CE Marking for EU MDR and EU IVDR

CE Marking services

Achieving CE marking under the EU Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) is essential for marketing medical devices and IVDs in the European Union. The process is complex, requiring thorough documentation, clinical evidence, and engagement with Notified Bodies.

Our consultants guide you through the CE marking process, ensuring compliance while minimising delays and regulatory risks.

Contact us

Navigating CE Marking compliance for medical devices & IVDs

The EU MDR (2017/745) and IVDR (2017/746) have introduced stricter requirements for medical device and IVD manufacturers, including enhanced clinical evaluation, post-market surveillance, and supply chain oversight. Companies must meet these evolving demands while ensuring product safety and effectiveness.

Our experienced consultants help you:

  • Determine device classification and select the appropriate CE marking pathway and conformity assessment route.
  • Develop comprehensive technical documentation aligned with MDR/IVDR requirements.
  • Prepare for Notified Body assessments and regulatory submissions.
  • Implement effective UDI strategy and EUDAMED registration
  • Implement post-market surveillance and risk management strategies.
  • Ensure a smooth transition from MDD/IVDD to MDR/IVDR for legacy products.

Why use our support for your CE Marking process?

With our expert regulatory support, your company can achieve CE marking efficiently, ensuring continued market access in the EU while meeting the highest standards of safety and performance. Successfully achieving CE marking requires in-depth regulatory expertise and meticulous preparation. Our services include:

  • Regulatory Classification & Conformity Assessment Strategy – Identifying the correct classification and approval pathway under MDR/IVDR.
  • Technical Documentation Development – Preparing compliant technical files, including risk management (ISO 14971), clinical evaluation (MDR), and performance evaluation (IVDR).
  • Clinical Evaluation & Performance Evaluation Support– Ensuring sufficient clinical evidence for MDR and IVDR.
  • Notified Body Interaction & Submission Support – Guiding companies through the review process and responding to regulatory queries.
  • EUDAMED & UDI Support – Support with implementing UDI requirements and registration with EUDAMED
  • Post-Market Surveillance & Vigilance Compliance – Support with PMS, vigilance, and periodic safety update reports (PSUR) requirements.
  • Gap Assessments & Transition Planning – Helping companies move from MDD/IVDD to MDR/IVDR with minimal disruption.
  • PRRC Support – Assisting non-EU manufacturers with compliance obligations.
Your contact person
Portrait of Nelly Fransen Arex Advisor

Nelly Fransén

www.arexadvisor.com

Arex Advisor AB

  • Sveavägen 9,
  • 111 57 Stockholm
  • Sweden

Contact us

Linkedin

Staffan Thunell

Founding partner

BSc Economics and BA

Staffan has a long background in entrepreneurship within the life science industry. He has 20+ years experience from posit­ions as Founder, Chair­man, CEO and CFO within medical affairs consulting and small pharma. Previously Staffan worked in executive positions in big pharma and specialty pharma companies.