The new European Legislation that replaces the current directives aimed at manufacturers and other economic operators for medical devices (MDR), is changing the regulatory framework of over ten years. One of the news are the significant strengthening of the Vigilance System and post-marketing surveillance, introducing a more severe post-marketing supervision from the notified EU bodies, that have more authority in defending the EU citizens health and safety.

The surveillance system aims to improve safety of patients, users and other involved players, and this goal is pursued through the participation of all the “system” players that will implement it following new regulations.

The post-marketing surveillance system aims to collect, register and actively and systematically analyse data regarding quality, performance and security of a medical device during the life cycle, to draw conclusions and determine, carry out and monitoring preventive and corrective actions.

In sight of the full application of the Community Regulations in effect since 25 May 2017 – fixed from 26 May 2020 for the Regulation (EU) 2017/745 on medical devices (MDR) and from 26 May 2022 for the Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) – the European Commission has recently published the document: Additional Guidance Regarding the Vigilance System as outlined in MEDDEV 2.12-1 rev. 8, that gives more indications on surveillance system of medical devices, in detail:

  • It clarifies some existent definitions
  • It introduces a new Manufacturer’s Incident Report (MIR), mandatory starting from January 2020, and a new template for the Field Safety Notice (FSN)
  • It introduces the Device Specific Vigilance Guidance (DSCG)
  • It gives additional information on coordination area for supervisory issues (role of vigilance taskforce)
  • It clarifies the differences between EU NCAR exchange and IMDRF NCAR exchange

The Device Specific Vigilance Guidances (DSVGs) helps manufacturers in:

  • Identifying incidents and complaints on medical devices
  • Identifying an incident that must be notify to the Competent Authority
  • reporting practice to be used come, through Individual Incident Reporting, Periodic Safety Reports or trends Reports

The DSVGs are available on Current directive guidance on European Commission website, that shows the most recent revision of the forms for the Suirveillance System on Medical Devices, as well as the attachments regarding the guideline MEDDEV 2.12-1 rev. 8, 2013.

The European Commission provides additional guidelines to support stakeholders in the implementation of Medical Devices regulations.

To ensure the uniform application of the Regulations within the European Union, the Medical Device Coordination Group – MDCG has adopt these guidelines (not legally binding) and made them available on the dedicated page on European Commission website , according to Article 105 of the Regulation 745/2017.

How to get prepared for regulatory changes in the company?

Unannounced audits, together with sample checks and product tests will reduce risks related to the use of medical devices. In many cases will be requested annual safety reports on the performance of devices manufacturers. The application of new Regulations aims to protect public health.

Therefore, its introduction will determine an increase in time and resources needed by manufacturers to implement what is in the regulations; it is likely that this will make this transitional moment particularly complex for most medical device manufacturers.

Through Regulatory Affairs and Materiovigilance outsourcing services for companies, our JSB experts support manufacturers in compliance activities, in risk management and in protection and promotion of patient health. We give assistance to manufacturers during the process to adapt to new requirements, with timeliness and the necessary skills.

Marcella-Falcone-Pharmacovigilance-Manager

Marcella Falcone

Pharmacovigilance Manager

m.falcone@jsb-solutions.com

An extensive experience in the consulting world, working as Pharmacovigilance Manager and a career as QPPV, Deputy QPPV, LCP with a background  in pre and post-marketing pharmacovigilance field, but also in the vigilance on Medical Devices and on Cosmetics Products.