MDR Systems and procedure packs

 MDR Definitions:

procedure pack’ means a combination of products packaged together and placed on the market with the purpose of being used for a specific medical purpose;

system’ means a combination of products, either packaged together or not, which are intended to be inter- connected or combined to achieve a specific medical purpose;

Article 22(2) Statement :

System and procedure pack manufacturer shall prepare a statement to declare that,

• Mutual compatibility of the CE marked devices has been verified
• Packaged the system or procedure pack and supplied relevant information to users (Label and IFU)
• activity of combining devices was subject to appropriate methods of internal monitoring, verification and validation(sterilization)

They draw up a statement declaring that sterilisation has been carried out in accordance with the manufacturer's instructions.

Conformity assessment:

Notified body involvement is limited to the aspects of the procedure relating to ensuring sterility until the sterile packaging is opened or damaged.

apply one of the procedures set out in Annex IX or the procedure set out in Part A PRODUCTION QUALITY ASSURANCE of Annex XI+ Article 22 statement

System and procedure pack manufacturer contact details ( name, registered trade name or registered trade mark ) need to be included in labelling. Article 22 (2) shall be kept at the disposal of the competent authorities.

Cases in which System and procedure pack treated as a device in its own right:

• Devices which do not bear the CE marking
• Chosen combination of devices is not compatible in view of their original intended purpose
• Sterilisation has not been carried out in accordance with the manufacturer's instruction

Source:
REGULATION (EU) 2017/745 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC