Regulatory Challenges in Molecular Diagnostics: An Overview

Working in Regulatory Affairs is never boring. We’re in a space where the ground is shifting beneath our feet and not just little tremors – the whole landscape is in flux. The changes are greatest in Great Britain and Europe but, the advantage is that these things move slowly, so with a bit of proactivity, it’s not too difficult to stay aware of what’s going on.

In this post, we briefly explain recent changes in the regulation of In Vitro Diagnostic (IVD) Medical Devices in GB and EU, describe the introduction and impact of In Vitro Diagnostic Regulation (IVDR (2017/746)), and describe the benefits of working towards harmonisation of regulatory requirements.

Regulation of In Vitro Diagnostic (IVD) Medical Devices

As a result of the COVID-19 pandemic, more people know what an in vitro diagnostic test is and have an opinion on the advantages of molecular diagnostics over other types of IVDs, such as lateral flow tests.

Taking a look at the classification rules of the EU’s IVDR (2017/746) will give an insight into the diverse range of IVDs available, of which molecular diagnostics are a small subset.

IVD medical devices are regulated products globally and there are a lot of different requirements depending on the country in which manufacturers wish to sell their tests. Requirements relate to providing evidence that tests are safe and effective, which is usually based on a) the risk the test poses to the individual being tested and b) the risk of the disease being testing for; both to the individual and to the wider population.

The driving force behind the EU Medical Devices Regulation (MDR) and IVDR , is that products that may not have been at the standard of quality and efficacy required will not be approved via the new process and therefore removed from market, reducing risk to patients and improving the general quality of medical devices available to the patient population.

EU rules and outlook

Ask any IVD Regulatory professional where they were on 26th May 2022 and they will be able to give you a very specific answer. That was the date when the IVDR (2017/746) entered into force. IVDR is a revolution in the regulation of IVD medical devices in Europe. Everything changed; from how IVDs are classified, to how conformity assessment works and, importantly, how long it takes to get a product CE marked. Manufacturers who had not been exposed to working with notified bodies suddenly faced that new contractual relationship, plus a whole lot more documentation to prepare, a new review timeline to incorporate into their go to market strategy, not to mention some significant extra costs to cope with.

IVDR (2017/746): considerations

Now the Regulation is in force, there are other challenges to face. Transition timelines were defined and then the Commission announced a new plan to extend them on 23rd January 2024. Stakeholders have concerns – from notified bodies who now have the capacity but are finding manufacturers are reluctant to use it, to patient advocacy groups who can see shortages and removal of products from the market on the horizon.

MedTech Europe, the industry body for medical device manufacturers across Europe, recently wrote an open letter to the European Commission highlighting that, despite six years of implementation, structural issues with the regulatory framework are preventing the MDR and IVDR from achieving their goals to provide “a robust, transparent, predictable and sustainable regulatory framework that ensures a high level of safety and health while supporting innovation”.

QuantuMDx is not alone in facing significant barriers and delays in its efforts to transition products to IVDR compliance. Current expenses involved in the conformity assessment process can exceed the projected return on the products, especially for SMEs. This risks reducing the variety of products on the EU market and could even result in the removal of some of the more niche products, that serve small patient populations, from the market entirely.

It’s clear there is still work to be done by all parties to strike a balance as it seems the EU system, in this regulatory upheaval, is some way away from equilibrium yet.  

IVD regulation in the UK: rules and outlook

In Great Britain, molecular diagnostics are regulated within the wider scope of IVDs in Great Britain and Ireland under the Medical Device Regulations (2002). That regulation is based on the IVD Directive (98/79/EC) and it basically separates tests out into three categories; List A, List B, and General IVDs.

The vast majority of tests fall into the General IVDs category, which means that the manufacturer is responsible for declaring the safety and efficacy of their products and applying their own safety mark. Technical documentation is prepared and filed but is not submitted to any regulatory authority or designated third party for review. As has already happened in Europe, that approach is changing and we’re starting to understand the direction MHRA are moving in more clearly.

Medicines and Healthcare Products Regulatory Agency (MHRA) approach

MHRA published a consultation on new proposed regulations, followed by a response to that consultation in June 2022 . The general intention behind the proposed regulation seemed to be an alignment with EU IVDR. Divergence did, however, appear in a few places, including device classification and the recently announced intentions to accept devices with regulatory approvals from other places like CE-mark and FDA approval; regulatory reliance.  These are interesting proposals; GB is a small market and it makes sense to facilitate the route to market, ensuring our patients have access to the best products possible. How that works practically will be very interesting to see.

MHRA, in their position as a sovereign regulator, can come up with a streamlined, efficient method of regulating IVDs (and other medical devices) that works to the patient’s benefit and fosters innovation without raising financial barriers. The Swiss regulatory authority, Swissmedic, are in a similar situation right now, working hard to foster regulatory reliance to ensure their patient population benefit from the best products available.

Harmonisation of regulatory requirements

Harmonisation of regulatory requirements across the world would make a lot of regulatory professionals very happy and a lot less stressed. Some experienced and respected regulators, including MHRA and FDA, have programmes for harmonisation in which they are actively working with others to foster alignment. The International Medical Device Regulators Forum (IMDRF), and other groups, bring regulators together to co-operate on the harmonisation and convergence of medical device regulations internationally, a move which can only help ensure that regulations continue to align.

Compliance, and the documentation associated with it, will be more streamlined and efficient as a result. That would, in turn, allow manufacturers to spend more time and money on innovation and improvement, improving patient and end user experiences and outcomes and allow regulators to focus their resources on the high-risk products.


We’ve seen the European system under stress trying to implement a huge change in the way medical devices including IVDs are regulated leading to confusion and uncertainty. Manufacturers face difficult decisions in where and how they launch their products but, those who have been in the industry for a while recognise the pendulum swing and there is a general feeling that this is just the way of the world. QuantuMDx are just one of a multitude of small to medium enterprises trying to navigate through these challenges and we know we share frustrations with our peers. We’re optimistic that MHRA will learn the lessons arising from the EU regulation implementations and, until our local regulatory waters become a bit calmer, we’ll take a leaf from Dory from Finding Nemo’s book and ‘Just keep swimming’.