Impact of EU Medical Device Directive Revisions

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Impact of EU Medical Device Directive Revisions

EU Medical Device Directive Revisions: Regulatory Pathways and Requirements in Ireland 
Health is seen as a key determinant of economic growth in the EU, with the development of cutting edge Medical Device Technologies (MedTech) central to maintaining and improving health and quality of life of its citizens in addition to generating substantial opportunities for job creation and trade [1].

Ireland plays a key role in this sector and as such is recognised as 1 of 5 global emerging MedTech hubs; 18 of the top 25 MedTech companies worldwide have a base in the country, over 29,000 people are employed and annual exports totalling over 12.6 Billion Euros are delivered to 100 countries worldwide [2].

Underpinning successful innovation & translation in the MedTech field is the acquisition of pertinent skills and knowledge. In particular, the regulation of medical devices plays an essential role in facilitating device innovation whilst ensuring product safety and performance.

The governing reEU Mapgulatory framework for medical devices in the EU, the Medical Device Directives [3] [4] [5], are set to be revised to account for advances in medical device technology as well as the recognition of the need for a more harmonised, robust and transparent regulatory system. Analysing and disseminating the impact of these changes will be essential to ensuring that the Irish Medtech sector is adequately prepared to develop and commercialise in accordance with the newly revised EU regulatory requirements. In doing so, this will foster the timely and successful approval of innovative products onto to the Irish and European markets while ensuring the highest levels of product safety and performance. This in turn will ensure competitiveness for the Irish MedTech sector, against the backdrop of a changing regulatory landscape and in the context of an increasingly globalised economy.

Project Aim and Outputs
Molecular Medicine Ireland (MMI) is a partner in CÚRAM, the Science Foundation Ireland (SFI) funded Centre for Medical Device Research based in NUI Galway. This partnership is formalised through the SFI funded project entitled: ” Developing Key Structures and Resources to Support Medical Device Clinical Research in Ireland “. As part of this project MMI will assess the impact of the Medical Device Directive revisions for key stakeholders in the Irish MedTech community, including academic and clinical researchers, as well as industry partners, the Health Product Regulatory Authority (HPRA) and other key stakeholders.

The analysis will focus on, training and information requirements, applicable standards, ethics and evidence requirements (including clinical evaluations and clinical trials) in additional to studying the impact on regulatory pathways & processes for CE Marking and time to market.

The implementation and subsequent impact of the Medical Device Revisions in Ireland will be studied and benchmarked against identified countries of strategic importance in the EU and further afield.

The analysis will be disseminated through various media including website, and social media communications, reports and peer reviewed publications. Furthermore this work will inform the development of future training, information materials and web based tools.

MMI Project Manager, Robert Behan, is responsible for conducting analysis work and for the project management of related development activities. He reports to Lead Investigator and MMI Head of Programmes, Dr Mark Watson. The work is carried out in close collaboration with Professor Matthew Griffin (Professor of Transplant Biology, NUI Galway), Professor Martin O’Donnell (Professor of Translational Medicine at NUI Galway ) and Professor Abhay Pandit (Scientific Director, CÚRAM).

Research is supported by Science Foundation Ireland (SFI) and is co-funded under the European Regional Development Fund under Grant Number 13/RC/2073.

Further Information: Please contact Robert Behan, ( )

[2] Irish Medical Devices Association , “ABOUT THE MEDTECH SECTOR,” 2016. [Online]. Available:!OpenDocument. [Accessed 22 August 2016].
[3] THE COUNCIL OF THE EUROPEAN COMMUNITIES, “COUNCIL DIRECTIVE 93/42/EEC,” Official Journal of the European Communities, vol. 36, no. L 169, 12 July 1993.
[4] European Commission, “Council Directive of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices,” Official Journal of the European Communities, vol. 33, no. L 189, 20 July 1990.
[5] European Commission, “Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices,” Official Journal of the European Communities, vol. 41, no. L 331, 7 December 1998.