EU Data Protection Representative
For companies headquartered outside the European Economic Area (EEA) that process personal data of EU residents, appointing a Data Protection Representative is not optional, it is a compulsory legal requirement under Article 27 of the GDPR. iliomad Health Data, with its established presence in Paris, France, and deep roots across Europe, acts as your designated European Data Representative, serving as the primary point of contact for both data protection supervisory authorities and data subjects whose information you process. This representative function is frequently a regulatory requirement explicitly mentioned in clinical trial documentation such as Informed Consent Forms (ICFs), investigator site agreements, and privacy notices provided to study participants.
Why Appoint a Data Protection Representative ?
The EU Data Protection Representative ensures trust, accountability, and regulatory dialogue between your organisation, EU data subjects, and Data Protection Authorities.
Key responsibilities include:
Under Article 27 of the GDPR, organizations established outside the EEA that offer goods or services to EU residents or monitor their behavior must designate a representative within the EuropeanUnion. This requirement applies regardless of whether payment is involved and extends to clinical trial sponsors, digital health companies, medical device manufacturers, and research institutions processing EU personal data. Non-compliance can result in significant regulatory penalties and may prevent lawful data processing activities within the EU.
Your EU Data Protection Representative serves as the official, designated point of contact for all 27 EU Member State data protection supervisory authorities, plus the EDPB at the European level. When authorities conduct inquiries, request information, or initiate compliance verification procedures, the DPR handles all communications on your behalf ensuring timely, accurate, and professionally crafted responses that protect your interests while maintaining cooperative relationships with regulators.
The DPR receives and manages Data Subject AccessRequests (DSARs) from EU residents, providing complete, end-to-end management—from initial intake and identity verification through assessment, coordination with your internal teams, response preparation, and timely delivery within the mandatory one-month timeframe. This includes requests involving access, rectification, erasure, restriction, portability, and objection rights.
When data breaches occur, time is critical; theGDPR requires notification to supervisory authorities within 72 hours of becoming aware of a breach. The DPR provides expert assistance throughout the breach notification process, helping you assess whether notification thresholds are met, preparing notification submissions in the appropriate language of the relevant EU Member State, and managing communications with affected data subjects when required.
The GDPR requires that your Data ProtectionRepresentative's contact details appear in various public-facing and regulatory documents including privacy policies, privacy notices, informed consent forms, clinical trial documentation, and data processing agreements. The DPR ensures all relevant documents accurately reference representation services with correct contact information, appropriate language, and compliant formatting.
Maintaining accurate, comprehensive, and currentRecords of Processing Activities (RoPA) is a fundamental GDPR requirement that demonstrates accountability and transparency. The DPR maintains and regularly updates your RoPA on your behalf, ensuring these critical compliance documents accurately reflect all processing operations, legal bases, data categories, recipient disclosures, retention periods, and security measures.
How iliomad Health Data Can Help You
iliomad Health Data, headquartered in Paris, France, is strategically positioned to offer data representation services to support your projects throughout the European Union with its current establishment.
FAQs
Our frequently questions
An EU Data Protection Representative (EU Rep) is a legally mandated point of contact appointed under GDPR Article 27 by organizations established outside the European Union that process personal data of individuals in the EU. The EU Rep acts as your official interface with EU data protection authorities and data subjects, ensuring regulators and individuals have a reachable contact within the EU even though your organization is based elsewhere. This is a legal compliance requirement, not optional, for non-EU organizations meeting the Article 27 criteria.
Non-EU organizations must appoint an EU Rep if they: (1) offer goods or services to individuals in the EU (regardless of whether payment is required), or (2) monitor the behavior of individuals in the EU.
In practice, most non-EU life sciences companies operating in Europe require an EU Rep: biotech sponsors conducting EU clinical trials from non-EU jurisdictions, MedTech companies selling devices in European markets, health tech platforms offering services to EU users, pharmaceutical companies with EU-based clinical research sites, genetic testing services available to EU residents, digital health applications processing EU patient data, and any non-EU organization working with EU-based CROs, hospitals, research institutions, or healthcare providers.
No. Appointing an EU Rep fulfills the Article 27 requirement to maintain an EU-based contact point, but it does not substitute for broader GDPR compliance. You remain fully responsible for lawful processing, valid legal bases, appropriate security measures, data subject rights fulfillment, breach notification obligations, and all other GDPR requirements.
An EU Rep (Article 27) is required for non-EU organizations to provide a contact point within the EU. A DPO (Article 37) is required for certain organizations (whether inside or outside the EU) that conduct large-scale processing of special category data or systematic monitoring. Many non-EU life sciences companies need both: an EU Rep to fulfill the Article 27 contact requirement, and a DPO to oversee compliance and interface with authorities on substantive matters.
We typically begin with an initial assessment within one week of engagement. For urgent regulatory matters—such as authority inquiries, clinical trial blockers, or due diligence preparation we can mobilize immediately to address critical compliance gaps.
Any Questions ?
