Understanding Systems and Procedure Packs in Accordance with EU MDR

In today's healthcare system, the role of system and procedure packs is of great importance. Since these packs contain tools that are needed to carry out a medical procedure and them being sterilized, it reduces the burden for sterilizing or missing out on a tool needed to perform the procedure. It saves preparation time, contamination prevention and the need to gather tools separately.

The European Union Medical Device Regulation (EU MDR) has introduced  significant changes in the regulatory framework for medical devices in Europe. Regulation of medical procedure packs and system packs have undergone notable adjustments. Article 22 of EU MDR 2017/745 outlines the regulatory requirements for both system and procedure packs.

Understanding Systems and Procedure Packs.

According to Article 2 (10) of the EU MDR, a procedure pack is a combination of products packaged together and marketed for use in a specific medical procedure. These packs consist of a set of medical devices and/or accessories bundled together to facilitate a particular medical task. Examples include orthodontic procedure packs, skin traction kits, first aid kits, catheterization kits, and wound change kits.

According to EU MDR Article 2(11), a system refers to a combination of products, whether packaged together or not, intended for interconnection or combination to achieve a specific medical purpose. System packs contain various products (ranging from diagnostic equipment to surgical instruments) that are designed to function as a system to carry out a specific medical procedure or purpose. The X-ray system is an example for this.

Components of Systems and Procedure Packs

A procedure pack can include solely medical devices, but it may also contain other product types that are subject to different regulations. Medical devices bearing a CE marking can be combined in a manner consistent with their intended purpose and manufacturer's usage limits, allowing them to be marketed as a system pack. The following types of devices can be combined together:

• Other devices bearing the CE marking.

• CE marked In vitro diagnostic medical devices in compliance with EU IVDR

• 2017/746.

• Other products, including non-medical devices, provided they adhere to relevant legislation whose inclusion in system or procedure pack is justified within a medical procedure context.

CE Marking of System and Procedure Packs

The System and procedure packs themselves are not considered medical devices and do not require a CE marking. Producers of these packs are not subjected to the same requirements as medical device manufacturers. They shall bear the name, registered trade name, or registered trademark of the person along with the contact address. The system and procedure pack may be deemed a device on its own and must undergo CE marking in circumstances where -

•  The pack contains devices without CE marking.

•  The combination of devices is incompatible with their original intended purpose.

•  The sterilization has not been carried out as per manufacturer's instructions.

Conformity Assessment of System and Procedure Packs

The SPP (Systems and procedure packs) containing devices without CE marking or those sterilized not in line with manufacturer's instructions, or the combination of devices is incompatible with their original intended purpose must undergo a conformity assessment as a device on its own. In such cases, the SPP takes on the obligations of a manufacturer and must comply with the relevant conformity assessment procedure outlined in MDR Article 52.

System and Procedure Pack Producer vs. Manufacturer

According to MDCG 2018-03 guidance both System and procedure pack producers and manufacturers are categorized as "Economic Operators", each having specific obligations. System or procedure pack producers are natural or legal persons who combine medical devices bearing a CE marking, either alone or with other products that comply with the relevant legislation, to place them on the market as system or procedure packs.

Under certain conditions, a system or procedure pack producer may become a manufacturer.

•  The pack contains devices without CE marking.

•  The combination of devices is incompatible with their original intended purpose.

•  The sterilization has not been carried out as per manufacturer's instructions.

In such cases, they must comply with the same legal obligations as a medical device manufacturer, including conducting the relevant conformity assessment procedure for the system and procedure pack, essentially designating it as a medical device in its own right.

Risk Classification of Systems and Procedure Packs

Systems and procedure packs themselves are not assigned individual risk classifications. The risk classification, however, is required for entering information in the EUDAMED registration database and determining applicable MDR deadlines, such as when affixing the UDI carrier. The manufacturers should apply the classification of the highest-risk device within the System and Procedure pack.

EU Medical Device Classification

Medical devices are divided into 4 classes (based on their risk level for its intended purpose) as per the classification rules.

