Patient Care at risk in the struggle to prepare for the biggest change in EU Medical Device Regulations in over 20 years

The MedTech sector in Ireland has become one of the leading locations for the production of medical device products in the world.  Exports of medical devices and diagnostic products now represent 8% of Ireland’s total merchandise exports and we attract more MedTech FDI than any other nation in the EU.  However, MedTech companies in Ireland now find themselves part of a huge bottleneck as the sector in Ireland and throughout Europe struggles to get to grips with the looming new EU regulatory regime that is the Medical Devices Regulations (MDR) which comes into force at the end of May 2020.

At the heart of the bottleneck is the current lack of approved bodies, known as Notified Bodies, capable of certifying the many thousands of medical devices as being compliant with the new MDR standards.  As of 18 December 2019, only 8 Notified Bodies have been designated in the whole of the EU to certify all medical devices to be placed for use and sale on the market under the MDR. To put this in context, 58 Notified Bodies are currently designated for this same certification purpose under the existing regulations – the Medical Devices Directive (MDD).

Companies anticipating delays, increased costs and uncertainty with respect to gaining MDR certification, have sought to buy time by having their medical device products re-certified under the current MDD regime, thereby allowing their products to remain on the EU market for up to 4 years following the application of the MDR in May 2020. This has resulted in an avalanche of recertification applications across the EU’s network of Notified Bodies thereby stripping capacity from the system and hampering many of the Notified Bodies in their own application process for designation as an MDR approved Notified Body.

This bottleneck effect has resulted in real concerns amongst the medical and MedTech communities-alike, both in Ireland and abroad, that the system will not have sufficient capacity to process the existing applications for re-certification, resulting in the withdrawal of crucial medical devices from the market and putting patient care at risk internationally.

This is not an unforeseen circumstance, in July 2019, the United States issued a statement to the World Trade Organisation’s Committee on Technical Barriers to Trade in which they highlighted the apparent delay to the implementation of the MDR which they felt could result in the withdrawal of US devices from the EU market.  Their statement read, “the United States has serious concerns regarding the implementation of the MDR and IVDR, and 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”.

More recently, MedTech Europe, which represents the EU medical device industry, said in a 26 November 2019 publication that the ‘incomplete implementation by the EU Member States and European Commission threatens the continuity of patient access and care, both in Europe and in the more than 100 countries around the world that rely on the EU CE marking of medical technologies’.

In light of the lack of MDR designated Notified Bodies, rumours are circulating as to a possible delay in the application of the MDR.  We have already seen the ‘go live’ date of Eudamed, the European Database on Medical Devices, delayed for two years along with an extension of the deadline to apply to serve on ‘expert panels’.  In addition, the European Parliament’s Committee on the Environment, Public Health and Food Safety on 3 December 2019 voted to adopt an extension that will give manufacturers of certain up-classified Class I devices an additional four years to comply.  However, at a recent Irish Medtech Association event in Galway, Ireland’s Health Products Regulatory Authority (HPRA) said that no such delays are envisaged for the application of the MDR itself.

Given the vast number of medical devices, of both European and International origin, that must be re-certified under the MDD or certified under the MDR and the lack of Notified Bodies currently designated to certify them, the pressure will only continue to mount on both the EU and overseas industries as the May 2020 deadline approaches.

While Ireland is clearly not alone in struggling to be ready for the application of the MDR (Ireland’s Notified Body the National Standards Authority of Ireland has yet to be designated under MDR) the bottleneck here is significant given the country’s status as a MedTech location and the consequent potential for collateral damage to Ireland Inc’s reputation.

One can only assume that the HPRA and the Government of Ireland now have contingencies in place and are bringing as much influence and pressure as possible to bear on their European counterparts to ensure that no patient has to go without access to a medical device as the result of a failure to ensure a smooth regulatory transition to the MDR in May 2020.

How we can help

BHSM’s Healthcare and Life Sciences Department offer practical legal and regulatory compliance advice to a variety of clients across the medical devices sector.

For further information on how the introduction of the MDR may affect your business, please contact David Scott in the Healthcare & Life Sciences Department of BHSM on 01 440 8300 / dscott@bhsm.ie.

This article is for general information purposes.  Legal advice must be obtained for individual circumstances.  Whilst every effort has been made to ensure the accuracy of this article, no liability is accepted by the author for any inaccuracies.