The regulatory regime for medical devices, technologies and diagnostics is complex and multifaceted covering:
- matters specific to medical devices such as CE marking, device classifications, clinical investigations, 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 have particular experience helping clients seeking to navigate (and occasionally challenge) the complicated areas of the classification of borderline products.
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 the enforcement is largely left to bodies such as the Competition and Markets Authority. 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 their codes and we have good working relationships with these bodies.
The treatment of commercial matters in relation to medical devices and medical technologies are critical and often complex. For 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.