MG Regulatory

The UK and EU market is a lucrative 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. I've seen thriving products go through unexpected non-conformances causing huge losses. At MG Regulatory, we have over 10 years 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. In addition to this, we'll also give you free consulting for 30 minutes to prove ourselves before you commit to anything. We provide: - UK Responsible Person. We have a strong relationship with the MHRA and have a specialism in this area. - EU Authorised Representative. We have provided EU AR services to hundreds of clients across the globe and can also act as the EU AR PRRC. - Consulting. We support with all aspects of a technical file including clinical evaluation, risk management, economic operators, post-market surveillance and also deficiency management in the case of NCs found. We are experts in MDR and IVDR across all classifications of devices from surgical instruments to ventilators with AI and everything in between. - Market Access - Ensuring compliance to all local registration requirements in the EU to ensure continued market access in these regions. - Training. We provide training to in-house regulatory teams to ensure skills stay within the company.

• Employees 0
• Founded 2024