We have mentioned many times before that the Health Products Regulatory Authority (formerly the Irish Medicines Board – IMB) is about to introduce fees for distributors of medical devices. This will happen this year – 2016 – though the fees may only be payable from 1st January 2017, we’ll have to wait and see.
The reason the HPRA gives for the imposition of fees on distributors is “the introduction of fees at national level to recover the cost associated with our medical device regulatory activities”. The new EU Regulations governing the manufacture, sale and distribution of medical devices finally comes into force this year, possibly by as early as June 2016. The HPRA as the Competent Authority in Ireland is responsible for the monitoring of the safety and performance of medical devices throughout their lifecycle. In it’s role as market surveillance authority, the HPRA monitors medical devices after they are placed on the market and currently conduct audits at medical device manufacturing facilities, amongst other regulatory activities in this area. The Regulations will introduce new requirements and obligations for all economic operators, including distributors. As such, the HPRA will be required to monitor the compliance of medical device distributors with the requirements laid down in the Regulations, which are anticipated to essentially constitute Good Distribution Practice (GDP) for medical devices.
What will this mean for distributors? Apart from the annual fee, distributors will be subject to having their supply chain operations audited by the HPRA. So what will an audit entail? HPRA conducted a Pilot Inspection Programme for Distributors of Medical Devices recently with a view to determining an appropriate inspections protocol when they go “live” with distributor audits in 2017.
IMSTA have invited HPRA’s Darren Scully to provide an update on the distributor pilot inspections programme for medical devices – key findings and recommendations in line with the medical device revision as the text currently stands – at a business breakfast briefing on 11th May next. This is really important so register early, we’re anticipating a huge turnout. Confirm your attendance now by emailing firstname.lastname@example.org a.s.a.p.
We hope to be able to organise a follow-up business breakfast briefing shortly after the above which will be aimed at providing guidance on how members can comply with any recommendations the HPRA may have for distributors.