Regulatory and quality affairs

The medical device and diagnostic industry operates in a highly regulated environment to ensure the consistency of the product manufactured. Within the Irish Medtech Association, two groups act in tandem to lobby on behalf of the sector on regulatory and quality issues. The Irish Medtech Association’s Regulatory Steering Committee informs regulatory policy on behalf of members and lobbies at the most senior level both nationally and in Europe, interacting with the EU Commission, Council and members of the European Parliament. The Irish Medtech Association’s QA/RA Forum, along with the Irish Medtech Association’s Regulatory Steering Committee, lobbies on behalf of the sector acting as a conduit for information on regulatory issues. The Forum provides regular opportunities for learning and networking for QA/RA professionals in the sector.

Currently the medical technology sector in Ireland is facing two major issues, namely the implementation of MDR/ IVDR and Brexit, both issues will incur significant additional burdens for medtech companies over the coming years. Successful and timely implementation of the new Regulations is a top priority for the industry and the Irish Medtech Association and it’s members.

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