Technical Documentation Files Review: Top 5+ Mistakes by Manufacturers

As a regulatory representative for foreign manufacturers in the EU, UK, US and Switzerland, MedEnvoy reviews technical documentation files of the manufacturers that it looks to represent in these markets. During these reviews, we encounter areas in which these files do not comply with the respective regulatory requirements of these markets and provide advice to manufacturers on how they may bring their files into conformity.

Top 5+ mistakes manufacturers make when compiling technical documentation files

While instances of non-compliance are mostly for reviews of self-certified devices, in our experience, they are not exclusive to such devices and might involve devices for which their technical documentation files have already undergone Notified Body review. Below we identify the top mistakes that we see, listed in no particular order.

1. Unique device identification (UDI)

One of the most common issues that we encounter when reviewing technical documentation files, is with the device Basic UDI-DI assignment, particularly for US- or Canadian-based manufacturers or those that have been labeling their devices in accordance with the US FDA UDI requirements for several years and make the incorrect assumption that the Basic UDI-DI and UDI-DI are one and the same. Manufacturers should understand that the Basic UDI-DI is not the UDI-DI of a device.

As the Basic UDI-DI is referenced in relevant certificates and EU declarations of conformity and is among the device description and specification information compiled in the technical documentation file, incorrect assignment of this device identifier impacts several documents. Designated UDI issuing agencies, such as GS1 with its Global Model Number (GMN), have established the tools for their clients to generate Basic UDI-DI for their devices and to understand the corresponding specifications for this identifier. Therefore, manufacturers are encouraged to reach out to their issuing agency to ensure the correct Basic UDI-DI assignment.

Furthermore, if not already familiar, manufacturers should familiarize themselves with the relevant issuing agency standards for UDI-DI allocation (e.g., GS1 Healthcare GTIN Allocation Rules Standard) to ensure that these are correctly configured, and updated as relevant changes are made to device families.

2. Clinical/performance evaluation records

Worthy of an entire article itself (and we recommend readers to read our blog articles on performance evaluation under the IVDR), we frequently come across technical documentation issues with clinical/ performance evaluation, primarily for self-certified devices. Particularly in the case of IVDs, we’ve observed the following situations (by no means an exhaustive list):

• • Lack of a performance evaluation plan or such plans not complying with the minimum content requirements
  • No justification (or appropriate justification) of non-applicability of scientific validity, analytical performance (characteristics), and clinical performance
  • Absence of any systematic scientific literature review or absence of details on the methodology/protocol applied for literature searches/reviews to ensure traceability/repeatability of the searches/reviews performed and/or lack of literature appraisal criteria
  • Absence of PMS / clinical experience data review, where such data is available
  • Lack of analysis demonstrating how the data demonstrates conformity with relevant GSPRs (NOTE: For “legacy devices” continued compliance with the relevant Essential Requirements is still required.)

Manufacturers should ensure that their clinical/performance evaluation records (e.g., plans, reports) are prepared in accordance with the respective regulations and available guidance.

3. Declaration of conformity

Another common mistake we observed when reviewing technical documentations is non-compliant declarations of conformity, specifically non-compliance with Item 6, Annex IV of the MDR/IVDR. Under this item, it is a requirement that the EU declaration of conformity shall contain a “…statement that the device that is covered by the present declaration is in conformity with…any other relevant Union legislation that provides for the issuing of an EU declaration of conformity”.

Therefore, where the characteristics of a device bring it within scope of other Union legislation that provides the issuing of an EU declaration of conformity, a statement regarding conformity with this other Union legislation must be included in the MDR/IVDR declaration of conformity. Such other Union legislation includes the following (as consolidated/amended):

• • Restriction of Hazardous Substances Directive 2011/65/EU (RoHS)
  • Machinery Directive 2006/42/EC
  • Radio Equipment Directive 2014/53/EU (RED)

Manufacturers should assess the characteristics of their devices to determine whether they are within scope of any other Union legislation, take the necessary actions for conformity with the application legislation, and ensure that a consolidated EU declaration of conformity is prepared in accordance with the requirements of the MDR/IVDR. This should be noted by those manufacturers who, under the MDD/IVDD, maintained separate declarations of conformity for each applicable Union legislation that required such a declaration.

