Medical devices expert warns of regulatory threats

REGULATORS of the Irish market must ensure those operating in the medical devices sector are not hampered by over-regulation.

In a highly competitive market regulators have to be extremely careful that necessary safeguards do not hinder the functioning of this sector in Ireland.

Dr Dan Schultz, director of the Centre for Devices and Radiological Health in the US Food and Drug Administration made these observations in Dublin yesterday.

Speaking at IBEC’s Irish Medical Devices Association (IMDA) annual conference, he said it is important to “minimise avoidable constraints on beneficial innovation”. It was also important for regulators to communicate the risk benefit of medical technology products, he added.

Welcoming Dr Schultz’s comments, Sharon Higgins, IMDA director noted there were over 26,000 people in Ireland directly employed in medical technology product manufacture. Up to 90% of the products are exported.

“In a world where ‘first to market is king’, the challenge for Europe and Ireland is to develop safe and beneficial medical devices and diagnostic products ahead of the competition,” she said.

Products for manufacture in five years’ time are often pipedreams at this stage, she said. That is how dynamic and competitive the market is and over-regulation was not in the sector’s interest.

“It is paramount that legislation safeguards patient safety and public health. However, it is equally important for the continued development of Ireland’s medical technology sector to eliminate unnecessary controls, administrative work or delays in putting new products on the market,” she said.

Effective regulation should boost economic prosperity, developing a competitive marketplace and an efficient, healthcare sector, she added.