NSAI to speed up CE marking

THE National Standards Authority of Ireland (NSAI) is targeting the €115 billion medical devices industry with a major investment that will speed up CE marking.

CE marking indicates conformity to the legal requirements of EU directives. By providing one of the speediest CE marking approvals in Europe, the NSAI is hoping to increase foreign direct investment into Ireland.

To enable this the NSAI, which has certified over 100 medical device products in the past year, will now establish a European headquarters for medical devices certification.

Ceo of the NSAI, Maurice Buckley said many multinational medical device companies consider Ireland as a “stepping-stone” into the EU.

“NSAI is comprised of highly experienced technical staff and regulatory experts dedicated to helping these clients achieve the development of safe and effective devices.

“It is critical, however, that Ireland looks to the future and invests further in a knowledge economy, based less on manufacturing and more on developing the intellectual property involved in developing these medical devices.”

Mr Buckley was speaking at a conference, entitled Medical Devices to Market: Real times, real issues yesterday.

Minister for Trade and Commerce, John McGuinness said at the event: “The medical device industry is already one of Ireland’s great success stories. Half of the top 25 global medical device companies have a presence in Ireland, over 140 companies make and provide key components and services to the medical device sector, exports exceed €6bn and the industry employs more than 25,000.

“NSAI is recognised as one of the leading notified bodies in Europe and NSAI Inc, based in Nashua, New Hampshire, is among the top three providers of medical device system and product approvals in the US.”

According to Mr Buckley the NSAI, has reduced certification time by up to 50%, giving companies a competitive edge in getting products to market.