What is PD CEN/TR 17223 - Relationship between EN ISO 13485: 2016 and European and in vitro diagnostic medical devices regulation about?
PD CEN/TR 17223 discusses the relationship between EN ISO 13485: 2016 (medical devices – quality management systems – requirements for regulatory purposes) and European medical devices regulation and in-vitro diagnostic medical devices regulation.
PD CEN/TR 17223 guides on the relationship between EN ISO 13485:2016, medical devices – quality management systems – requirements for regulatory purposes, and the requirements in EU Regulation 2017/745 on medical devices and EU regulation 2017/746 on in vitro diagnostic medical devices.
As the requirements are integrated and built on each other, all the requirements under PD CEN/TR 17223 apply to the organizations’ activities and the applicable regulatory requirements need to be applied.
Note: It is not intended that requirements be implemented in isolation from the complete system.
Who is PD CEN/TR 17223 - Relationship between EN ISO 13485: 2016 and European and in vitro diagnostic medical devices regulation for?
PD CEN/TR 17223 on the relationship between EN ISO 13485: 2016 and European Medical Devices Regulation and In Vitro Diagnostic Medical Devices Regulation is useful for:
- Organisation or institutions involved in design and development, production, storage and distribution, installation, or servicing of a medical device
- Organisation or institutions involved in one or more stages of the life cycle
- Suppliers or external parties that provide products, including quality management system-related services, to such organizations.
- Organisation or institutions involved in design and development or provision of associated activities of medical devices
Why should you use PD CEN/TR 17223 - Relationship between EN ISO 13485: 2016 and European and in vitro diagnostic medical devices regulation?
EN ISO 13485 describes a quality management system that applies to medical devices and is intended for regulatory purposes. The European regulations for medical devices and EN ISO 13485 present holistic requirements for systematic application of a process approach to quality management into which an organization can incorporate regulatory requirements that apply to its activities.
PD CEN/TR 17223 guideline assists you with conformity assessment bodies on the relationship between EN ISO 13485:2016 and the European Regulations for Medical Devices and in vitro diagnostic medical devices.
This ensures that a process is in place to address quality management system aspects related to medical devices, which are included in article 10 and annexes IX and XI of the regulations.
In addition, PD CEN/TR 17223 also ensures the general safety and performance of these medical devices