What is Technical Documentation according to ?
Technical Documentation are the documents required to be prepared to secure CE Certification according to the Regulation (EU) 2017/754 (). The Technical Documentation is provided for review by the Notified Body and/or Authorized Representative, depending on the medical device classification.
How to Prepare the Technical Documentation?
The Technical Documentation includes the following:
- Table of Contents
- Manufacturer’s Declaration of Conformity
- Device description, including type of device, indications for use, materials and performance specifications, including engineering drawings and photographs of the device. Device components and accessories should also be described.
- Methods of manufacture, including flow chart, SOP’s, quality manual, etc.
- Documentation that demonstrates that a Risk Analysis has been conducted for the device in accordance with ISO 14971
- List of Standards
- Results of validation testing, including performance validation tests, sterilization validation, packaging, clinical validation, software validation, etc., as applicable;
- Documentation that demonstrates that the device conforms to harmonized standards, including the following, as applicable:
-Sterilization validation, if applicable
-Biocompatibility of materials, if applicable
-EMC or Electrical and Mechanical Safety testing, if applicable
-Software Validation, if applicable
- Conformance of the device with the General Safety and Performance Requirements (GSPR) as set forth in Annex I of the Directive
- Device labeling material (package labels, instructions for use, etc.)
- Clinical Evaluation Plan and Report (CEP & CER) including results of database searches, copies of relevant literature and results of clinical studies conducted with the device. The CEP and CER should be prepared in compliance with the MEDDEV 2.7/1 and the Regulation (EU) 2017/745 () requirements
- Post-Marketing Clinical Follow-up (PMCF) Plan
- Post-Marketing Clinical Follow-up (PMCF) Report
- Post-Marketing Surveillance (PMS) Plan
- Periodic Safety Update Report (PSUR)
- Summary of Safety and Clinical Performance (SSCP), as applicable
Helping tips when preparing the Technical Documentation:
- Use Guidance documents when preparing the Technical Documentation. Following are several examples:
-For determining medical device classification, use MDCG 2021-24, “Guidance on classification of medical devices” https://health.ec.europa.eu/system/files/2021-10/mdcg_2021-24_en_0.pdf. Other guidance documents may be useful for specific devices, including MDCG 2019-11 for software (https://health.ec.europa.eu/system/files/2020-09/md_mdcg_2019_11_guidance_en_0.pdf) or MDCG 2022-5 for borderline devices (https://health.ec.europa.eu/system/files/2023-06/mdcg_2022-5_en.pdf) .
-When preparing the CER according to the MEDDEV 2.7/1 use the clinical evaluation guidelines – https://ec.europa.eu/docsroom/documents/17522/attachments/1/translations/en/renditions/native and the MDCG 2020-13 guidance for the CER template (https://health.ec.europa.eu/system/files/2020-07/mdcg_clinical_evaluationtemplate_en_0.pdf) .
-Use the PMCF Plan outlined in the MDCG 2020-7 guidance document (https://health.ec.europa.eu/system/files/2020-09/md_mdcg_2020_7_guidance_pmcf_plan_template_en_0.pdf)
How we can help?
A. Stein – Regulatory Affairs Consulting possesses extensive experience preparing Technical Documentation for a diverse range of medical devices — from catheters to MRI systems, including diagnostic, therapeutic, and AI‑driven technologies — that have successfully undergone Notified Body review and achieved CE Certification.
