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If there is a delay in appointing EU notified bodies under the new Medical Device and IVD Regulations, it will impact the whole sector's ability to comply in time. But nothing is quite ready.





Notified bodies seem determined to make sure that they, at least, are not responsible for any delays in the implementation of the EU Medical Devices and IVD Regulations.



Despite the fact that none of the tools needed for the formal designation of notified bodies under the Medical Devices and IVD Regulations are yet available in final form, many notified bodies are preparing to apply imminently.



Most of the 23 members of the EU trade association for notified bodies, TEAM-NB, are still planning to apply before the end of 2017, Francoise Schlemmer, director of TEAM-NB confirmed to Medtech Insight.



The earliest they can apply to be designated under the new regulations is November 26, 2017.



TEAM-NB is assisting its members to jointly submit applications to the European Commission. Among its efforts, the group is preparing a handbook to support re-designation and associated audits in a standardized way, and is conducting a review of the regulations, focusing particularly on the chapters and annexes directed at notified bodies. TEAM-NB is asking the Commission and national competent authorities to review the applications concurrently under the joint auditing structure and declare the new designations simultaneously.



That said, Schlemmer believes that at most 16-18 of its members will be ready to submit by late November. And given the potential for non-conformities to be identified in some of the applications, the association would be pleased to see 10 of its members get designated against the MDR/IVDR in the first wave.



Schlemmer explained that TEAM-NB members' applications will feature the same answers to many questions with some personalization to reflect the specifics of each individual entity.



Making Use Of Drafts


The Commission's application forms for notified body designations under the new regulations are not yet finalized, but TEAM-NB members are relying on the draft formats, Schlemmer confirmed.



Indeed, none of the tools that are needed for the designation of notified bodies have been finalized.



There has been progress, however. The Notified Bodies Operations Group (NBOG) made public three draft documents in August that will be pivotal in notified bodies applying and being designated under the new regulations. (Also see "Over 170 Provisional Draft Codes Published For Notified Body Designation Under MDR & IVDR" - Medtech Insight, 11 Aug, 2017.) These documents effectively make up three of four draft delegated and implementing acts needed for the designation of notified bodies under the new regulations.



It must be stressed, however, that these documents have not been adopted or endorsed by the European Commission and that the draft implementing legislation has yet to be made available for public feedback.



That said, the first of these, NBOG WD 2017-1 Draft list of documents to be submitted in the application for designation as a notified body under Regulation (EU) 2017/745 and Regulation (EU) 2017/746, spells out the documentation that notified bodies will be required to submit in an application for designation under the new regulations.



The other two draft NBOG documents recently made available comprise 171 codes that could be used to describe a notified body's scope of designation under the regulations – 71 under the MDR and 100 under the IVDR



The documentation that will be needed, according to NBOG WD 2017-1, includes:


  • A compliance strategy explaining how notified bodies have fulfilled the MDR/IVDR, including, in the case of notified bodies designated under the current EU medical device and IVD directives, a gap analysis explaining how the alignment to the new requirements of the regulations has been achieved;

  • Documentation detailing the established (specific) qualification criteria for each function within the conformity assessment process, as well as for the types of devices, technologies and areas within the subdivisions of the scope of designation applied for;

  • Documentation relating to procedures for quotations and pre-application activities;

  • Documentation detailing the conformity assessment body's financial resources, including its financial capacity and long-term economic viability;

  • Documentation relating to procedures for selecting, evaluating and monitoring the competence of subcontractors involved in conformity assessment activities;

  • Documentation detailing the conditions governing the remuneration of all employees (including top-level management and contracted staff) and on fees charged and financial conditions;

  • Documentation related to unannounced audits; and

  • Details on how conformity assessment services are advertised.



TEAM-NB says a guide on the designation process is also needed, along with an additional act, to effectively replace the existing Designating Authorities Handbook.



Notified body designation is among the priority topics for the Commission to address this autumn. Together with competent authorities, notified bodies and industry, it is organizing a roundtable discussion on notified body designation and capacity, to be held on October 6.



Why The Urgency?


This is an urgent matter. There have been repeated warnings that there are going to be bottlenecks at the notified bodies due to the volume of work under the new regulations, in addition to ongoing work related to the current directives, and a shrinking number of bodies operating in this area.



The sooner these organizations are designated, the sooner they can start to provide services to the huge volume of products that will need to be audited under the new regulations.



But predicting when the first notified bodies will actually be designated is tricky. It will not depend solely on the notified bodies, but also on the resources allocated to the joint audit teams – the teams made up of representatives from the European Commission and competent authorities, which review the notified body applications and ongoing designations.



Which Notified Bodies Will Apply First?


TEAM-NB is acting on only behalf of its own members. There are likely to be another 20-40 testing and certification bodies that will apply for redesignation under the regulations that are not members of TEAM-NB. But without the support of TEAM-NB and the tools it has been preparing, notified bodies that are going it alone will have a tougher time and are less likely to be among the first to gain designations. Certainly, none of these organizations have made a fanfare about their readiness.



The TEAM-NB organizations are seeking MDR recognition in 12 countries, and IVDR designation in a subset. (See table below.) In the context of the Brexit discussions, it is worth noting that UK and Irish notified bodies account for five of the 23 organizations that have applied to be designated under the MDR and four of the 11 under the IVDR. A full list of TEAM-NB members is available on the TEAM-NB website.



Countries Where TEAM-NB Notified Bodies Are Seeking MDR And IVDR Redesignation


























Czech Republic




















* All notified bodies applying under the IVDR are notified bodies that are also applying under the MDR

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