Technical Documentation (TD) is a fundamental element for the marketing of medical devices (MD) and in vitro diagnostic devices (IVD) in Europe, as it encompasses all the necessary information to demonstrate the product’s compliance with safety and performance requirements as stipulated by European Regulations 2017/745 (MDR) and 2017/746 (IVDR).
In this article, we will delve into the details of its preparation, comparing procedural systems and kits of MD with IVD kits.
Definitions
Procedural System or Kit according to MDR:
- “Procedural Kit”: A combination of products packaged together and placed on the market for use in a specific medical purpose.
- “System”: A combination of products, packaged together or not, intended to be interconnected or combined to achieve a specific medical purpose.
IVD Kit according to IVDR: A set of reagents, calibrators, controls, and/or other materials intended to be used together to perform a specific analysis or other diagnostic process.
Important Differences
A procedural system or kit, as long as its intended use is medical, may contain other types of products covered by different regulations, and NOT only medical devices.
Moreover, procedural systems and kits—except in certain specific cases—are not considered standalone medical devices: they are therefore not marked with the CE mark and do not have a risk class assigned.
Unlike the MDR, the IVDR considers IVD kits as fully-fledged in vitro diagnostic medical devices; hence, IVD kits are treated like all other IVDs, are subject to the same requirements, must be adequately CE marked, and are classified based on risk.
What Obligations Exist for Manufacturers of Medical Device Kits and Systems?
Manufacturers of procedural systems and kits are also required to draft a specific declaration. This is a document in which the manufacturer declares the combination of CE-marked devices with other devices or products, in a manner compatible with the intended use of the devices or other products and within the limits of use specified by their manufacturers, to market them as a system or procedural kit.
Additionally, they must ensure that the system or procedural kit has labeling that complies with MDR requirements and that it includes the name, trade name, or registered trademark of the manufacturer and the address where they can be contacted, so that the manufacturer, whether an individual or legal entity, can be adequately identified and located. The kit, however, as mentioned earlier, will not bear a new CE marking.
What Documentation is Required for Procedural Systems and Medical Devices?
Unlike what is prescribed by the MDR for medical devices, procedural systems or kits do not require technical documentation.
However, their manufacturers must keep a set of documents that, without a specific name in the MDR, has been defined by MedTech Europe as the “Procedure Pack File (PPF).”
The “Procedure Pack File (PPF)” should include:
- A description of the contents of the package
- A description of the products
- A copy of the labeling, including instructions for use (and implant cards, if applicable)
- Adequate information on packaging, including specifications and, if applicable, procedures for relabeling or repackaging
- The UDI assignment procedure
- The outcome of the verification of the mutual compatibility of the products contained within the system or procedural kit
- A description of the process related to the combination/connection of the products
- If applicable, information regarding the sterilization of the system or kit (if the manufacturer sterilizes it for market release), including the certificate issued by the Notified Body
- The declaration required for systems or procedural kits
What Obligations Exist for “Manufacturers” of IVD Kits?
The IVDR does not identify a separate economic operator role for the “manufacturers” of kits. They are, in fact, manufacturers of IVDs in every sense, as defined in the IVDR, and are therefore subject to the same obligations.
For this reason, since IVD kits are standalone in vitro diagnostic medical devices, their manufacturer is required to draft (and then manage) the technical documentation in accordance with Annexes II and III of the IVDR.
What Documentation is Required for IVD Kits?
The main purpose of the technical documentation for an IVD kit is to demonstrate that it is:
- Compliant with the essential safety and performance requirements set out in the IVDR.
- Designed and manufactured in such a way as to ensure its safety and suitability for the intended use.
- Accompanied by adequate information for users and other economic operators.
The TD is structured modularly, with specific annexes defining the informational requirements for different risk classes and product categories.
The essential contents of the TD vary depending on the type of product and its risk class. However, some key elements are common to all IVDs:
- Product Description: Identification of the product, technical specifications, intended use.
- Design and Manufacturing Specifications: Materials used, production processes, quality controls.
- Conformity Assessment: Tests conducted, risk analysis, clinical evaluation (if applicable).
- Risk Management: Identification of risks, control measures, post-market surveillance system.
- Description of Accessories, other devices (MD and/or IVD), and other products not classified as devices, intended to be used in combination in the kit.
- User Manual and Other Information for Users.
The Technical Documentation for IVD kits must also include specific information regarding the reagents and other materials included in the kit, as well as their diagnostic performance. In particular:
- Specifications of Reagents and Materials: Composition, origin, stability, analytical characteristics.
- Diagnostic Performance: Sensitivity, specificity, accuracy, reproducibility, limits of detection and quantification.
- Quality Control: Procedures for quality control of reagents and materials.
- Interpretation of Results: Guidance for the correct interpretation of diagnostic test results.
The Technical Documentation must be written clearly, concisely, and understandably, using appropriate technical terminology. It must be updated regularly to reflect any changes to the product, manufacturing process, or regulatory requirements.
What Conclusions Can Be Drawn?
Both the Procedure Pack File of medical device procedural systems and the Technical Documentation of IVD kits are fundamental pillars for their marketing in Europe. Drafting these documents clearly, completely, and in compliance with regulatory requirements is not only a legal obligation to obtain the necessary market authorization but is also essential for demonstrating the safety and efficacy of the product that will be marketed, thereby ensuring the highest possible level of public health and safety.
If doubts arise in compiling these fundamental documents, it is highly advisable to consider engaging qualified experts in the regulation of medical devices and IVDs, both to facilitate the swiftest possible market entry and, above all, to ensure compliance with ethical standards towards users and patients.
