The MHRA's recent announcement of plans to create a new Early Access service to support medical device manufacturers fast-track the process of commercialising their innovations and bringing them to market will have a major impact across the sector. The scheme will allow selected medical devices, which address "defined unmet needs," to be supplied to the NHS for a time-limited period prior to receiving full regulatory approval.
Navigating change in a regulated industry
A policy change in a regulated industry such as the medical device space can have dramatic consequences for those navigating the various stages of their commercialisation project. The Early Access scheme will permit limited market access for designated medical devices which have completed clinical investigation but are yet to complete approval processes. Manufacturers will therefore have to reprioritise accordingly depending on what stage of their project they are at.
A global trend toward flexibility
Such tendency towards softening regulatory hurdles is not particular to the UK. Due to concerns over scarcity and burdensome procedures, the European Commission has opened a public consultation focused on the current legal framework governing medical device approval in the EU. As with the MHRA, the Commission are keen to simplify the process and boost innovation.
Legal considerations from the outset
With some medical devices now potentially entering the market at an earlier stage than anticipated, this reinforces the need for innovators to account for legal and regulatory considerations from the outset of their project.
Supporting innovation through expertise
MFMac recognise the importance of taking the right decisions at the right time along the complex journey of bringing a medical device to market. Our passion for promoting innovation has inspired us to create our comprehensive Medical Device Lifecycle, which outlines essential legal and practical considerations for manufacturers at each stage of the commercialisation process.
Staying compliant in a changing landscape
With an ever-changing commercial and regulatory landscape, it is vital to ensure that you remain compliant and maximise opportunities by keeping up to date. Please reach out to one of our many experts who have the knowledge and ability to advise on issues across all stages of the medical device lifecycle to help your project flourish.
