MEDICAL DEVICE MAKERS based in Ireland are ramping up their recruitment measures to meet stringent new EU regulations that are just months away.

US manufacturer Cook Medical is hiring 20 new full-time roles in its Limerick base, which is largely responsible for compliance with the EU’s Medical Device Regulation (MDR).

“These roles are part of a larger recruitment drive globally, specific to the EU MDR,” Sinead Burke, director of regulatory affairs at Cook Medical Europe, told Fora. “We have also taken on over 70 new contract roles globally to help with the implementation of EU MDR.”

The MDR is a set of new rules passed by European lawmakers in 2017 that will introduce much stricter clinical reporting and post-market surveillance responsibilities for device makers.

Recruitment at Cook Medical is mostly around roles in regulatory affairs and engineering to meet this new system.

Burke explained that “key changes within the regulations required us to invest in these new roles” to put more emphasis on clinical and post-market clinical follow up procedures.

She said the regulation change will have a “big impact” on all six of Cook Medical’s manufacturing sites worldwide.

“(It) will integrally change the way we work in a lot of key areas of our business, but we are fully committed to making sure we are compliant and embrace this new legislation as a positive step.”

Medical device giant Stryker is also carrying out a similar strategy. The firm, which employs more than 3,500 people in Ireland, is recruiting engineers and project managers at its Cork plant specifically for MDR work.

Medtronic, the world’s largest medical device maker that is formally headquartered in Dublin, declined to comment on its recruitment efforts, but a spokesperson said it has “created a comprehensive implementation plan to transition our products to the new regulation”.

The company has a number of people working on compliance vigilance in its Ireland operations.

Preparedness

While medical device makers are making strides in being compliant, there are still many areas of the system that are concerning the industry, particularly in relation to notified bodies, organisations that are designated by the European Commission to certify devices for the market.

While the legislation was passed in 2017, only seven notified bodies have been approved. There are dozens across the European market.

This slow pace has led to fears of limited resources to meet the rush to get devices checked by May 2020 to avoid any shortages of products.

Cook Medical’s Burke said that the company has been advocating a more streamlined approach to the notified bodies system.

“The timeline set out within the regulation at the notified bodies means to date (seven) notified bodies have been designated with only seven months before date of application,” she said.

“There are much fewer notified bodies than previously, with some recent fallout and an increase workload on notified bodies, which makes for a worrying trend.”

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Written by Jonathan Keane and posted on Fora.ie