Regulatory documents require a strong scientific and technical expertise to correctly summarize the necessary data collected in the course of developing a medical device product.
A CE Marking Technical File or Design Dossier (Class III) is a comprehensive description of the device which is intended to demonstrate compliance with European requirements. Compiling a technical file or design dossier is a critical step in Europe’s CE Marking Process and a requirement for compliance with the Medical Devices Directive 93/42/EEC and the Medical Devices Regulation MDR 2017/745.
The technical documentation includes detailed information about the design, function, composition, use, claims, and clinical evaluation of the medical device. A technical file is required for all classes of devices (Class I, IIa, IIb, and III) but no two technical files are the same because the type of device dictates the information included therein. The technical documentation must be reviewed by a Notified Body (except for Class I device that is not provided sterile and does not have a measuring function). Understanding how to assemble this information and present it for review by Notified Bodies is essential. We can support you in this process by:
- Reviewing all existing documentation in support of meeting the applicable Essential Requirements / GSPRs
- Evaluate and identify gaps or deficiencies in your documentation.
- Compile your EU Technical File or Design Dossier, with internal peer review.
- Determine applicable testing requirements and standards for your device.
- Review clinical data, compile a Clinical Evaluation Report (CER), and facilitate a Risk Assessment as necessary.
- Review proposed labeling and Instructions for Use.
AKRN can provide state-of-the-art literature research on emerging technologies, MedTech innovations, and medical trends that can provide background summaries, reports, and manuscripts in the medical and scientific setting.
AKRN works with manufacturers preparing the following key reports.
- Clinical Investigational Plan (CIP) according to ISO14155:2019 and MDR 2017/745
- Clinical Study Report (CSR)
- Clinical Literature Research and Report according to MEDDEV 2.7/1 Rev 4
- Clinical Evaluation Report (CER) according to MEDDEV 2.7/1 Rev 4
- Summary of Safety and Clinical Performance (SSCP) according to MDR 2017/745
- Post Market Surveillance (PMS) Plan
- Post Market Clinical Follow Up (PMCF) Protocol
- Investigator Brochure (IB) Development
A key task of the Medical Writing service is to be sure that all deliverables are in accordance with regulations, standards, and guidelines. The regulatory documents we prepare meet ISO 14155 and GCPs guidelines, MEDDEV 2.7/1 Rev 4 and MDR 2017/745. Our team has a comprehensive understanding of the level of evidence required to meet the regulatory demands.