Medical Devices, Medical Technologies and Diagnostics
The regulatory regime is complex and multifaceted covering:
• matters specific to medical devices such as CE marking,
clinical trials (and hospital use), supervision obligations
and marketing restrictions; and
• general matters such as unfair commercial practices,
procurement requirements, anti-corruption and
competition issues. We regularly advise clients in
relation to these matters and aim to develop a tailored
strategy to navigate the regulatory landscape.
This can be challenging where the implementation of EU requirements is inconsistent. By way of example, while most European jurisdictions confer on competitors a right
to commence proceedings for unfair commercial practices, under the UK Consumer Protection from Unfair Trading Regulations enforcement is largely left to bodies such as the Office of Fair Trading. Consequently, in the UK, many such cases are based on intellectual property rights rather than unfair commercial practices.
Industry bodies such as the ABHI and EUCOMED play an important role in the sector and have developed Codes of Business Practice that can be used as an alternative mechanism for resolution of disputes between competitors. We have experience advising in relation to these codes and we have relationships with these bodies.
The treatment of commercial matters in relation to medical devices and medical technologies are critical and often complex. By way of example, there are challenging issues as regards the suppliers of components to medical device companies where the component is not a medical device.
IP issues regarding medical devices are also challenging and critical in order to protect the investment in the development of the product. In particular, non-traditional means of protecting elements of a medical device are increasingly used as a result of the challenges of patenting methods of treatment or diagnosis.