CLASS	RISK CLASSIFICATION
CLASS I	Low risk, Noninvasive
CLASS Is	Device to be marketed in sterile condition under class I
CLASS Im	Devices with measuring function under class I
CLASS Ir	Reusable surgical instruments under class I
CLASS IIa	Low to medium risk. For devices installed in the body for a short term (60 min to 30 days).
CLASS IIb	Medium to high risk. For devices installed in the body for 30 days or more.
CLASS III	High Risk

Technical File for Systems and Procedure Packs

Unlike medical devices, systems and procedure packs do not require a Technical Documentation File. However, system and procedure pack producers should maintain documentation -

•  Contents of the procedure pack.

•  Descriptions of the products.

•  Labeling, including instructions for use (and implant cards, if applicable).

•  Packaging information.

•  An outline of the UDI procedure.

•  Verification of the mutual compatibility of the products within the pack.

•  Information regarding the process of combining products.

•  Details related to the sterilization including the Notified Body certificate.

•  The system/procedure pack declaration.

Utilizing MDD/AIMDD Legacy Devices in Systems and Procedure Packs

A system/procedure pack may include only legacy devices compliant with the Medical Devices Directive (MDD) or the Active Implantable Medical Devices Directive (AIMDD), only MDR CE-marked devices, or a combination of both.

• If the pack contains only legacy devices, it is treated as a legacy system/procedure pack and continues to be marketed under Article 12 of the MDD, with additional requirements under MDR Article 120(3) for legacy devices.

• If the pack contains only MDR devices, it is subject to Article 22 of the MDR.

• If the pack combines legacy and MDR devices, it is considered a transitional system/procedure pack. In such cases, it must be CE marked under the MDR, but the legacy devices may be marketed in the pack until their certificate's expiration or until May 27, 2024, whichever comes first.

Importantly, any modification or extension of the intended purpose of a legacy device in a transitional system and procedure pack will subject that device to full MDR compliance, including the need for a new conformity assessment.

Appointing a European Authorized Representative for System and Procedure Packs

The System and Procedure Pack producers based outside of the European Economic Area (EEA) need not appoint a European Authorized Representative (EAR). However, appointing an EAR is essential for foreign manufacturers of individual devices that are CE marked in the system and procedure packs which can be sold separately.

Basic UDI-DI Assignment and UDI Database Registration:

A basic UDI-DI which must be in compliance with the issuing entity should be assigned by the natural or legal person. This information must be fed to the UDI database together with other core data elements.

Difference Between UDI-DI and UDI-PI

The UDI comprises UDI-DI and UDI-PI. UDI-Device Identifier (UDI-DI) is a unique alphanumeric or numeric number which is specific to a device model which is used as an access key for the information stored in the UDI database. UDI-Production Identifier (UDI-PI) is an alphanumeric or numeric code which identifies the unit of device production. Serial number, Lot number, Software Identification, Manufacture or expiry date or both the dates are the information that are included in UDI-PI.

Labeling Requirements for System and Procedure Packs under Article 22(5)

Under the Medical Device Regulation (MDR), SPPs are subject to specific labeling requirements, including:

• SPPs themselves should not bear an additional CE marking.

• The labeling must include the name, registered trade name, or registered trademark of

• the SPP Producer, along with their contact address for location identification.

• The label should contain information specified in MDR Annex I(23) and/or IVDR

• Annex I(20).

• The UDI carrier must be affixed to the outside of the packaging, including both the

• UDI-DI and UDI-PI, in accordance with Annex VI, part C (6.3.3).

• The label should display the expiration date based on the shortest shelf life among the

• components.

• A specific lot number should be provided.

• Information on packaging that maintains the sterile condition of the device.

• The label, declaration, or instructions for use should include a list of components.

The Statement for Systems and Procedure Packs

The System and Procedure Packs Producer must draw a Statement that declares:

•  Verification of mutual compatibility of the devices and, if applicable, other products, following manufacturers' instructions.

•  Packaging of the system or procedure pack and provision of relevant information to users, incorporating the manufacturers' information for the devices or other products

•  Adherence to appropriate methods of internal monitoring, verification, and validation for the combination of devices and products as a system or procedure pack.

