Why is it Essential for EU and UK Market Access
Legal background
Operating in the EU and UK markets means adhering to one of the most rigorous regulatory frameworks in the world. Manufacturers, importers, and distributors are required to meet strict compliance standards not only regarding product safety and performance but also in their contractual, branding, and data management practices.
Non-compliance with EU medical device regulations can lead to serious consequences.
Without proper legal guidance, you may:
- Violate regulatory requirements due to unclear contractual responsibilities.
- Face trademark disputes if your brand is not registered or protected in the EU or UK.
- Risk non-compliance with GDPR, especially when handling personal data.
Professional legal compliance services ensure you meet legal standards across product safety, branding, contracts, and data governance strengthening your reputation and securing your market position.
Our services
Expert legal support you can rely on
Obelis can provide you with legal services to support your European operations, whether you are a medical device manufacturer, importer, or distributor. Our legal team can assist with:
- Legal analysis of EU laws relevant to your product and company structure.
- Issuance of official statements for regulatory or contractual purposes.
- Review of agreements and provision of templates, including Quality Agreements.
- Trademark registration with the EU Intellectual Property Office (EUIPO) or in the UK.
- Trademark research and clearance to ensure your brand identity is protected across the EU.
- Assistance with GDPR matters, including identifying applicability, obligations, and implementation best practices.
FAQ
Frequently Asked Questions
Obelis offers end-to-end legal compliance services tailored to EU regulatory frameworks. These include EU Responsible Person services, CE marking support, Product Information File (PIF) preparation, technical documentation reviews, safety assessments, regulatory audits, labeling and claims validation, and ongoing regulatory monitoring. Our services ensure full compliance with EU directives and regulations for medical devices, cosmetics, food supplements, and more.
Obelis supports a wide range of industries, including:
- Medical Devices & IVDs
- Cosmetics & Personal Care Products
- Food Supplements & Nutraceuticals
- Chemical Substances & Biocides
- Consumer Goods & PPE (Personal Protective Equipment)
We work with manufacturers, importers, distributors, startups, and EU-funded research consortia navigating regulatory complexities in the European market and providing EU regulatory legal services.
Obelis combines 35+ years of regulatory expertise with a deeply client-centric approach. As one of the largest EU Responsible Persons, we offer unmatched access to regulatory intelligence, a multilingual team of experts, and proactive compliance solutions. Our reputation with EU authorities, commitment to transparency, and personalized support make us a trusted partner in navigating compliance, efficiently and confidently.
Getting started is easy. Simply contact us through our website or email us with your inquiry. Our regulatory experts will assess your needs and provide a tailored proposal based on your product type, market goals, and regulatory obligations. Whether you need a single compliance service or full regulatory representation, Obelis ensures a smooth, compliant path to the EU market.
