CE Marking & UKCA Marking for Medical Devices

What is CE Marking for Medical Devices?

CE Marking is a mandatory requirement for medical devices to be sold in the European Union. It signifies that the device meets the safety and performance requirements set out in the relevant EU legislation, such as the MDR or IVDR. CE Marking is the manufacturer’s declaration that the product satisfies the essential requirements and has undergone the appropriate conformity assessment.

Our team assists you in the CE Marking process, from technical documentation and clinical evaluation to working with Notified Bodies and labeling requirements, helping you achieve compliance and market access in the EU.

CE Marking for Medical Devices (EU)

The CE Mark is required for medical devices to be sold within the European Union (EU) and European Economic Area (EEA). It indicates that the device meets the requirements of the Medical Device Regulation (MDR) (EU 2017/745) or In Vitro Diagnostic Regulation (IVDR) (EU 2017/746), ensuring it is safe, effective, and compliant with EU standards.

Key Steps to Achieve CE Marking:

  1. Device Classification: We help you determine the correct classification of your medical device (Class I, IIa, IIb, or III) to establish the appropriate route for CE Marking.
  2. Risk Management: We assist in implementing a robust ISO 14971 risk management system, ensuring comprehensive risk identification, assessment, and mitigation.
  3. Preparation of Technical Documentation: We support the creation of a detailed Technical File or Design Dossier, ensuring compliance with the MDR.
  4. Clinical Evaluation: We help conduct a Clinical Evaluation that supports your device’s safety and performance claims through clinical trials or data review.
  5. Conformity Assessment: We assist in navigating the conformity assessment process, which may involve engaging with a Notified Body for higher-risk devices.
  6. Declaration of Conformity: We help you draft the Declaration of Conformity, certifying compliance with EU regulatory requirements.
  7. Post-Market Surveillance: We support implementation of a PMS system, including vigilance reporting and periodic safety updates.

UKCA Marking for Medical Devices (UK)

Following Brexit, the UK Conformity Assessed (UKCA) mark is now required for medical devices placed on the market in Great Britain. It ensures compliance with UK Medical Device Regulations 2002 (as amended).

Key Steps to Achieve UKCA Marking:

  1. Device Classification: We guide you in determining the correct classification under UK regulations.
  2. Technical Documentation: We support preparation of compliant Technical Documentation for UKCA certification.
  3. Approved Body Engagement: For higher-risk devices, we facilitate the engagement process with a UK Approved Body.
  4. Clinical Evaluation: We ensure compliance with UK clinical evidence requirements, supporting performance validation.
  5. Declaration of Conformity: We assist in drafting the UKCA Declaration of Conformity for legal market access.
  6. Post-Market Surveillance: We help maintain compliance with vigilance, adverse event reporting, and ongoing safety updates.

Why Choose Us for CE & UKCA Marking?

  • Expert Regulatory Guidance: We specialize in EU MDR and UK Medical Device Regulations, ensuring full compliance.
  • End-to-End Support: We provide full support from classification to final submission for both CE and UKCA marking.
  • Global Market Access: Our guidance ensures compliance with both EU and UK regulations, expanding market opportunities.
  • Compliance Assurance: We ensure comprehensive documentation to avoid delays or regulatory setbacks.
  • Post-Market Monitoring: We help establish surveillance systems to ensure ongoing product safety and performance.

Let us simplify your path to CE and UKCA Marking, ensuring that your medical device meets all regulatory requirements for market access. With our expertise, you can confidently launch your device in both the EU and UK markets.