New MDCG Device Specific Vigilance Guidance Documents Published

By Amelia Boldrick and Beth Pugh

The European Commission’s Medical Device Coordination Group (MDCG) published several updated Device Specific Vigilance Guidance (DSVG) documents on January 30. The newly released guidance documents cover four of the original five specific devices to which the now-obsolete MEDDEV DSVGs once applied: cardiac ablation, coronary stents, cardiac implantable electronic devices and breast implants. The DSVG aims to harmonize vigilance reporting for manufacturers of these specific devices. Each guidance includes device-related problem examples for individual serious incidents, periodic summary reports or incidents which would be reported at the time a trend is identified.

Specific changes to the Device-Specific Vigilance Guidance documents

A few changes have been incorporated into all of the new DSVG documents. These now reference the Regulations and MDCG 2023-3 instead of the Directives (MDD or AIMD) and the former guidance on vigilance (MEDDEV 2.12/1 rev 8). They also now include the International Medical Device Regulators Forum (IMDRF) codes associated with the incident examples included in each DSVG document. Manufacturers should understand that the incidents provided in the DSVG are intended to serve as examples only and are not to be considered an all-inclusive list.

The table below provides links to the old and new versions of the DSVGs and a brief overview of some specific changes to incident examples that manufacturers of the corresponding devices may find of interest.

*Subject to agreement by the coordinating competent authority

EU DSVG and the UK

For manufacturers who also market their devices in the UK, the Medicines and Healthcare products Regulatory Agency (MHRA) has a substantial list of DSVG published on their website, which includes the MEDDEV DSVG outlined in the table above, as well as artificial heart valves, blood glucose meters, implantable electronic devices, inferior vena cava filters, intraocular lenses, joint replacement implants, neurostimulators and software as a medical device. For those devices for which the EU published a DSVG under the MEDDEV, the links on the MHRA website are redirected to the EU Commission website for download. MHRA published all other DSVG.

Concluding remarks

We anticipate an updated MDCG 2023-3 guidance document to include the IVDR, as well as updated vigilance reporting forms soon.