Medical Devices Getting to Market Quicker in Ireland

More resources to add staff and new application procedures have significantly accelerated the ability of the National Standards Authority of Ireland (NSAI) to approve medical devices, and get products to market faster. The NSAI approves CE markings for products in Ireland.

Dr John O’Dwyer, European Manager, NSAI, said that increased resources have allowed the Authority to hire additional clinical staff, extra regulatory experts and quality and assurance staff, who carry out audits.

Additionally, the Authority has introduced pre-submission meetings with medical device companies, and this has led to better applications.

The average time to approve an application of a device that is not high risk is now four to six weeks, which significantly helps many indigenous Irish companies – which do not create the same high-risk, innovative devices that multinational firms want to manufacture – get their product to the market faster.

SOURCE: Irish Medical Times