13 Apr 2022

Regulatory Advocate needed now

The UK Government has released a response (https://lnkd.in/eEQrWhH9) to the recent MHRA consultation on the regulation of medical devices.

HIRANI CEO, Joann Rhodes said: “Now more than ever we need a regulatory advocate for Northern Ireland. 

Innovative NI medical device companies are not being given any bespoke forum, and often they do not receive relevant advice.

We don’t have a seat at the EU or UK tables to listen to changes, let alone influence and advocate for our companies.

There is no mechanism decided yet for NI based companies to avail of dual market access to both EU and UK, and we are disappointed this does not seem to be a priority for the governments involved.

This leaves NI companies route to either market unclear, stiffling investment and decision-making. 

We need an NI appointed regulatory advocate urgently, to hold people to account and to stop the sidelining of NI regulatory affairs which is stunting the growth of our sector.

The NI health and life sciences industry is worth £1.2 billion and provides 190,000 jobs.”