DDReg Pharma

DDReg Pharma

How is Team AB Gearing up for the new MedTech Legislation?

In the development of the UK’s medical device industry, a consortium of Approved Bodies (AB) united under the banner of the UK Association for Medical Device Approved Bodies, or simply, Team-AB. This coalition marks a landmark as these bodies converge to advocate for cohesive regulations in the evolving landscape of medical device oversight.

The genesis of Team-AB traces back to February 2024, when a cohort of ABs in the UK formally declared their alliance. The aim was to present a unified front in the development of novel medical device regulations within the UK. At the heart of this initiative lies the imminent overhaul of the UK Medical Device Regulations 2002, originally based on the EU Medical Device Directives (MDD), now poised for a substantial update slated to take effect in 2025.

Harmonization and collaboration within MedTech

Following the replacement of the EU MDD with the Medical Device Regulation (MDR), the United Kingdom government has taken a step towards harmonizing its laws in this area and passed legislation in 2021 that will bring it into line with the changing standards. This change in legislation has also led to extensive consultations with stakeholders such as ABs and the MedTech industry. For this year, MHRA is expected to come up with a draft language for a new bill which will bring UK regulations closer to those of MDR.

The significance of this collective undertaking was highlighted by Monisha Philips, the chairperson of “Approved Body” at TÜV SÜD and co-president of Team-AB, which is based on the power of a united voice during consultations with MHRA. The team seeks to align AB interpretations in order to strengthen its impact as well as advocate for a more harmonized understanding of regulatory expectations.

Central to Team-AB’s mission is its role as a channel for collaboration, serving as a platform for applicant and designated ABs to exchange insights on navigating the UK’s regulatory framework. In order to clarify what regulators, expect and facilitate stakeholder participation in the regulations remodeling process, the coalition aims at promoting conversation and exchanging experiences. 

The Chief of Approved Body for BSI, Vishal Thakker and also the co-president of Team-AB had the same idea claiming that the coalition’s power to bring collaboration in communication channels between ABs, manufacturers and trade organizations. In an interview with the EU team, NB–Vishal Thakker argued that this can be replicated in educating manufacturers on MHRA’s expectations to ease market entry.

Fostering a new era for MedTech regulation

MHRA’s legislative trajectory should be influenced by team-AB, with insights from various European counterparts. It was highlighted by Thakker that the coalition is in a peculiar position to mediate between the United Kingdom and Europe on regulation, to enhance mutual sharing of good practices. Team-AB is inclusive with eight ABs and a number of applicant ABs under it ensuring that everyone’s voice is heard when shaping regulations. Monisha Phillips argued for the need to accommodate divergent points of view thus reiterating the importance of lawmaking that can work across all ABs.

Team-AB forges ahead, signifying the beginning of a new era in regulatory advocacy and coherence within the UK’s medical devices industry. With regulatory reforms becoming imminent, Team-AB’s collective voice has become the ray of hope that brings unity to an industry that will define its future on strong standards and common vision. 

With a knowledge base of over 120 regulatory agencies, deep subject matter expertise, industry knowledge, and access to in-house RegTech software, DDReg provides end-to-end regulatory services and safety solutions for medical devices. Reach out to the experts for more information. Read more about medical devices here: Asserting Patient Rights: The Importance of Labels for Medical Device Traceability