MDR Technical Documentation

MDR Technical Documentation, so-called Technical File for Medical Device, is a comprehensive file covering complete information to demonstrate the device’s safety and performance against the manufacturers 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 information in the correct way; 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.
    • 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 labelling 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 regulation, 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 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.

FAQ’s

You may be confused; even though you appoint a consultant, who is doing what? How to do it? What should we do? Please read the below table for your information.

SL NO DESCRIPTION OF ACTIVITY CLIENT CONSULTANT
01 Description of the Device As to be provided as per consultant instruction
02 Intended use of the device To be provided as per consultant instruction
03 Device models & Specification To be provided as per consultant instruction
04 Mechanism of action To be provided as per consultant instruction
05 Classification and justification of Medical Device Consultant will provide
06 List of Applicable Directives Consultant will provide
07 List of Applicable MDD Guidelines followed Consultant will provide
08 List of Applicable Harmonized Standards The client has to provide after taking advice from a consultant.
09 List of Applicable Non-Harmonized Standards The client has to provide after taking advice from a consultant.
10 Declaration of Conformity Consultant will Draft
11 Use of Animal Origin products Consultant will provide
12 Use of Blood or Blood Components Consultant will provide
13 Integration of a Medicinal Product into the Device Consultant will provide
14 Product Design documents the client has to provide as per ISO 13485 The consultant will review and guide wherever necessary
15 Connection to other Devices The client has to provide
16 Phthalates Free Declaration Consultant will provide
17 EC Representative The client has to organize the consultant will draft if required.
18 Essential Requirement Checklist Consultant will provide
19 Risk Analysis As per ISO 13485 and EN ISO, 14971:2007 Client has to provide The consultant will review, modify according to NB
requirements
20 Clinical Evaluation Consultant will provide
21 Description of Manufacturing The client has to provide
22 Critical process & MSDS The client has to provide The consultant will guide and review the documents
23 Description About critical suppliers and their quality certificates The client has to provide
24 Environmental controls To be provided as per consultant instruction The consultant will guide and review the documents
25 pre-clinical testing To be provided as per consultant instruction The consultant will guide and review the documents
26 In-House test reports To be provided as per consultant instruction
27 Bill of materials The client has to provide
28 Device shelf life The client has to conduct the study report Consultants will provide guidance
29 Biocompatibility The client has to organize the report Standard Identification by consultant
30 Electrical safety The client has to organize the report Standard Identification by consultant
31 Product Specific Standards The client has to provide
32 Usability To be provided as per consultant instruction The consultant will guide and review the documents
33 Software validation To be provided as per consultant instruction
34 Sterilization To be provided as per consultant instruction The consultant will guide and review the documents
      35 Quality Controls The client has to provide documents as per consultant instructions.
36 Device Labelling The client has to provide documents as per consultant instructions.
37 Device Packing The client has to provide documents as per consultant instructions.
38 Storage and Transportation The client has to provide documents as per consultant instructions.
39 Packaging validation The client has to provide documents as per consultant instructions The consultant will guide and review the documents
40 The lifetime of the device The client has to provide documents as per consultant instructions The consultant will guide and review the documents
41 Post Manufacturing Activities The consultant will prepare related procedures &relevant templets as per ISO 13485

Preparing MDR 2017/745 Technical File is a tedious process. Proper understanding, Technical Knowledge & team efforts, along with an experienced team of consultants, are highly essential for the timely completion of MDR Technical Documentation / Technical File. The below table explains the technical file content only for study and information only.

1.0 TABLE OF CONTENTS
2.0 NATURE OF AMENDMENT
2.1 Issue Register
2.2 Revision Register
3.0 WARNING
4.0 TECHNICAL FILE
5.0 PURPOSE
6.0 SCOPE
7.0 COMPANY PROFILE
8.0 DEFINITION OF TERMS
8.1 Technical file
8.2 Design Dossier
9.0 MEDICAL DEVICE INFORMATION
9.1 Device models and Variants
9.2 Description of the Device
9.3 Intended use of the Device
9.4 Mechanism of Action
10.0 DESIGN DOSSIER
10.1 Device Drawings
10.2 Device Specifications
10.3 Design Approvals
10.4 Design Transfer
10.5 Bill of material
11.0 MDD COMPLIANCE
11.1 Classification and justification
11.2 List of Applicable Directives
11.3 List of Applicable MDD Guidelines followed
11.4 List of Applicable Harmonized Standards
11.5 List of Applicable Non-Harmonized Standards
11.6 Use of Medical Substance
11.7 Use of Animal Origin products
11.8 Use of Blood or Blood Components
11.9 Integration of a Medicinal Product into the Device
11.10 Connection to other Devices
11.11 Declaration of Conformity
11.12 EC Representative
11.13 Essential Requirement Check List
11.14 Risk Analysis
11.15 Post Market Surveillance (PMS)
11.16 Post Market Clinical Follow-up (PMCF)
11.17 Clinical Evaluation
12.0 MANUFACTURING PROCESS
12.1 Description of Manufacturing
12.2 Description About critical process
12.3 Environmental controls
12.4 Critical suppliers
12.5 Critical Process(validations)
12.6 In-house Testing
12.7 Pre- Clinical Testing
12.8 Biocompatibility
12.9 Electrical Safety
12.10 Usability
12.11 Sterilization
12.12 Software Validation
13.0 PRODUCT PACKING AND TRANSPORTATION
13.1 Device Labeling
13.2 Device Packing
13.3 Storage and Transportation
13.4 Packaging Validation
13.5 Transportation Validation
13.6 Device shelf-life / Life Time

Request for proposal
Enquire Now