advice I can offer is to start thinking – and acting – now to ensure you are ready for Eudamed.