ACTIVE MEDICAL DEVICES
IMPLANT MEDICAL DEVICES
DISPOSABLE MEDICAL DEVICES
SOFTWARE MEDICAL DEVICES
IVD MEDICAL DEVICES

EU MDR Technical File and PMS Documentation

MDR requirements are complemented by harmonized standards EN ISO 13485 and EN ISO 14971. In addition to the pre-market assessment of risks associated with a new device, EN ISO 14971:2012 specifies requirements for production and post-production information to be considered as part of the overall risk assessment process throughout the life of the device.

EU Medical Devices Regulation (2017/745) increases requirements for post-market surveillance (PMS). Article 61 detailing Clinical Evaluation and Articles 82-86 / Annex III detailing Post Market Surveillance, and Annex XIV detailing PMCF requires modification in appropriate functional areas to your existing practices

MDR Article 83 requires an active PMS monitoring system for each medical device sold in the European market must be covered in your QMS system.

PMS activities must link with QMS activities

  • Medical Device Technical Documentation,
  • Design and Development activities after market release,
  • After sale feedback and customer complaint handling,
  • Vigilance Issues,
  • Product recalls and alerts/notices,
  • Management Review,
  • Risk Management,
  • Device Labeling,
  • Clinical Evaluation,
  • Corrective and Preventive Action,
  • Periodic Safety Update Report,
  • Summary of Safety and Clinical Performance in technical documentation,