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Regulatory Focus™ > News Articles > 2020 > 1 > MDCG’s 2020 Meetings to Tackle Clinical Data, Annex XVI, UDIs and More

MDCG’s 2020 Meetings to Tackle Clinical Data, Annex XVI, UDIs and More

Posted 24 January 2020 | By Zachary Brennan 

MDCG’s 2020 Meetings to Tackle Clinical Data, Annex XVI, UDIs and More

As device firms ramp up their final preparations ahead of the 26 May application date for the Medical Devices Regulation (MDR), the European Commission’s Medical Device Coordination Group (MDCG) is planning to host 14 different meetings between now and then.

Kicking off the meetings is a workshop on 3 February on sufficient clinical data, which will likely be of interest to device firms because of the heightened requirements for providing such data for an increasing number of devices under MDR. The MDCG is also expected to release guidance on clinical evaluations sometime in 2020, as well as additional clinical guidance for legacy devices previously certified under the EU device directives.

Ten days after this first workshop, the MDCG will hold another workshop on periodic safety update reports (PSURs), which again, the MDCG says it’s planning to issue guidance on postmarket surveillance requirements.

For higher class devices, such as Class IIa, Class IIb and Class III, PSURs are to be prepared for each device or the device category or group of devices where relevant, according to Adina Chen Bar, a freelance regulatory consultant. The PSUR will provide a summary following the analysis of the postmarket surveillance data (trend analysis, adverse events and actions taken) and include conclusions. MDCG’s postmarket surveillance and vigilance working group is also meeting 20-21 February.

In addition, a meeting on unique device identification (UDI) is also set for 17 February and 20 April, and the MDCG has already published guidance on UDIs in 2018 and 2019.

March meetings will include get-togethers of several MDCG working groups, including ones on clinical investigation and evaluation, notified body oversight, as well as others related to international matters, nomenclature and new technologies. Earlier this month, guidance on Eudamed’s nomenclature was released.

In addition to the UDI meeting in April, only one other meeting has been scheduled for the market surveillance subgroup.

And then on 4 May, a meeting will be held on Annex XVI, which deals with products that a manufacturer claims are only for an aesthetic or other non-medical purpose, but which are similar to medical devices in terms of functioning and risk profile. On 19 May, the MDCG will hold a meeting on in vitro diagnostics.

Many of the aforementioned groups will hold additional meetings throughout the rest of 2020, although other meetings will include discussions on standards (in late May and early June) and borderline cases where it is not clear if a product is a medical device, an in vitro diagnostic, an active implantable device or not (30 November).

Planned meetings of Medical Device Coordination Group (MDCG) and subgroups in 2020

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