MDR Article 22(5) specifies that a template statement can be created by copying the relevant points applicable to the Procedure Pack or System. The Producers of SPPs should maintain evidence of compliance with these requirements. The statement must be available to competent authorities for a specified period, which varies depending on the applicable Article 10(8) duration. For most devices, documentation must be retained for at least 10 years after the last device covered by the EU Declaration of Conformity is placed on the market, or 15 years for implantable devices.

There is no explicit requirement in the MDR to sign and date the statement or add the EUDAMED Actor ID or Basic UDI-DI. However, producers are not prohibited from including these additional identifying details if they wish.

Handling Post-market Vigilance of System and Procedure Packs

The MDR does not provide clear guidance on vigilance reporting for Systems and Procedure Packs. Nonetheless, it is considered best practice for device manufacturers and SPP producers to include vigilance reporting obligations within their agreements. In the event of an incident related to a device within the SPP, the SPP producer should promptly notify the manufacturer to initiate an investigation. The manufacturer is responsible for reporting incidents in line with their vigilance procedure. Similarly, manufacturers should notify the SPP producer of any incidents they become aware of. In cases where the incident directly relates to the SPP producer's activities, such as combination or sterilization, the responsibility falls on them. However, the MDR does not explicitly require SPP producers to report incidents; reporting obligations are identified for manufacturers as a different economic operator role.

Sterilization of System and Procedure Packs

With SPPs requiring sterilization before its introduction into the market, it is essential to gain a certification from a notified body as per MDR Article 22(3). There are specific procedures stated in Annex IX or part A of Annex XI and must follow it.

Steps to Place Systems and Procedure Packs on the EU Market:

To bring Systems and Procedure Packs to the EU market, producers should prepare a Technical File, add the producer's name and address to the pack, appoint an EAR (if applicable), draw up the declaration statement, implement appropriate labels and IFUs, obtain Notified Body involvement for sterilization aspects, receive a CE Certificate, register in the UDI database, and ensure compliance with the minimum information required by MDR Article 22(5).

The system and procedure packs take us a step ahead in assuring the safety of the patient and quality of the product. The EU MDR has set specific regulations for this purpose. The Regulatory bodies, manufacturers and healthcare professionals must work closely and effectively for it to benefit the patients while maintaining compliance with these strict regulatory standards. Regulatory compliance can be challenging most of the time but with proper navigation, these essential tools can be expedited into the market.

Here at Artixio, our regulatory professionals with 15-35 years of experience in various central as well as regional regulatory requirements along with EMA, can guide you in the right direction, provide comprehensive assistance and product market maintenance assuring you a streamlined regulatory approach. Connect with us through info@artixio.com

FAQ’s

Q. What is EUDAMED?

A. EUDAMED is short for European Database for Medical Devices. It collects all the data of the medical devices that are available in the European Union (EU). EUDAMED aims to increase overall transparency by providing better access to information to the healthcare providers as well as the public and enhancing the coordination between different EU member states.

Q. Who is responsible for the Systems and Procedure Packs registration in EUDAMED?

A. The Systems and Procedure Packs producer is responsible for the registration of Systems and Procedure Packs in EUDAMED.

Q. What are the specificities of UDI (Unique Device Identifier)?

A. The specificity of UDI is that it allows for the prevention of counterfeiting, can trace the device more efficiently, easier recall of the medical devices and patient safety can be improved.

Q. What is a legacy device?

A. A legacy device is a medical device, Active Implantable Medical Devices and In Vitro Diagnostic medical devices which were covered under a valid certificate that is issued in agreement with the older Directives, Directive 93/42/EEC, Directive 90/385/EEC or Directive 98/79/EC, and still continued to be placed in the market even after the replacement of these directives with Regulation (EU) 2017/745 (MDR) or Regulation 2017/746 (IVDR).

Q. Do Systems and Procedure packs require clinical trials or testing?

A. Systems and procedure packs as such doesn't need clinical trials because they are made up by collating medical devices (that belongs to different class) to carry out a function altogether. Medical devices belonging to each class may require clinical trials based on the level of risk they possess. Class IIb and Class III medical devices must undergo clinical trials.