MG Regulatory

The UK, EU and US markets present huge opportunity for medical device manufacturers but the regulatory environment is tricky.

Even once established in the market, the ever-changing nature of the regulations makes it a continual challenge to stay on top of. We’ve seen thriving products go through unexpected non-conformances causing huge losses.

At MG Regulatory, our consultants have decades of expertise to help medical device companies enter and stay compliant with UK and EU regulations to keep their products in the market.

We are unique in that we act as an internal regulatory partner that will spend as long as you want in understanding your vision, product and ways of working to truly provide a tailored consultative service.

We provide:

US FDA Compliance & 510(k)/De Novo/PMA Support – Preparing submissions and managing QSR compliance for US market entry, whether you’re new to FDA or expanding.

UK Responsible Person (UK RP) – We can act as your UKRP and have a strong relationship with the MHRA as some of our consultants have previously worked there.

EU Authorised Representative (EU AR/PRRC) – We can act as your EU AR and EU AR PRRC as we have represented hundreds of global clients across all classifications.

Regulatory Consulting – Full support with technical files, clinical evaluation, risk management, PMS/PMCF, and managing non-conformities across a wide range of devices from surgical tools to AI-based diagnostics.

Market Access – Handling local EU and US registration requirements to ensure smooth, uninterrupted access to these markets

Training & Capability Building – Upskilling internal RA/QA teams to build long-term in-house regulatory capacity.