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.
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- Review existing documentation in support of meeting the applicable MDR Essential Requirements.
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- Study the device, Identify and evaluate gaps or deficiencies in your new EU MDR.
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- Determine applicable testing requirements and standards for your device after a Risk Analysis.
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- Preparation of Post Market Surveillance Report (PMS) and derive the conclusion of CER.
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- Preparation of Post Market Clinical Follow-Up Report (PMCF) and derive the conclusion of CER.
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- Review your specimen labeling and Instructions for Use (IFU)and User Manual.
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- 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
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 |
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