FAQs
Answers to frequently asked questions below
General Question
If you’re developing, manufacturing or commercialising a medical device, the field is incredibly regulated. It’s important to ensure every move you make aligns with regulatory requirements. We help you navigate UK, EU MDR and FDA requirements, reducing regulatory risk and accelerating market access.
Yes. We carry out regulatory classification assessments and provide documented justifications where a product falls outside the scope of UK MDR, EU MDR or FDA medical device regulations.
Yes. We provide UK Responsible Person services for non-UK manufacturers placing medical devices on the Great Britain market, ensuring compliance with UK regulatory requirements.
Yes. We act as your EU Authorised Representative, fulfilling the legal obligations required for non-EU manufacturers placing devices on the European market under the EU MDR.
Yes. We provide UK Regulatory Importer services, including importer verification, documentation review and acting as the UK importer contact in accordance with UK regulations.
We provide regulatory support for:
- UK (UK MDR & UKCA)
- European Union (EU MDR & CE Marking)
- United States (FDA)
We support manufacturers with regulatory strategy, device classification, Technical Documentation, Quality Management Systems, clinical evaluation, risk management, post-market surveillance, UKRP, EU Authorised Representative and Regulatory Importer services.
Yes. We support manufacturers with FDA regulatory strategy, device classification, submission planning and ongoing compliance for the US market.
Yes. We support companies of all sizes, from early-stage innovators developing their first product to established manufacturers expanding into new global markets.
Yes. We deliver tailored regulatory training for teams of all sizes, covering UK MDR, EU MDR, FDA requirements, ISO 13485, post-market surveillance, risk management and other key regulatory topics. Training can be customised to your products, processes and business needs.
By engaging with us early, we help define the correct regulatory pathway, identify compliance gaps, reduce costly delays and provide a clear roadmap to successful market access.
Our consultants have worked across the entire medical device sector, including the WHO, MHRA, Notified Bodies, start-ups, global manufacturers and leading consultancies. We combine the expertise and professionalism of a large consultancy with a hands-on approach, working as an extension of your team and integrating seamlessly into your company culture.
At MG Regulatory, we provide expert regulatory guidance for medical device manufacturers seeking access to the UK, EU, and US markets.