EU MDR/IVDR: US Raises ‘Serious Concerns,’ Urges 3-Year Implementation Delay

  • February 18, 2020

In a 24 July statement to the World Trade Organization’s (WTO) Committee on Technical Barriers to Trade, the US discusses the MDR/IVDR issues facing industry.  “Our industry is worried about their continued access to the EU’s USD 125 billion medical device market, USD 20 billion of which is supplied by US products.”

With just about five (5) months left before MDR’s 26 May 2020 date of application, the 24 July statement from the delegation of the US highlights two issues that specifically concern the implementation of the EU’s new regulatory system being behind schedule.  The issues relate to the ongoing lack of notified bodies (NBs) designated against MDR/IVDR to support timely transitions and implementing acts to help ensure compliance with new product standards.

The US urges the EU to delay MDR/IVDR implementation by three years to “allow for US exporters to adapt to the new requirements” due to the concerns it cites in its statement to the WTO’s committee.  “If that is not possible, we urge the EU to allow for legacy products that are currently deemed safe to be sold on the market until 2024 and to ask” that NBs prioritize devices in need of new certification over those being recertified.

The European Commission (EC) has designated only two NBs — BSI UK and TÜV SÜD — against MDR so far and none against IVDR.  It has also set forth only two of the MDR/IVDR implementing acts — just one of which has been adopted so far.  The EC adopted the implementing act on the list of codes for designating NBs under MDR/IVDR in November 2017 and it issued the draft implementing acts on the common specifications for the reprocessing of single-use medical devices in accordance with MDR in July 2019.

The EC still planned to designate 20 more NBs by the end of 2019.  Yet the US says that (*) DG GROW’s expectation is for just 12 NBs to be designated by year’s end, arguing that this total would be insufficient to “ensure continued regulatory approvals by May 2020” and by IVDR’s 26 May 2022 date of application.  [(*) NOTE:  DG GROW – DG for Internal Market, Industry, Entrepreneurship and Subject Matter Experts (SMEs).  The Commission’s Directorate-General for Internal Market, Industry, Entrepreneurship and SMEs is responsible for EU policy on the single market, industry, entrepreneurship and small businesses.]

The US points to the lack of implementing acts in stating that “EU standardizing bodies cannot begin work on developing the standards industry may use to comply” with MDR/IVDR.  The EC’s draft standardization request, which was just posted in June 2019, drew criticism from an industry group that urged EU standardizing bodies to reject the EC’s request in its current form.  “Industry maintains that the product standards necessary for compliance with MDR cannot be completed before the deadline,” according to the statement from the US.

The US statement further argues that the MDR/IVDR provisions intended to provide industry with transitional relief, which include the legislation’s provisions for warehousing and the grace periods, have been “insufficient.”

An EU statement from 18 JUL 2019; however, tells the WTO’s committee that, “there are no grounds for the time being to explore any amendment to the transitional periods.”  On the current status of NBs’ designation, the EU states that the final number of newly designated NBs will be “slightly lower compared to the current situation” and that “it could take some time for many” NBs to submit their applications based on their preparedness level because “one of the declared objectives of the new regulation is to have in place a safer” NB infrastructure.

Gert Bos, executive director and partner at Qserve consultancy, recently explained to Focus what industry could expect from the legislation’s intent to “clean house in the NB field,” which is already happening.  Three (3) NBs have officially or at least temporarily decided against applying for MDR and IVDR, adding to the pile of uncertainty.

Yet, the EU adds that it is “committed to take steps to encourage” NBs to use audit reports from the Medical Device Single Audit Program (MDSAP) “in a manner that is compatible with EU legislative requirements.”  It expects finalizing its work on guidelines for such purposes, which is reportedly already underway, by year’s end (of 2019).

REFERENCE:  Regulatory Focus; News Articles; 2019/8; 02 August 2019; Ana Mulero

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