Device Vigilance System Additional Guidance: An Update from Our Devices Team

While much of the medical device industry is focused on MDR, the MDD is still in effect.  Our medical devices team has been following the latest developments on MDD and MDR on behalf of our client companies.  In this article she provides an update on the additional guidance issued by the EU Commission regarding the Device Vigilance System as outlined in MEDDEV 2.12-1 rev. 8.

Update: You will see that some of our comprehensive MDR content that we have created refers to the May 2020 date of application.  The date of MDR application has moved to May 26th, 2021.  Articles that were written prior to the delay referenced the earlier date.  However, articles that you might read that reference the earlier date should be read taking the new date of May 2021 into consideration.  Read more here.

On 10th July 2019, the European Commission issued Additional guidance on the EU Medical Device Vigilance system under the current Medical Device Directive.

This additional guidance highlights the update of the Manufacturers Incident Report (MIR) form (MIR) which includes updates such as introduction of an international IMDRF coding/terminology and in preparation of the EU MDR 2017/245, the concept of SRN and the use of UDI.

It is important to note that the updated MIR form becomes mandatory in January 2020.

This additional guidance also refers to the ‘Device Specific Vigilance Guidance’ (available on the EU Commission website) which provide additional information to Manufacturers that can assist them to identify incidents and complaints associated with specific medical devices and help determine if a type of incident is reportable to the Competent Authority.

What is in the additional guidance document?:

• Updates to the definitions of FSCA’s and FSN’S;
• Clarification on the section regarding FSCA’s – i.e. for instances where a device is introduced into a new market after the implementation of an FSN, there is now a recommendation to review whether the risk cited in an FSN remains relevant. This section also recommends that the manufacturer should only exclude a country from FSN distribution if they a robust and objective rationale for its exclusion
• References to availability of the following on the EU Commission website – FSCA template, FSN template, Customer reply, and distributor reply form.
• Provision of further detail in relation to the area of the coordination of Vigilance issues amongst Competent Authorities and for more complex issues, the requirement of a Vigilance task force.
• Clarification on the differences between the EU NCAR exchange and the IMDRF NCAR exchange.
• Details on IMDRF and NCAR exchange
• Reference to availability of the European NCAR form and instructions for completion on the EU Commission website
• Reference to availability of the IMDRF NCAR form and the instructions to complete on the EU Commission website

The additional guidance to the Device Vigilance System should complement and be used in conjunction with MEDDEV 2.12-1 rev. 8, 2013.

This is a time of significant change in the medical devices sector.  Companies in the sector should now be readying themselves for the new medical device regulations (MDR).  MDR is coming in May 2020.  We have produced a number of articles, videos, and publications about the new regulations.  You can download your copy of our first MDR whitepaper below.

Acorn Regulatory Can Help

Acorn Regulatory is at the forefront of ensuring that our client companies are kept up to date with developments in the device sector.  The advent of the MDR coupled with the issues that are arising with Notified Bodies are creating many challenges for device manufacturers.  Our team of medical device experts are working to keep our client companies informed of any changes that are happening in the sector.  If you would like us to assist your company with issues relating to a medical device, then please contact us.  Call us on 00353 52 61 76 706 or complete the form below and we will get back to you.