Europe Regulatory

Entering the European and UK Markets 

When preparing a new MedTech innovation for entry into the EU or UK markets, it is important to understand the different guidelines for your regulatory submissions.  In Europe, organizations will apply for a CE Mark to ensure their device meets regulatory requirements. In the UK, organizations will apply for a UKCA mark for their class II and III devices. Both markets require an approved or notified body to review submissions before being cleared for market entry.  

What is CE and UKCA Marking and Why Does It Matter? 

CE marking is a mandatory conformity mark that allows medical devices to be marketed and sold in the European Economic Area (EEA) and Turkey (Customs Union Alignment). It demonstrates that a device meets the General Safety and Performance Requirements (GSPRs) and other requirements of the EU Medical Device Regulation (MDR) 2017/745. In the United Kingdom, this mark is called the UKCA, and goes through a similar process to ensure it meets safety requirements. Navigating the complex landscape of EU MDR and UK MDR can be challenging. At MCRA, we specialize in helping manufacturers bring medical devices to the European and UK markets by guiding them through every step of the CE and UKCA marking process.

Our Experience in European Regulatory

MCRA is one of Europe's leading regulatory advisory firms for medical devices. Whether you're launching a well-established technology, a novel Class I device, preparing a comprehensive technical documentation file for a high-risk Class III implantable, or maintaining your CE certification, MCRA will deliver tailored, end-to-end support to ensure regulatory compliance,  and successful market entry in Europe and the UK.
 

Our EU Expertise

Our European Regulatory team brings direct industry and Notified Body 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. Former Notified Body highly experienced technical and regulatory experts provide direct insight into the European regulatory systems, optimizing success and mitigating development risks. State of the art knowledge and continuous evolution ensure our experts remain at the leading edge of regulatory expertise. We can support you during the review process after receiving deficiencies or nonconformities from your Notified Body by collaborating with you to develop well-structured, scientifically and regulatory-sound responses that maximize the likelihood of approval. MCRA can also engage from the initial design stage to provide critical regulatory input, ensuring all requirements are considered early in development, or during the preparation of technical documentation prior to submission to Notified Bodies.
 

Integrated CE Marking and Clinical Affairs Expertise

When needed, MCRA combines its European Regulatory expertise with its industry-leading Clinical Affairs capabilities to provide a seamless, end-to-end solution. We can assess your clinical evidence requirements in detail and, where necessary, generate high-quality clinical data to meet the rigorous demands of the EU MDR—streamlining your pathway to CE marking and market success.
 

Our European Regulatory Services  

•    Device Classification
•    Comprehensive Technical Documentation Support for MDR Compliance
•    Clinical Evaluation
•    Post-Market Surveillance Support
•    Unique Device Identification (UDI) Support
•    Labeling & Instructions for Use (IFU) Support
•    Notified Body (NB) Interaction Support
•    MDR Coding & Technical Documentation Sampling Support
•    Borderline and Overlapping Directive Assessments
•    Annex XVI Device Support – MDR Compliance for Non-Medical Products
•    EUDAMED Registration Support