EU Regulation of Medical Device Systems and Procedure Packs under Article 12
What is Article 12?
When a company combines medical devices that each bear their own CE marking and the products are intended to be used according to the CE marking, the assembly is referred to as a “system” or “procedure pack”. For the purpose of this paper, we will refer to the assembly as a “system”.
Article 12 of the Medical Devices Directive (MDD) 93/42/EEC defines the conformity assessment necessary to configure individual medical devices into a system and to ensure safety when putting these systems into service and during use.
For Article 12 to apply, each individual medical device that makes up a system must bear its own CE marking.
Article 12 typically applies to the scenario where devices from multiple manufacturers and different Notified Bodies (if applicable) are assembled together to form a single unit. When a manufacturer combines only its own devices into a system, those devices fall under Article 11 requirements and Article 12 most likely does not need to be considered. However, it is ultimately the responsibility of the assembler to determine the applicability of Article 12 to the devices.
System assembler responsibilities
The system assembler assumes the responsibility of verifying the compatibility of the devices, packaging the system, supplying relevant information to the user and performing the assembly under appropriate methods of internal control and inspection. The assembler must be able to provide a signed declaration that these responsibilities have been satisfied.
As a legal manufacturer, the assembler has reporting duties to the EU Competent Authorities. This includes the registration of the system with the Competent Authority in the European Union member state where the assembler or its Authorized Representative is established.
Verifying mutual compatibility
As mandated under Article 12, the system assembler must verify the “mutual compatibility” of the individually CE marked devices. The mutual compatibility of the devices must be based on the intended use and limits of use for each device as specified by the original device manufacturer. Upon assembly of the system, the intended use of the individual devices cannot change from the scope specified by the original manufacturer.
The system assembler is declaring that, based on the instructions for use available for each component (medical device) of the system, the devices are compatible and able to work together as assembled in order to ensure the safe and proper use of the system. The declaration also implies that the specified performance of the individual devices has not been impaired.
What if the products in a system are not all medical devices? Each component should be assessed to understand the regulatory requirements of each individual component. And, the appropriate regulatory compliance must be obtained for the product. For example, if the system includes pharmaceutical products, those products must be compliant to the Medicinal Product Directive 2001/83/EC and the products must be labeled accordingly. The risk assessment should document that these medicinal products are to be used as intended by the medicinal product manufacturer and provided with the relevant information for use.
Packaging your system and supplying relevant information
Assemblers must package their system according to the specifications defined by the original manufacturers of the individual devices. These specifications include the intended use and restrictions for use established for the individual devices. Additionally, the specifications define the conditions under which the CE-marked devices can be assembled and placed on the market as a system.
Assemblers of the system should always ensure that each of the individual devices bears a CE marking and that the original manufacturers have the appropriate approvals in place. It is in the assembler’s best interest to request a Declaration of Conformity to the MDD from each original device manufacturer and, if applicable, the Notified Body certificate that provides objective evidence of an assessment performed under the appropriate procedure specified in Article 11 of the MDD.
It is important to note that in the final assembled system, each individual medical device maintains and bears its own CE marking; however, the assembled system itself does not bear a CE marking.
If an assembler affixes a CE marking to the overall system, this implies compliance with Article 11 and review by a Notified Body, presuming the devices are higher risk than Class I self-certified.
Relevant information regarding the safe and proper use of the system must also accompany the system. This information must comply with requirements specified in Annex I (13) of the MDD and include, where appropriate, the information supplied by the original device manufacturers.
Assembly under internal control and inspection
The assembler must declare that the “whole activity” of the Article 12 procedure has been subjected to appropriate methods of internal control and inspection. It is in the best interest of the assembler to define what method of control and inspection has been applied to the Article 12 system and how these methods are deemed “appropriate” for the system.
Declaration of conformity
A declaration of conformity to Article 12 must be generated and signed stating that the assembler has:
- Verified the mutual compatibility of the devices in accordance with the manufacturers’ instructions and has carried out his operations in accordance with the instructions; and
- Packaged the system or procedure pack and supplied the relevant information to users incorporating relevant instructions from the manufacturers; and
- The whole activity is subjected to appropriate methods of internal control and inspection.
All Article 12 declarations must be kept at the disposal of the competent authorities for a period of five years.
Wrapping up: points of consideration
When a system incorporates devices that do not bear their own individual CE marking, the system does not fall under Article 12 and must be subjected to the relevant procedure pursuant to Article 11 of the MDD.
If a combination of devices is not compatible with their original intended use, the system does not fall under Article 12 and must be subjected to the relevant procedure pursuant to Article 11.
Even if Article 12 can be applied to a particular system, the assembler can always elect to treat the system as a device in its own right and apply the relevant procedure pursuant to Article 11 of the MDD. If the system will be covered under Article 11, the system must possess a Notified Body issued CE marking certificate.
The intent of Article 12 is to provide a simplified regulatory mechanism so that medical device components which have been subject to the appropriate regulatory compliance can be assembled, largely as a convenience (to borrow a term from the FDA) to the user.