Additionally, for those manufacturers that have not applied the UKCA mark to their devices, there is no need to prepare a UK-specific declaration of conformity – this will only be mandatory once this mark is applied. In the case of Switzerland, currently, a declaration of conformity prepared in accordance with the MDR/IVDR, and not the MedDO/IvDO, is appropriate for foreign manufacturers.

4. Labeling/information accompanying the device

While Regulation 2021/2226 covering the requirements for electronic instructions for use (e-IFUs) of medical devices does not apply to IVDs, we have also noted manufacturers that provide e-IFUs for their devices failing to comply with this regulation. In particular, manufacturers failing to have availability on their websites, all previous versions of the e-IFU and their date of publication, and not having a prepared a documented risk assessment specific for the exclusive provision of e-IFUs. Furthermore, manufacturers should be prepared for their authorized representative to verify consistency of e-IFU content between versions available online and those provided as part of the technical documentation file.

Under the Swiss MedDO/IvDO, there remains the option for foreign manufacturers of “legacy devices” to not identify the details of their Swiss Authorized Representative on the device label or IFU. However, in such scenarios, the manufacturer must still provide these details in other documentation accompanying the device. If the manner in which this information will be provided with the device is unclear in the technical documentation file, you should expect your authorized representative to reach out to you to confirm how this information will be provided as well as a sample document for verification purposes. NOTE: Manufactures of self-certified devices /IVDs have different requirements for identifying the CH-REP.

Additionally, Article 16 of the MedDO and Article 15 of the IvDO both establish the conditions that must be fulfilled in order to provide product information in fewer than the three official languages of Switzerland or in English. To avoid questions from your authorized representative, it is recommended that manufacturers clearly justify in their technical documentation files where product information is provided in accordance with these conditions.

5. Insufficient/incomplete device technical documentation file descriptions

We have noted this as more of an issue with IVDs, particularly chemical- or reagent-based IVDs such as buffer solutions, immunochemical reagents (such as lateral flow immunoassays), and mixtures provided as components of IVD kits. The lack of an adequate description of the components of an IVD can have a cascade effect on other components of the technical documentation file, particularly the GSPR Checklist and risk management file. Especially where chemical components are related to the following, they should be appropriate and consistently described across the technical documentation file. For example, descriptions of the following should be clear, where applicable:

• • Biocidal/Microcidal/Fungicidal agents (e.g. sodium azide, whose use/disposal is related to several chemical-related hazards)
  • Tissues, cells and substances of animal, human or microbial origin (e.g., proteins, enzymes, antibodies, antigens, other chemicals etc., utilized in the manufacture of IVDs could be sourced directly from such sources or involve the utilization of such sources in their manufacture)
  • Flammable chemicals (e.g., nitrocellulose in membranes used in lateral flow immunoassays is a known flammable solid and has been responsible for industrial warehouse fires in the past)

6. Non-compliance with Post Market Surveillance Requirements

Building onto our list of the top 5 mistakes made in compiling technical documentation files we are including the responsibility to generate and continually update Post Market Surveillance (PMS) documentation. Regardless of whether developing a new technical documentation file or simply updating an existing technical documentation file for a “legacy device”, manufacturers are obligated to incorporate the MDR/IVDR requirements for PMS int for their technical documentation files. This means that MDR/IVDR-compliant PMS Plans are required to be prepared, along with the release of PMS Reports/Periodic Surveillance Update Reports (PSURs) at a frequency determined by the Class of the device and the manufacturer (for self-certified devices).

We have observed that manufacturers have failed to generate the PMS Plans that are compliant with the MDR/IVDR and/or failed to ensure that PSURs have been released in accordance with the classification of their device/IVD, e.g., annual reporting for Class IIb/III devices and Class C/D IVDs. As almost two years have passed since the MDR date of application, the first PSURs for Class IIb/III devices should have already been repaired, and the first PSURs for Class IIa devices should be in development. Manufacturers of Class C/D IVDs should be developing the first PSURs under the IVDR, given that it has nearly been one year since the IVDR date of application. Ultimately, there is no acceptable reason to justify non-compliance with the MDR/IVDR PMS requirements.

Consult with MedEnvoy to eliminate technical documentation file mistakes

The above are just a few examples of the types of mistakes that we often see in technical documentation file, and for which we can also provide consulting support for a resolution.

Reach out to MedEnvoy for additional questions when preparing technical documentation files

If you have any questions regarding technical documentation file compilation, would like a gap analysis of your documentation, or require relevant training/consulting services, get in touch.