Challenges within the European MedTech Market: How MCRA’s Experts Stand Out

Written by: Peter Bowness, Vice President, Regulatory Affairs & Operations - Europe

The European medical device market is the second largest, after the United States. Serving over 30 different countries, including the UK, it grosses roughly 150 billion Euros alone each year [Source: MedTech Europe]. Companies in the European MedTech market know that they face different challenges from the US market, especially in terms of regulatory, GDPR and legal requirements. We explore how MCRA sets companies up for success, from startups to major organizations, throughout Europe.

The UK and EU regulatory process has shifted drastically over the last decade, due to new regulations for the medical device and in-vitro diagnostic medical device markets, as well as Brexit. These changes have led to new or expanded requirements for existing devices on the market and new devices across the board. Regulatory bodies are preparing for transitional deadlines, and medical device companies need to take steps now to ensure their legacy devices remain on the EU and/or UK markets. MCRA’s experts, led by former BSI notified body leaders, understand these new requirements, and can guide companies through this process. Our experienced team can help navigate these ever-changing regulatory waters and save organizations precious time and money throughout the device’s lifecycle.  

Clinical research in European markets may seem daunting at first glance. Besides the standard challenges that come with any clinical trial, companies must also take into consideration several factors when running studies in these markets: language barriers, identifying the correct demographics, and country-specific regulations. With the new MDR and IVDR regulations, running a smart clinical trial is now more critical than ever. MCRA’s clinical experts can help organizations identify the optimum approach to generating clinical evidence, the best countries for your trials, assist with enrollment and site locations and management, and break down any country-specific regulations, including General Data Protection Regulation (GDPR) requirements.

GDPR requirements are a big challenge that companies must face when dealing with patients/subjects in Europe. Stricter than the US HIPAA laws, GDPR requirements entail detailed security measurements, accountability obligations, data transfers, and regular contact with authorities. The amount of work required to be GDPR compliant may seem overwhelming for medical device companies. MCRA’s team is GDPR certified, and able to guide companies through the process to be compliant.  

Finally, Legal Representation in the EU and UK markets is a vital step of the clinical study process in these markets for non- EU/UK companies. If a medical device study Sponsor is not based in the EU/UK, they are required to appoint a representative within the EU/UK. The Representative is responsible for the Sponsor’s compliance with legal obligations and is the addressee for all communications with the Sponsor provided for in the Regulations. MCRA’s experts provide these Representative services to Sponsors running studies in Europe and the UK.

MCRA’s experts can lead organizations looking to break into or maintain their presence in the EU/UK MedTech markets. Our wealth of knowledge and expertise, led by former regulators with decades of experience, enable rapid market entry, and meet all the regulations across the medical device lifecycle.

Learn more about our European MedTech Services here.