MDR Technical Documentation

MDR Technical Documentation

MDR Technical Documentation, the so-called Technical File for Medical Device, is a comprehensive file covering complete information to demonstrate the device’s safety and performance against the manufacturer’s claimed intended use. The information given in the Technical Files is structured as per MDR and IVDR requirements suitably to address General Safety and Performance Requirements (GSPR).

The notified body will audit technical files annually to assess compliance with general safety and performance requirements. The Technical File should be developed for all types of device risk classes. (I, Is, Im, Ir, IIa, IIb, III).

The latest version of Technical Files must be retained either in electronic or hardcopy form at manufacturer premises or authorized representative premise for potential request from an EU competent authority or from Notified Body. During the initial phase of the CE Marking application, complete technical documentation must submit to the notified body. After closing all review comments and updating the technical file, the notified body issues CE Certificate.

All manufacturers need to update their technical documentation as all are aware of the change in regulation from MDD / IVD to MDR / IVDR. We are medical device regulatory consultants who provide MDR / IVDR remediation services. MedDeviceCorp team has gained sufficient knowledge in MDR/IVDR via training, internal debate, conferences, workshops, and live-up-gradation services.

MDR Technical Documentation Requirements

According to the new Medical Device Regulation, annex II identifies forty-seven specific requirements about the primary file technical documentation content and fifteen additional requirements from Annex III on Post Market Surveillance.

Article 10 describes the obligation of manufacturers what is needed and why it is needed in the Medical Device Regulation Technical Documentation. Article 15 insists on an experienced regulatory person and his role in updating the Technical Documentation anytime for Notified Body assessment. While preparing a tech file, you should have sound knowledge technically to present the information correctly; some of the core areas are the following.

• • Review existing documentation in support of meeting the applicable MDR Essential Requirements.

• • Study the device, Identify and evaluate gaps or deficiencies in your new EU MDR.

• • Determine applicable testing requirements and standards for your device after a Risk Analysis.

• • Organize Clinical Evidence in the form of a Clinical Evaluation Report (CER).

• • Preparation of Post Market Surveillance Report (PMS) and derive the conclusion of CER.

• • Preparation of Post Market Clinical Follow-Up Report (PMCF) and derive the conclusion of CER.

• • Review your specimen labeling and Instructions for Use (IFU)and User Manual.

• • Compile Pre-Clinical Verification and Validation documentation.

The MDD’s Design Dossier concept has been removed from the new EU MDR. 

Consultants Role in Technical Documentation

We can deliver structured solutions for developing high-quality Technical Documentation for any risk class, starting from drafting the File, reviewing and modifying the contents, supporting filling the Gaps, submitting to Notified Body of your choice, and coordinating with Notified bodies till documentation is approved.

If you are finding ways to update a legacy medical device technical file to meet new medical device regulations, we at MedDeviceCorp help with Medical Device Technical File remediation service. After a thorough understanding of your subject device, we start our guidance and preparation to identify disparities between your medical device and the present technical file/requirements. Unlike others, we do not allow the client team to work on the technical file till the successful completion of the CE Certification project.

Quick Checklist for MDR Technical Documentation

◊   Designate PRRC to be in charge of regulatory compliance and ensuring that technical documentation is constantly up to date.

◊   Foreign manufacturers ensure that a controlled copy of the MDR technical documentation is always available to the EU /EC representative.

◊   Assign a UDI to the medical device by MDR Article 27 and complete all required labeling using the UDI.

◊   Check that the technical documentation contains all of the required information, as described in Annexes II and III of the MDR.

◊   Ascertain that the medical device meets the GSPR requirements outlined in Annex I of the MDR and that the technical documentation is.

◊   Necessary effort to create a strong clinical evaluation to comply with the MDR requirements for clinical data to get a robust substantiation of any claim made for devices that are currently on the market. Use PMS data as input.

FAQ’s