• There are no items in your cart

NEN NPR CEN/TR 17223 : 2018

Current
Current

The latest, up-to-date edition.

GUIDANCE ON 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
Published date

04-10-2018

Gives guidance 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.

DocumentType
Standard
PublisherName
Netherlands Standards
Status
Current

Standards Relationship
CEN/TR 17223:2018 Identical

View more information
Sorry this product is not available in your region.

Access your standards online with a subscription

Features

  • Simple online access to standards, technical information and regulations.

  • Critical updates of standards and customisable alerts and notifications.

  • Multi-user online standards collection: secure, flexible and cost effective.