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Medical Device & IVD Services in the EU

Medical Device & IVD Experts.

To take your product from idea to CE.

Biomapas’ local experts can provide you with regulatory Medical Device Services in the EU to take you from idea to CE marking. Compliance with your medical device or in-vitro diagnostic device is highly dependent on the EU’s Medical Device Regulation (MDR) and the In Vitro Diagnostic Device Regulation (IVDR), officially called Regulation (EU) 2017/745&746. The device’s classification determines the complexity of relevant regulation according to invasiveness and risk. In addition, you must submit a technical file or design dossier for your device application with the EMA. This file contains details about the device specifications, design and manufacturing information, labelling, general safety and performance requirements, benefit-risk and risk management plans, clinical evaluation reports, post-market surveillance strategy, and the quality management system.

 

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Take your Medical Device or IVD from idea to CE

Expand your reach across Europe by working with our local Medical Device & IVD experts.

Complete Medical Device Development and Approval in the EU

The technical file or design dossier and the quality management system are assessed and audited by Notified Bodies for CE marking. After market approval, Notified Bodies will perform annual audits to confirm continued compliance to ISO 13485:2016 Medical Devices standards for the quality management system and compliance with EU regulations at least every five years. In the EU, a medical device manufacturer must have a Person Responsible for Regulatory Compliance (PRRC) or an Authorized Representative. Biomapas’ scope of regulatory Medical Device Services in the EU encompasses the full product lifecycle.

MDR & IVDR

The MDR and IVDR came into effect in 2021. Still, future aspects such as the Unique Device Identification (UDI) system and the adaptation of the EUDAMED database require up-to-date regulatory knowledge and anticipation for future changes in the manufacturing process and documentation. We help navigate the complex scientific and regulatory field and provide solutions from design, and certification, to post-approval needs. We help you focus and set realistic milestones, identify and mitigate risks, and align your goals with Notified Bodies’ requirements in the EU.

Regulatory Medical Device Services in the EU:

  • Guidance on medical device classification;
  • Consulting on the European MDR;
  • CE Marking Consulting for Medical Devices and IVDs;
  • Technical File Preparation for Medical Devices and IVDs;
  • Interaction with and documentation preparation for Competent Authorities;
  • EUDAMED registration service;
  • Post-Market Surveillance (PMS) service;
  • Clinical Evaluation and Materiovigilance services for Medical Devices.

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Olga Bernardova

Olga Bernardova

Head of Global Regulatory Affairs

Olga Bernardova has over a decade of regulatory affairs experience. As a proven leader in regulatory affairs, Olga Bernardova has in-depth experience at regional and international level regulatory activities guidance and implementation.