UK approved bodies launch Team-AB as MHRA gears up for new medtech legislation

Approved bodies (AB) in the UK have come together to launch the UK Association for Medical Device Approved Bodies (Team-AB). It plans to lobby the government and Medicines and Healthcare products Regulatory Agency (MHRA), as it develops new medical device regulations this year.

On 19 February, a group of approved bodies in the UK announced the formation of Team-AB with the aim of speaking with one voice when it comes to developing new medical device regulations in the UK. The current, UK Medical Device Regulations 2002, based on the EU Medical Device Directives (MDD), is set to undergo a major update that is expected to go into effect in 2025.

As the EU MDD is being replaced by the Medical Device Regulation (MDR), the UK government passed legislation in 2021 to also update its 2002 regulations. That has led to extensive consultations with the medtech industry, approved bodies, and other stakeholders. This year, MHRA is expected to develop draft language for a new bill that would bring British regulations closer in line with the MDR.

“There's a lot of consultation with the MHRA about the draft of the text of that legislation that we can do now as Team-AB rather than as individual approved bodies,” Monisha Phillips, head of Approved Body at TÜV SÜD and co-president of Team-AB told Focus. “That allows us to come together, agree on interpretation on an approved body level rather than as an individual company level, and that holds a lot more weight.”

Team-AB said it intends to act as a forum for applicant and designated approved bodies to share their experiences about the UK’s regulatory regime. Ultimately, the group hopes to develop a more consistent understanding of what regulators expect of them and the feedback they give to stakeholders as the British regulatory regime undergoes reform.

"We just see it as a great opportunity really to drive consistency in approved body assessments, in communication with our regulator and other stakeholders, and other groups, and also an opportunity to start creating guidance and training and engagement across the industry at a time when there's so much changing,” said Philips. “We all know from the EU MDR that it resulted in an awful lot of [Medical Device Coordination Group (MDCG)] guidance documents, and I think that's going to be true of the UK MDR going forward.”

There are several working groups represented by manufacturers, trade organizations, and approved bodies, that have been tasked by MHRA to address different aspects of the legislative changes. As those groups start giving their feedback, Team-AB says they’ll be able to give unified and consistent feedback on behalf of approved bodies.

“The main aim is to have that one single voice to make it easier for MHRA to understand where the approved bodies are coming from and what we want to drive,” Vishal Thakker, head of Approved Body at BSI and co-president of Team-AB told Focus. “It also allows manufacturers and other trade organizations to have that engagement with the approved bodies as a group.”

“What we see at the moment is a lot of the trade organizations will have separate conversations with approved bodies,” he added.

Thakker said they’ll also be able to take their experiences at Team-NB in the EU and how they’ve advised medtech manufacturers regarding MDR and apply that to regulatory expectations for manufacturers who want to market their products in the UK. He added that Team-NB has been very successful in providing training that has been helpful in educating manufacturers in the EU, and he wants to use the same approach to help manufacturers in the UK about MHRA’s expectations.

Thakker said Team-AB can also help drive how MHRA thinks about developing its new legislation and how it harmonizes with their European counterparts.

“Now that MHRA is outside of Europe they have no oversight of what's happening in Europe,” he said. “But Team-AB allows that because most of us are notified bodies as well.

“We know what works well in Europe, what doesn't, and we can take those things to the MHRA and change the ways of working… and vice versa, we can try certain things in the UK and hopefully try and show in Europe to our European counterparts these things can work,” he added.

Currently, there are eight approved bodies and at least two applicant approved bodies, though the number of applicant approved bodies are not made public by MHRA. Thakker said one of the big benefits is that Team-AB will be able to represent the voices of the applicant approved bodies as well.

“Not all approved bodies are built the same and that can impact the nature of how we deliver services,” said Philips. “This allows more voices to come to the table and communicate what is possible under the UK MDR because... what we don't want is legislation that's not deliverable across all the approved bodies.”

“It's really key to have those applicant approved bodies involved and understand the ability for them to deliver these future regulations as much as it is for those of us that are already designated,” she added.

Team-AB announcement

UK approved bodies launch Team-AB as MHRA gears up for new medtech legislation

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