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What is Technical File?

The technical files for medical devices refer to all the documents that a medical device manufacturer has to submit to demonstrate that the product conforms to the applicable and current medical device regulations. A MDR consultant can help navigate this complex process, ensuring the technical file is complete and in compliance with the necessary standards.

Technical files for medical devices shall include, e.g. a detailed description of the device and specification, reference to the previous and similar generation of the device, design information, pre-clinical testing information, clinical evaluation, and risk management of the medical device. A CE technical file is an essential part of this documentation, especially when seeking CE marking approval.

Technical files for medical devices shall be prepared by the medical device manufacturer, and the information in the technical file or CE marking technical file must be presented in a clear, organized, readily searchable, and unambiguous manner to demonstrate the safety and performance of the medical device in question. Engaging a MDR consultant ensures that all documentation is properly structured and meets the regulatory requirements.

Why Is Medical Device Technical Documentation Important?

Medical device technical documentation is crucial to ensure compliance with regulatory requirements like the EU MDR 2017/745. It provides comprehensive evidence of a device’s safety, performance, and effectiveness, which is essential for obtaining CE marking. A well-prepared CE technical file is critical for manufacturers seeking to demonstrate their product’s conformity to relevant standards. For medical devices to be marketed within the EU, they must undergo rigorous evaluation and approval by a notified body, which reviews the CE marking technical file. Engaging an experienced MDR consultant helps ensure that all documentation is complete, accurate, and up to date, simplifying the regulatory process and improving market access. A robust technical file also supports ongoing post-market surveillance and facilitates any required updates.

Medical Device Technical File (MDR)

If you’re looking to prepare a medical device technical file as per the requirements of MDR 2017/745, you might have many questions, such as:

What should be covered in the medical device technical file?
Which Annex of MDR 745/2017 should be referenced for the preparation of the MDR technical documentation?
Who will review and approve the MDR technical file?

At Maven Profcon Services LLP, we have all the answers for you.

The medical device technical file must be prepared in compliance with the requirements outlined in Annex II and Annex III of MDR 2017/745.

This MDR technical documentation must be submitted to a notified body or competent authority for review and approval to obtain CE certification. It should be created in English or the official language of an EU member state.

Under the MDR, the manufacturer is required to store the technical file for 10 years (or 15 years for implantable devices) after the last device has been placed on the market. For non-EU manufacturers, the documents should also be available with the Authorized Representative.

It is the manufacturer’s responsibility to keep the MDR technical file checklist updated and in compliance with the general safety and performance requirements outlined in Annex I, Annex II, and Annex III of MDR 2017/745.

Using the right MDR template ensures that your technical file is comprehensive and in full compliance with regulatory standards.

Technical File content

Sr. No.	Section	Description
Section 1 General and Administrative Information.
1.	1.0	Table of Content
2.	1.1	Technical file approval team
3.	1.2	General information for the Technical file structure including purpose, scope
4.	1.3	Company Profile
5.	1.3.1	Legal Name & Address of the Manufacture
6.	1.4	Authorized Representative name, address and contact details
7.	1.5	Notified Body Name, Number and Address
Section 2 Technical Documentation
8.	2.1	Device Description And Specification, Including Variants And Accessories
9.	2.1.1	Device description and specification Product name or trade name General Description of Device Intended Purpose Indication of use
10.	2.1.1.1
11.
12.
13.
14.	2.1.1.2	Basic UDI-DI
15.	2.1.1.3	Intended patient populations, including details of if applicable; Medical Condition to be diagnostic, treatment, or monitoring Patient selection criteria Indication Contraindications Warning

