— Case Study —

Helping a Drug-Device Combination Product Navigate EU and UK Regulations

Introduction

This case study demonstrates how we supported an established European pharmaceutical company in bringing a new drug-device combination product to market in both the European Union and the United Kingdom. Drug-device combination products are subject to complex and evolving regulatory requirements, requiring manufacturers to navigate both medicinal product and medical device legislation, engage with notified bodies, and meet country-specific submission requirements. Our team provided the regulatory strategy, technical expertise and submission support needed to achieve a successful and efficient market entry.

The Challenge

An established pharmaceutical company based in the EU launching a new drug-device combination product in Europe and the UK.

Our Comprehensive Approach

A cross-functional team of experts was assigned to prepare the submission from both a device perspective and for the UK registration of a medicine.
Co-ordinated with the original manufacturer of the device to be combined with the drug and worked together with the client and third-party manufacturer to develop the required evidence to meet the GSPRs as outlined in EU MDR 2017/745.
Liaised with notified bodies to secure Notified Body Opinion on the device.
Prepared UK dossier and submitted to the MHRA for approval.
Managed the product as an MAH via Taw Pharma, part of the regenold group of companies.

Benefits

The client was able to fill a gap in their organisational competency and was also able to access the UK market through our services.

Solid submission reduces the likelihood of RFI or notified body non-conformances.
Reduced cost due to faster submission and no need for permanent staff to fill the gaps.

Conclusion

The success of this project demonstrates our ability to manage complex regulatory pathways for drug-device combination products across both EU and UK frameworks. By combining regulatory expertise with close collaboration across manufacturers, notified bodies and authorities, we helped our client achieve a streamlined submission process and accelerated market access.

For companies developing combination products or seeking support with EU MDR compliance, notified body engagement, or UK regulatory submissions, our team provides end-to-end guidance to ensure efficient, compliant market entry.