A complete scope of regulatory services for Medical Devices

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 complexity of relevant regulation is determined by the classification of the device according to invasiveness and risk.

For your device application with the EMA, a technical file or design dossier has to be submitted. This file contains details about the device specifications, design and manufacturing information, labeling, general safety and performance requirements, benefit-risk and risk management plans, clinical evaluation reports, post-market surveillance strategy, and the quality management system.

The technical file or design dossier and the quality management system are assessed and audited by Notified Bodies (NBs), which are third-party companies designated by the Competent Authorities in the EU. If your device meets the MDR/IVDR standards, a notified body will issue CE marking. After market approval, NBs will perform annual audits to confirm continued compliance to ISO 13485:2016 Medical Devices standards for the quality management system and compliance to EU regulations at least every five years.

In the EU, a medical device manufacturer needs to have a Person Responsible for Regulatory Compliance (PRRC) or an Authorized Representative. Biomapas also offers an Authorized Representative service.

Medical Device Regulation

The MDR and IVDR have come 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 operate in the complex field of scientific and regulatory requirements and provide high-quality services for your products’ clinical development from design, certification, and post-approval needs. We provide you with focus and help you set realistic milestones, identify and mitigate risks, and align your goals with Notified Bodies’ requirements in the EU and EAEU.

Our Regulatory Affairs services related to medical devices include:

• Guidance on medical device classification;
• Consulting on the European Medical Devices Directives;
• CE Marking Consulting for Medical Devices and IVDs;
• Technical File Preparation for Medical Devices and IVDs;
• Interaction with and documentation preparation for Competent Authorities;
• Authorized Representative service in EAEU.
• Biomapas also offers Clinical Evaluation and Materiovigilance services on Medical Devices.