What is a technical file for a medical device?
A medical device technical file is a concise report created by a manufacturer to explain the performance and safety of a particular item in a clear, well-organized, easily searchable, and unambiguous manner.
In order to prove compliance with the general safety and performance criteria of the legislation, the maker must have – and keep up-to-date – this technical documentation, regardless of a device class, its intended use, design, or even the safety history of the item.
Does the technical file for a medical device require approval?
All devices which are Class I(s), Class I(m), Class I(r), Class IIa, Class IIb, or Class III require approval.
A Notified Body (NB) or a Competent Authority must receive the MDR Technical File Template for assessment and approval.
It ought to be written in English or another official language of an EU member state, and it ought to be made available upon request for the duration of the medical device’s life cycle (five years for low-risk devices and 16 years for high-risk ones), depending on the risk level.
Keep a controlled version of the file on hand at all times since non-EU manufacturers are required to keep the file with an authorised representative in the EU for consultation whenever necessary.
General Class I medical devices do not require approval but must be registered in a member country and a technical file created.
What is contained in a technical file for a medical device?
The following sections should be present in a medical device technical file, according Annex II of the EU MDR 2017/745:
Description and specifications of the device, including all available options and add-ons information on full labelling and packaging, including single-unit sales and transport packaging in the event of particular management circumstances.
- Instructions for usage in each language recognised in the member state where the sale of the medical equipment is anticipated.
- Information on all the locations where design and manufacturing activities are carried out, including design schematics.
- Evidence that all general safety and performance requirements, as well as all applicable harmonised and non-harmonised standards.
- File for benefit-risk evaluation and risk management.
- Reports on product validation and verification, as well as other pertinent documentation.
- Test findings, Biological Evaluation Reports (BER), Clinical Evaluation Reports (CER), and Post-Market Clinical Follow-Up (PMCF) evaluation plans are examples of pre-clinical and clinical data.
- Plan and report for post-market surveillance (PMS).
- Statement of Compliance.
Are there significant changes from the technical file submitted prior to MDR?
With the exception of a PMS plan and a Periodic Safety Update Report (PSUR, for devices greater than Class I, Article 86) or a PMS report (for devices of Class I, Article 85), the total number of documents that must be included in the technical documentation essentially stays the same.
The regulators believe that manufacturers should take the lead during the post-market phase by methodically and actively gathering data from post-market experience with their products in order to update their technical documentation and participate in vigilance and market surveillance activities.
In addition to being used to update technical documentation, such as that relating to risk assessment and clinical evaluation, the pertinent data and information gathered through PMS, as well as the lessons learned from any preventive and/or corrective action implemented, should also serve the purpose of transparency.
The main difference in the technical file, along with the PMS activities and reports, is that a higher standard of technical documentation is now needed, particularly when it comes to clinical data, which must now be reliable enough to properly support any claims.
Additionally, manufacturers must enhance the technical documentation’s clarity and scientific quality in order to maintain their approval to market.
How has the PMS changed under MDR?
The General Safety and Performance Requirements (GSPRs), which must be revised in response to PMS activities, must be documented and shown by medical device manufacturers.
Manufacturers must now upgrade their PMS system proactively in a thorough and methodical manner, according to Article 2 (60), which lists this as one of the MDR’s general requirements.
The standards for PMS should directly correspond to the risk involved with the equipment, enabling the producer to take corrective or preventive action.
This action ought to be reasonable given the type of device and the most recent clinical evaluation.
This means that an effective PMS programme must offer a wide range of real-world experiences through a Post-Market Clinical Follow-Up (PMCF) beyond the limitations of a re-market study.
This strategy should identify issues before they become serious and ensure that corrective action is taken, all while continuously monitoring the long-term effectiveness of the device.
Importantly, each of these steps must go above and beyond mere compliance to add value and foster a strong sense of confidence in the medical device.
Is the new technical file missing any further technical details?
The fundamental Unique Device Identification-Device Identifier (UDI-DI), which must be printed on the device’s label and all higher layers of packaging, must now be included by the makers in the Device description and specification section.
Additionally, there are requirements for the UDI-DI in the case of implantable or reusable surgical equipment so this code number is always readily available.
Manufacturers of Single Use Devices (SUDs) must explicitly state in the risk management paperwork why the device is built in this way; that is, it must be made plain why the item cannot be reprocessed.
Another complication is that manufacturers now have to include information in the technical documentation for all kinds of medical devices, in accordance with Annex II, to describe the stages of design and processes that are applied to their products.
In the past, only Class III devices would make such a request, but now all devices share the same situation.
How is the technical file for a medical device reviewed?
The NB must examine the technical documents in accordance with the device classification for conformity evaluation.
Importantly, the NBs evaluate medical devices using a risk-based approach because the benefits must outweigh the hazards or the risks must be minimised to an acceptable level given the present state of the art and the duration of the certificates that have been awarded.
Each device, whether it is a Class III implanted device, a Class III device, a Class IIb implantable device (with a few exclusions), or a Class IIb active device, is evaluated separately. A minimum of one representative device for each generic group is used to evaluate all other class IIb devices, whereas Class II devices are evaluated for at least one sample device for each device category.
While waiting, Class I items that are marketed as sterile, have a measurement function, or are reusable surgical instruments are only assessed for those particular attributes, such as sterility, measurement, or re-use.
Manufacturers can declare the compliance of their products by providing the EU declaration of conformity referred to in Article 19″3. NBs are not involved in conformity assessment for any other Class I devices.
