The need for a detailed Technical File, i.e. the complete technical documentation needed to demonstrate that a particular Medical Device, or In-Vitro Diagnostic Medical Device, conforms to the regulations and is safe to place on the market, is essential for all devices, even those that are for low-risk.
As part of their key obligations under the EU Regulations for medical devices and IVDs, manufacturers are required to draw up technical documentation in accordance with Annexes II and III of the EU Medical Device Regulation 2017/745 (MDR) and the EU IVD Regulation 2017/746 (2017/746), as applicable.
A technical file built in accordance with these Regulations will typically consist of the following:
- Device Description and Specification.
- Information provided by the Manufacturer (IFU, Labels, Marketing Material, Implant Card).
- Design and Manufacturing Information.
- General Safety and Performance Requirements.
- Risk Management (ISO 14971), including:
- Risk Management Plan.
- Risk Identification and Assessment.
- Risk Management Report.
- Verification and Validation, including:
- Pre-clinical testing, including where relevant:
- Biological Evaluation Plan / Report (ISO 10993).
- Electrical and EMC Considerations (IEC 60601 Series).
- Software Validation (EN 62304).
- Usability (IEC 62366).
- Sterilisation Validation.
- Clinical Data: Clinical Evaluation Plan and Report (CEP/CER), or Performance Evaluation Plan and Report (PEP/PER) for the MDR and IVDR respectively.
- Pre-clinical testing, including where relevant:
- Post-Market Surveillance (PMS), including:
- PMS Plan.
- PMS Report / Periodic Safety Update Report (PSUR).
- Post-Market Clinical Follow-up (PMCF) Plan and Report.
- Declaration of Conformity.
- Summary of Safety and Clinical Performance (where applicable).
This should NOT be considered a complete list of required documents, since the documentation required to demonstrate conformity with the applicable Regulation will greatly depend on the device and its intended purpose.
The extent of work involved and information available within the technical file will vary depending on the overall risk of the device, the device type, its intended purpose and indications, target patient/user populations, as well as its sterility, activity, invasiveness and whether it contains medicinal products, tissues, and CMR and endocrine-disrupting substances.
When compiling technical documentation, we take into account our extensive experience with Notified Body audits and expectations, as well as state of the art EU and International guidance, including applicable MEDDEV and MDCG Guidance, IMDRF, and US FDA-issued guidance to mention a few.
All of our consultancy projects will typically begin with a conference call to discuss the device and the activities involved. Depending on the information already available, we will then discuss the information and documentation which may be required to build the technical file.
For a free consultation, please contact us.
