The requirements pertaining to system and procedure packs can be found in Article 22 of EU MDR 2017/745. This article aims to shed light on the key requirements concerning the management of system and procedure packs and provide practical insights into their implementation.
System and procedure packs are closely interconnected with other topics that have been extensively covered on our website. These topics include the Unique Device Identification (UDI) system and the obligations imposed on economic operators. Understanding the relationship between these aspects contributes to a comprehensive understanding of the regulatory landscape surrounding medical devices.
In the forthcoming discussion, we will delve into the essential requirements outlined in Article 22, addressing how manufacturers can effectively manage system and procedure packs. By exploring the practical implications and considerations associated with these requirements, we aim to offer valuable insights to manufacturers and stakeholders in the medical device industry.
Some definitions
Before delving into the specific requirements, it is important to provide some key definitions that will help contextualize the discussion.
Firstly, let’s define a “Procedure Pack” or “kit” as a collection of products that are packaged together and made available on the market with the intention of being used for a specific medical purpose.
Next, we have the term “System,” which refers to a combination of products that can be either packaged together or separately, but are designed to be interconnected or combined in order to achieve a specific medical objective.
Lastly, we need to clarify the role of the “Procedure Pack Producer,” who is the individual or entity responsible for placing the Procedure Pack on the market, in accordance with the requirements outlined in the Medical Device Regulation (MDR). It is worth noting that, as per the MDCG 2018-03 guidance document, the Procedure Pack Producer is considered an economic operator.
By establishing these definitions upfront, we can ensure a shared understanding of the key terms and concepts that will be discussed further regarding the requirements related to system and procedure packs. This will facilitate a more comprehensive and accurate exploration of the regulatory framework surrounding these medical devices.
Requirements for Management of Systems and Procedure Packs
Medical devices bearing a CE marking can be assembled and combined in a way that aligns with their intended purpose and the usage limits specified by the manufacturers. This allows them to be marketed as a system pack. To facilitate this process, the individual or entity responsible for the combination should prepare a statement affirming the following:
- Verification of compatibility between the devices.
- Inclusion of appropriate user information in the pack.
- Implementation of internal monitoring, verification, and validation activities specific to the combined devices.
The following types of devices can be combined together:
- Other devices that bear the CE marking.
- In vitro diagnostic medical devices that bear the CE marking in compliance with EU IVDR 2017/746.
- Other products, including non-medical devices, as long as they adhere to relevant legislation. However, their inclusion in the system or procedure pack must be justified within a medical procedure context.
It is essential to ensure that the combined devices meet the necessary requirements and function harmoniously to achieve their intended purpose.
Conformity Assessment
he certification of the natural or legal person responsible for sterilizing systems or procedure packs is crucial. They must be certified in accordance with Annex IX (Conformity assessment based on a quality management system and on technical documentation) or Part A of Annex XI (Production Quality Assurance). The involvement of the notified body and the application of procedures should be limited to aspects related to ensuring sterility until the sterile packaging is opened or damaged. Additionally, the sterilizer must draft a statement confirming that the sterilization process has been conducted in accordance with the manufacturer’s instructions.
Certain situations require the system or procedure pack to be treated as a device on its own, necessitating a standard conformity assessment under Article 52 of the EU MDR. These situations include:
- If the system or procedure pack contains devices that do not bear the CE marking.
- If sterilization has not been performed following the manufacturer’s instructions.
- If the chosen combination of devices is incompatible considering their original intended purpose.
In such cases, it is essential to assess the conformity of the system or procedure pack to ensure its compliance with regulatory requirements and to safeguard the safety and effectiveness of the devices within the pack.
Registration and UDI requirements for Systems and Procedure Packs
The producer of the system or procedure pack is required to apply for registration and obtain a System or Procedure Pack Registration Number (SRN). Additionally, the Universal Device Identifier (UDI) registration is applicable to system and procedure packs.
Regarding UDI, the Basic UDI-DI serves the purpose of identifying systems or procedure packs that share the same group of components and have the same intended purpose, irrespective of the manufacturers of the original components. This ensures traceability and facilitates the identification and tracking of system and procedure packs throughout their lifecycle.
The implementation of UDI for system and procedure packs enhances patient safety, enables effective post-market surveillance, and streamlines the management of these packs across the healthcare system. It enables healthcare professionals to quickly and accurately identify and retrieve relevant information about the components contained within the packs, aiding in efficient and appropriate use.
Subscribe to 4EasyReg Newsletter
4EasyReg is an online platform dedicated to Quality & Regulatory matters within the medical device industry. Have a look to all the services that we provide: we are very transparent in the pricing associated to these consulting services.
Within our WebShop, a wide range of procedures, templates, checklists are available, all of them focused on regulatory topics for medical device compliance to applicable regulations. Within the webshop, a dedicated section related to cybersecurity and compliance to ISO 27001 for medical device organizations is also present.
As one of the leading online platforms in the medical device sector, 4EasyReg offers extensive support for regulatory compliance. Our services cover a wide range of topics, from EU MDR & IVDR to ISO 13485, encompassing risk management, biocompatibility, usability, software verification and validation, and assistance in preparing technical documentation for MDR compliance.
Do not hesitate to subscribe to our Newsletter!
