COCIR concerns in the event of a no-deal Brexit

If anybody had any doubts of the damage that Brexit is doing to our UK and EU economies, the following official announcement today from COCIR, should be a wake up call that is already too late.

The date of withdrawal of the United Kingdom from the European Union – 29 March 2019 – is drawing ever-closer. While we sincerely hope that both parties will continue to do their utmost to find an agreement, our industry is increasingly concerned over preparations for a “no-deal scenario”. Such an outcome means that the UK will no longer remain part of the European Single Market. Given recent communications by the European Commission (1), this will have detrimental consequences for our industries in the European Union. Our major concerns are that:
–    UK Notified Bodies, which currently play a critical role in certifying medical devices placed on the EU-27 market, will no longer be able to issue EU certificates. 
–    Non-EU manufacturers that currently have an Authorised Representative based in the UK will have to change to one based in the EU-27.
–    Manufacturers transferring to a new – EU-27-based – Notified Body will need to change how their devices are labelled to reflect the new Notified Body number or face non-compliance with the Medical Device Directives. 
Unfortunately, it appears that the European Commission and the EU-27 Member States are currently not planning to adopt a specific transition period for medical devices (similar to the one planned by the UK). However, we would like to point out that the current timing is insufficient to allow for manufacturers to receive certification by a new Notified Body. Even where a transfer is possible, and new CE certificates from EU-27 based Notified Bodies have only been issued in the last few weeks, re-labelling all their devices would be challenging at best and unfeasible in many cases, particularly for manufacturers with large product portfolios. If devices are not available, even temporarily, the resulting impact on European healthcare systems – and the safety of EU citizens – could be substantial. 
Therefore, in the best interest of citizens, we call on the European Commission, together with Member States, to agree on a limited transition period. This will allow those manufacturers directly impacted by any no-deal Brexit to continue to place devices certified by a UK Notified Body on the market. 
Standard practice for medical devices (2) when changing to a different Notified Body would be to provide six months following the Date of Withdrawal. This would allow the re-labelling of devices after the certificates transition to a new Notified Body. Even 12 to 18 months could be necessary in case manufacturers have to switch to a completely new Notified Body to ensure the necessary time for the re-certification process.
Such a transition would give manufacturers much-needed certainty and ensure that hospitals, healthcare professionals and citizens in the EU see reliable and predictable access to these devices. 
This, however, provides a short-term solution to a long-term challenge. We therefore encourage the EU and the UK to expedite negotiations on a trade agreement that includes the mutual recognition of medical device certification. 

 1 – ec.europa.eu/info/sites/info/files/qa_brexit_industrial_products_en.pdf 
 2 – www.doks.nbog.eu/Doks/NBOG_BPG_2006_1.pdf

COCIR launch new Healthcare Roadmap in Brussels.

There is a great deal of benefit from being connected with our nearest neighbours and being aware of and part of their healthcare initiatives on a broader scale.  We are pleased to publish the latest announcement.

The Integrated Care Alliance (ICA), of which COCIR is a founding member, has launched today its ‘Multi-Stakeholder Digital Health Roadmap’ in support of Integrated Care. The Roadmap is being launched at the 18th International Conference on Integrated Care in Utrecht hosted by the International Foundation for Integrated Care (IFIC).

The Roadmap follows up on the ICA’s successful Call to Action ‘United Towards Integrated Care’ launched in the European Parliament in June 2016. The ICA partners have worked through the points identified in the Call, recommending measures in four key areas; health policy, new care models, skills and training as well the use of digital care technologies. It also identified the need to build capacity to execute these measures at all levels – European, national and regional. The partners are also inviting those other stakeholder organisations that play critical roles in the integrated care value chain to become part of the initiative.

The publication emphasises the vital role that integrated care will play in reorienting healthcare delivery, creating systems designed to meet the needs and demands posed by an ageing population. At a time when budgetary and human resources are becoming increasingly scarce, an integrated care approach directs resources to where they have the greatest impact. Using the principles of integrated care systems engages citizens, makes provisions for patient education and allows primary and secondary prevention along with early diagnosis and intervention. Digital technologies and services can help ensure appropriate care is readily accessible outside the hospital setting.

Nicole Denjoy, COCIR Secretary General, said; “This Alliance will be key to accelerating the successful transition and scaling-up towards an integrated care mode. The multi-stakeholder approach brings the variety of approaches and insights that we need. It also provides the partners with an ideal platform of communication to share best practice and adds to the existing momentum provided by the ICA’s 2016 Call to Action. As one of the founding members of the ICA, COCIR is committed to making the work of this Alliance successful.”

The ICA is committed to strengthening and expanding integrated, sustainable health and care services across the EU Member States. The Alliance is made up of multi-stakeholder experts dedicated to sharing their experience and expertise while providing direction, advice and guidance for establishing and consolidating integrated care schemes.

By 2021, the Alliance aims to make innovative and interoperable digital care technologies central to healthcare delivery and to harmonise sharing of data plans routine in daily practice. The Alliance’s future work is fully aligned with the objectives of the Digital Single Market and Digital Transformation of Health Care in Europe.

For more information, contact:

Nicole Denjoy
COCIR Secretary General
Tel: +32 (0)2 706 8961
Opens window for sending emaildenjoy@cocir.org