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Regulatory Focus™ > News Articles > 2019 > 4 > Swiss Medtech Group Warns of What’s to Come Without Updated EU MRA

Swiss Medtech Group Warns of What’s to Come Without Updated EU MRA

Posted 25 April 2019 | By Ana Mulero 

Swiss Medtech Group Warns of What’s to Come Without Updated EU MRA

Switzerland’s medical technology lobbying group issued recommendations to manufacturers Thursday to prepare for different possible regulatory scenarios because of uncertainty with the Institutional Agreement between the EU and Switzerland (InstA).

Stalling the InstA “directly affects the medical technology sector,” said Swiss Medtech. The group noted challenges with not knowing whether support for the InstA will be voiced and whether Switzerland and the EU’s Mutual Recognition Agreement (MRA) will be updated over the course of 2019. Swiss device manufacturers may have to meet the requirements of a third country in order to be permitted to export products to the EU in accordance with the new EU Medical Device Regulation (MDR).

“Barrier-free access to the EU single market can only be achieved by updating the Mutual Recognition Agreement (MRA) between Switzerland and the European Union,” Swiss Medtech said.

But the group also called on all Swiss manufacturers to prepare for meeting the third country requirements of MDR and for the unknown implications of Brexit.

Regardless of whether third-country requirements will apply, the group recommended that Swiss device manufacturers seeking to export products under MDR to prepare to appoint an EU-based authorized representative and alter product labels by supplementing each with the authorized representative and importer.

“Depending on the complexity and scope of the product range, meeting these two requirements can take two years,” said Swiss Medtech President Beat Vonlanthen.

Swiss Medtech added that another scenario manufacturers should prepare for is the possibility that Notified Bodies’ (NBs) capacity for timely MDR certification will be insufficient. This underscores the concerns facing industry around NBs’ timely availability and readiness for MDR.

Recent Team-NB surveys confirmed the looming shortfalls of NBs under not just MDR, but also the EU’s in vitro diagnostic regulation (IVDR). This is among the concerns MedTech Europe CEO Serge Bernasconi cited in a letter sent to the EC earlier this month, arguing that the transition to MDR/IVDR is “clearly untenable.” Only one NB—BSI UK—has been designated against MDR and none have been designated against IVDR thus far.

A lack of NB certification capacity to complete the transition to MDR and IVDR by 26 May 2020 and 26 May 2022, respectively, in time “would also make it likely that exemptions will have to apply,” said Swiss Medtech. “It is currently not foreseeable to what extent any supply bottlenecks could influence the transition periods of the current and future regulations” post-Brexit, which is now set for 31 October.

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