Overview

MCRA’s team of European experts offer a range of services, including Regulatory Affairs, Clinical Research, Quality Assurance, GDPR Compliance and Cybersecurity, and Representation Services. Our European team of experts are globally integrated to ensure our clients have access to both European and global services.

European Regulatory Affairs

MCRA is Europe's leading regulatory advisor for medical devices and in-vitro diagnostic (IVD) medical devices. The European Regulatory team brings direct industry, Notified Body and Competent Authority experience, across a wide range of device technologies, classifications and novelty. Our in-depth knowledge and combined decades of experience provides access to extensive regulatory guidance and unparalleled expertise in European Regulatory Affairs. Learn more about our European Regulatory Affairs now.

Clinical Research

MCRA’s global clinical research organization enables companies of all sizes to successfully execute clinical studies by streamlining the clinical trial process. Our integrated approach guides clients through the device lifecycle: from pre-clinical testing, to regulatory submission, market approval, and post commercialization, including pre- and post-market clinical activities. MCRA's CRO executes medical device, IVD, and drug /device combination studies in Europe and across other major markets. Learn more about our Global CRO Services now.

Quality Assurance

Medical device companies rely on MCRA’s Quality Assurance experts to meet or exceed the quality assurance standards set by certifying bodies. We guide you through the processes for implementation, audit preparation and execution, and certification, and then maintain quality assurance requirements by adhering to recognized standards to ensure uninterrupted market presence. Learn more about our Quality Assurance Services now.

GDPR Compliance and Cybersecurity

The GDPR safeguards the personal data of European subjects and applies to all Europe-based and non-Europe-based Sponsors that deal with the personal data of European data subjects. MCRA’s certified GDPR experts can provide guidance and support to ensure your medical device company is fully compliant with GDPR regulations and have a cybersecurity strategy and plan in place for both your medical device and your organization. In addition, our experts can support information system security requirements for handling and storing data safely and securely, meeting GDPR and ISO requirements. Learn more about our GDPR Compliance and Cybersecurity Services now.

Representation Services

If a medical device clinical study Sponsor is not based in the EU or UK, they are required to appoint a locally-based Legal Representative. The Legal Representative is responsible for the Sponsor’s compliance with legal obligations and is the addressee for all communications with the Sponsor. MCRA provides Legal Representative services to Sponsors running studies in the EU and UK.

Unique Device Identifier

The MDR (EU) 2017/745 and IVDR (EU) 2017/746 introduced UDI requirements. MCRA’s UDI experts provide an array of UDI-focused activities, including the development of UDI implementation plans, assignment of UDI, delivery of UDI training and review of technical documentation to ensure UDI compliance. MCRA’s UDI experts can also assist clients with the preparation and submission of UDI/Device data to EUDAMED.