A Permission, Not a Position

Introduction

The meeting we have most often with international MedTech, HealthTech and GovTech companies goes like this.

The product works. It works at home, at volume, with real users and real outcomes. Regulatory approval is either secured or close. A UK entity has been incorporated, a country manager has been hired or is being recruited, and the board has released a budget for eighteen months of market development.

The question they arrive with is which framework to get on.

It is a reasonable question and it is the wrong one, and the reason it is the wrong one is the single most useful thing we can set out here.

What approval settles, and what it leaves open

Clearing MHRA or securing a UKCA mark is a permission to place a product on the market. It is not a position in that market, and the regulator has no view on whether anybody should buy it.

That gap is not a gap in the regulatory system. It is the design. The regulator asks whether a device is safe and performs as intended. The buyer asks a completely different set of questions, in a different building, to a different standard of proof, and answers to those questions cannot be found in the regulatory file.

This is the point at which MHRA and regulatory consultants — who have done their work well and completely — are asked a question that sits outside their remit. What happens now? And the honest answer is that nothing in the approval process was designed to prepare a…