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The first implementing act for the EU’s new Medical Devices Regulation (MDR) and In Vitro Diagnostics Regulation (IVDR) is open for comments until next Wednesday.
Implementing acts allow the commission to tease out the intricacies of the legislation and this first one is related to the Notified Body product codes for medical devices and IVDs. The codes, included in the implementing regulation's annexes, are used to categorize the fields of expertise of the NBs and define their scope, according to the consulting company Emergo.
"The significantly changed list of product codes for IVDs is heavily discussed and it is not certain this list will be the final version," Emergo said.
The release of the codes for consultation comes as Notified Bodies will begin applying for designation on 26 November.
RAPS Executive Director Paul Brooks, who in June explained what companies should begin preparing for, told Focus: "Early agreement on the codes is essential to support the timely Notified Body applications and designation of Notified Bodies.
"The codes need to be granular enough to ensure Notified Body competence is demonstrated across technology/products to achieve an appropriate definition of scopes of Notified Body designation, but, also need to be appropriately practical to apply to ensure coverage can be demonstrated and maintained," he said.
Brooks pointed to a significant increase in the number of codes related to IVDs, adding, "It is now most important that Notified Bodies have thoroughly reviewed the new proposed codes and considered how to demonstrate competence when submitting applications for Notified Body designation. From the perspective of EU member states and manufacturers, it is important that a selection of Notified Bodies are able to achieve designation for each and every code (otherwise it will not be possible to get CE marking/market clearance for devices related to those codes)."
According to Emergo, it may take until at least September 2018 before the first NB is designated.
Delorme Corinne, global head of regulatory affairs at France's LNE, commented on the consultation: "It is absolutely necessary to take into account that these codes, beyond allowing product categorization, serve as a basis for demonstrating NB competencies, in particular during the joint assessments."
Additional feedback can be provided until 25 October 2017.
Draft Implementing Regulation
Tags: MDR, IVDR, medical device regulations Europe