16.	2.1.1.4	Principle of operation including mode of action
17.	2.1.1.5	Rational for considering the product as medical device
18.	2.1.1.6	Device Classification and Justification for the classification rule as per Annex VIII
19.	2.1.1.7	Explanation of Novel Features
20.	2.1.1.8	Description of Accessories of device
21.	2.1.1.9	A Description of various configurations/variants
22.	2.1.1.10	General description of key components for including software where appropriate required add photograph, drawing and Diagram
23.	2.1.1.11	Description of Raw Materials
24.	2.1.1.12	Technical Specification like feature, dimension
25.	2.2	Reference of Previous and Similar Generations of the device
26.	2.3	Information Supplied by the Manufacturer
27.	2.3.1	Labels: Primary Label, Secondary label and Tertiary label Provide the primary, secondary, and tertiary labels as required. If the device is sold in a country that requires specific language labels, ensure labels are available in the appropriate language, in line with CE marking technical file requirements.
28.	2.3.2	Instruction for use (IFU) If you are selling device require specific county language then IFU should be available on that language
29.	2.4	Design and Manufacturing Information
30.	2.4.1	Product design File
31.	2.4.2	Manufacturing process and their process validations
32.	2.4.3	Final Product Specification & Testing
33.	2.4.4	Manufacturing Environment Control
34.	2.4.5	Identified the sites including supplier & subcontractors, where design activates are performed
35.	2.5	General Safety & Performance Requirements (GSPR)
36.	2.5.1	List of Applicable Harmonized Standards, Common Specification (CS), Non-harmonized standards, applicable guidelines
37.	2.5.2	General Safety & Performance Requirements (GSPR)
38.	2.5.3	Declaration of Conformity
39.	2.6	Benefit and Risk Analysis & Risk Management
40.	2.7	Product Verification and Validation
41.	2.8	Pre-clinical and Clinical Data
42.	2.8.1	Pre-clinical and Clinical summary report
43.	2.8.2	Biocompatibility of the device
44.	2.8.3	Electrical Safety and compatibility
45.	2.8.4	Physical, Chemical & Microbiological Compatibility
46.	2.8.5	Software Verification and Validation
47.	2.8.6	Stability or self-life
48.	2.8.7	Sterilization
49.	2.8.8	Performance & Safety
50.	2.8.9	Clinical Evaluation Report
51.	2.8.10	Post Marketing Activities PMCF Plan & Report PSUR Report PMS Plan & Report Tread Reports
52.	2.8.11	Packaging & Transportation information
53.	2.9	Additional Information is required in specific case:
54.	2.9.1	When device incorporate a substance consider separately as medicine
55.	2.9.2	Device is manufactured by using tissue or cells of human or animal origin
56.	2.9.3	Device that are composed of substance or combination of substance
57.	2.9.4	CMR or Endocrine-Disrupting Substance
58.	2.10	Detail of Device with measuring function
59.	2.11	Details of the device to be connected to other device to achieved its intended purpose
60.	2.12	Revision History
61.	2.13	Conclusion & Approval

Consultant of Technical Files for Medical Devices

Our regulatory consultants at Maven, experienced in various fields of Medical Device Regulations, are well-versed in handling technical documentation, including clinical evaluation, Benefit-Risk Analysis, validations, design and development files, shelf life stability study, usability engineering files, safety and biological evaluation, and chemical characteristics evaluation.

Our MDR consultants assist you in identifying requirements as per EU MDR, selecting the appropriate CE assessment route based on the device class, supporting clinical evaluation, and ensuring compliance with post-marketing activities, risk analysis, and quality management implementation.

Maven, as an emerging medical device regulatory consultancy, helps establish your products in multiple countries with the support of our skilled regulatory consultants. We take care of the following activities:

Gap analysis of the Medical Device Technical File according to EU-MDR requirements.
Identification and classification of the medical device as per EU MDR.
Assistance in selecting the conformity assessment route and Notified Body.
Preparation and review of the CE technical file in line with EU MDR.
Ongoing maintenance and updates of the technical file post-certification.

For more details please refer our blog: Technical Documentation In EU MDR 745/2017

This ensures your products remain compliant, reducing risks while facilitating a smoother market entry with the proper MDR template in place.