Europe Regulatory ServicesMEDREG provide expert services for technical documentation grouping under EU Regulations, helping manufacturers systematically categorise medical devices based on intended purpose, design, materials, technology, manufacturing processes, classification, and risk profiles.
Our services include defining appropriate device groups, preparing separate technical files for distinct device groups, establishing representative-device sampling strategies, and documenting technical justifications to support conformity assessment. We ensure that technical documentation is systematically structured, device-specific, and aligned with applicable regulatory requirements, facilitating efficient Notified Body review and CE marking.
- Identification of Device Groups: Devices are identified and grouped based on their intended purpose, classification, design characteristics, technology, materials, manufacturing processes, and risk profiles.
- Assessment of Technical Similarities: The technical characteristics of each device are evaluated to determine whether devices can be grouped within a common technical file. Devices with distinct intended purposes, designs, materials, or technological characteristics are assigned separate technical files, as appropriate.
- Preparation of Separate Technical Files: Separate technical files are maintained for different device groups based on their specific technical and regulatory requirements. Each technical file contains device-specific documentation, including the device description, risk management documentation, GSPR checklist, verification and validation reports, clinical evaluation, and applicable post-market surveillance documentation.
- Selection of Representative Devices for Sampling: Where sampling is applicable, representative devices are selected based on design variations, technical characteristics, risk classification, and worst-case considerations. The selection rationale must demonstrate that the sampled devices adequately represent the relevant characteristics of the device group.
- Review of Technical Documentation: The technical documentation is reviewed to verify that the selected grouping and sampling approach adequately demonstrates conformity with the applicable General Safety and Performance Requirements (GSPRs) under Regulation (EU) 2017/745.
