The medical device industry is under constant pressure to innovate and yet remain price competitive. Protecting, defending and enforcing intellectual property, securing collaboration partners, obtaining market access and managing public procurement, advertising and product liability issues are just some of the challenges that we help our clients overcome.
With the distinction between drugs, devices, advanced therapies, cosmetics and even foods becoming ever more blurred, and increasing compliance requirements, our experienced team can advise on the regulatory aspects of developing and commercialising the very latest medical device technology, as well as on protecting innovation through enforcing patent and other rights across jurisdictions.
Our international team supports clients to prepare for new regulatory changes, some of which will have a significant impact on the medical device industry over the next few years. In particular, we are helping clients to prepare for the EU General Data Protection Regulation (GDPR) ahead of its implementation in May 2018, and for the transition to compliance with the new EU medical device regulations (MDR) (which entered into force in May 2017).
With more and more products qualifying as medical devices under the MDR (including certain products of a cosmetic nature, products limited to the prediction and prognosis of disease, and devices merely investigating a physiological state), our team of experts can provide practical advice on qualification under the MDR across our clients’ product portfolios. Our close relationships with national industry bodies and health authorities also means our international team is best placed to advise on implementation of the new MDR on both a national and pan-European level.
With the increasing digitalisation of everyday life, and mounting cost-pressures across all jurisdictions, digital health technologies are set to revolutionise healthcare, whether through patient-facing apps, physician assistance software, institution software solutions, or digital hardware. We have the expertise and experience to advise on the specific issues facing digital health products and businesses, and have created a microsite which aims to highlight some of the key considerations that will need to be borne in mind, including regulatory requirements, intellectual property protection, use of big data, collaborative development and commercialisation opportunities, raising investment and commercial risk.
Our international life sciences team also advises on:
- pan-jurisdictional compliance requirements for the promotion and advertising of medical devices;
- supply chain arrangements including importation and distribution;
- interactions with healthcare professionals, healthcare organisations and patient associations in both local and cross-border settings;
- research and development agreements, and pre-marketing contracts;
- borderline qualification (between medical devices and medicinal products, biocides, food supplements and cosmetics respectively);
- classification of innovative devices, and compliance with conformity assessment rules;
- market access and reimbursement;
- product liability considerations and litigation;
- vigilance and post-marketing requirements for all stakeholders in the supply chain;
- anti-counterfeiting strategies;
- compliance with anti-corruption legislation and other corporate crime issues;
- securing patent protection and enforcing these rights
- international trade mark filing and prosecution services for branded devices;
We have dedicated life sciences lawyers in growth markets for medical devices production and consumption such as China and the Middle East, as well as throughout our European network. Our lawyers are actively involved with medical device trade bodies in -their jurisdictions (such as the ABHI, beMedTech, SNITEM) as well as supranational bodies such as MedTech Europe, so are ideally placed to assist with new challenges and opportunities as they arise.