Medical Device Technical File Construction

Is your medical device technical file structure easy to follow?

Is your medical device technical file presented in a clear, organised, readily searchable and unambiguous manner?

Annex II and  III under the MDR 2017/745 and IVDR 2017/746 stipulate that the technical documentation should be organised. It also details the required content with specific information:

• Device description and specification, including variants and accessories
• Information to be supplied by the manufacturer
• Design and manufacturing information
• General safety and performance requirements (GSPRs)
• Benefit-risk analysis and risk management
• Product verification and validation data
• Post-market surveillance.

At MedDev Regulatory (MDR) Consultancy, we regularly encounter medical device technical files that have not necessarily been set out in the most logical manner. It is always best to get a second opinion, as a layout that works for you does not always work for everyone else, including your Notified Body reviewer.

Seeking a second opinion can provide valuable insights and improve the overall quality of your technical file. A well-presented, descriptive medical device technical file will aid in a quicker and more efficient audit review and reduce the number of unnecessary questions asked by your Notified Body.

MedDev Regulatory (MDR) Consulting are experts in medical device technical files, and our consultancy services are tailored to meet your needs at competitive and cost-effective rates.