Just because the European Commission extended for two years the effective date of the European Database on Medical Devices doesn't mean manufacturers should sit back and wait.
The database, known as Eudamed, is meant to be a collection of information on devices sold in the European Union that will be used to monitor their safety and performance. The data will be accessible by regulators, notified bodies, scientists and the public.
The aim is to improve transparency and coordination of information on medical devices available on the EU market after high-profile safety snafus involving breast implants and metal hip replacements.
Eudamed was supposed to "go live" in March 2020 but the Commission late last month said it would delay the go live date until May 26, 2022.
The industry is already on edge about a dearth of notified bodies and other concerns related to the ramping up to the new rules.
But even if the database isn't ready, device makers need to get their data in shape now, experts say.
"Understanding how the data is collected in their own individual organizations, what the sources of those data attributes are, and how they will maintain it" are all areas that manufacturers need to pay attention to, Pooja Parekh, a manager at KPMG, said. "So establishing all of those processes, that's the work that can be done right now."
A Commission spokesperson said the delay will now coincide with the implementation date of the in-vitro diagnostic regulation to make sure all systems are in sync.
"The Commission concluded that it will only be possible to make Eudamed operational once the entire system and its different modules have achieved full functionality and have been subject to an independent audit," Sophie Dupin De Saint-Cyr, press officer for Internal Market, Industry, Entrepreneurship and SMEs & Regional Policy for the European Commission Spokesperson's Service, told MedTech Dive.
Eudamed is a massive data undertaking requiring uploading of information for every individual device, its data and attributes, sold in the European Union. Manufacturers must comply with requirements on Unique Device Identification and data registration, economic operator/actor, clinical Investigation reporting, and vigilance.
Each of those has different data elements that must be uploaded to Eudamed.
"If a competent authority conducts an audit or inspection, all information needs to be there," Ulf Grundmann, an attorney with King & Spalding in Frankfurt, told MedTech Dive.
Good news, bad news
Because manufacturers vary in the maturity of their data collection capabilities and efforts, the delay is good news for companies with data in disarray.
Some companies may not have IT infrastructures in place, or they may not have very clean data, Parekh said.
"They may need to go through a cleansing process and mapping process and collection process," she said.
The Eudamed delay will also benefit companies with products that can still be placed on the market under existing certificates, Fabien Roy, an attorney with Hogan Lovells in Brussels, said.
"It's good news for some clients with [certificate] validity dates beyond 2020," Roy said. "It's additional flexibility for them since the provisions of the EU MDR related to post market surveillance, market surveillance, vigilance registration of economic operators and medical devices will not be applicable until Eudamed is working."
They can benefit from the soft transition and continue to place their product on the market until their certificate under the older Medical Device Directive expires, he said.
What needs to be done now?
Companies need to assess which staff members needs to understand Eudamed; who needs to implement the system; what IT skills are needed; and who needs to be trained, Richard Houlihan, CEO of Eudamed.eu told MedTech Dive.
For the basic preparation and conversion of the initial data, Eudamed.eu estimated it would cost companies approximately 150,000 euros.
"Preparing for Eudamed is not simply a one-off exercise," Houilhan said, noting the cost estimate does not include the maintenance, monitoring and system upgrades that will be required.
Yet despite the huge amount of data required, Parekh said they haven't seen companies ramp up their hiring.
"For now, we are not seeing hiring more staff," she said. "It's more about looking at, can we streamline something? Do we have processes in place? We're seeing more interest in relooking at the product information management and other platforms to see if they can automate some of these things. So more and more, we're seeing automation coming into space; it's less about putting more bodies or hiring more staff to support the Eudamed requirements."