Swiss notified body to exit sector, heightening EU capacity fears

Dive Brief:

QS Zürich has become the latest notified body to withdraw from the sector ahead of the implementation of new medical device rules, according to Regulatory Focus.
The decision to close the medical device department by the end of October reflects a belief that the investment required to continue is “too high” for the small notified body.
QS Zürich’s withdrawal will leave Swiss Association for Quality and Management Systems as the only medical device notified body in the country. Switzerland has no in-vitro diagnostic notified bodies.

Dive Insight:

News of QS Zürich’s decision continues a spate of withdrawals that add to concerns about whether the European Union will have the notified body capacity needed to support the incoming Medical Device Regulation.

Last week, Lloyd’s Register Quality Assurance said it would withdraw its medical device notified body service, leaving the U.K. with three designated providers. Shortly before that, the Spanish Agency of Medicines and Medical Products detailed plans to exit the sector in a move that will leave the country without a medical device notified body.

Switzerland’s ranks of medical device notified bodies have been thinned by a series of withdrawals in recent years. When QS Zürich pulls out, it will become the fourth Swiss organization in five years to stop serving as a medical device notified body.

The series of exits reflect changes to the regulation of medical devices. In 2014, QS International said the new EU requirements exceeded its capabilities, echoing the comments made QS Zürich. QS International now works with a Turkish notified body to evaluate the conformity of medical devices as part of a consortium.

As its peers dropped out, QS Zürich showed signs that it remained committed to the sector. In September, the company appointed a new head of medical devices and tasked them with helping clients with the outgoing and incoming certification processes. However, the company said the returns no longer justify the required investment.

QS Zürich’s cessation of medical device notified body services is part of the organization’s broader retreat from conformity assessments. QS Zürich used to offer conformity assessments for equipment and protective systems intended for use in potentially explosive atmospheres.

However, the company withdrew its services last month and removed information about them, along with its certification of an associated ISO standard, from its website. Once QS Zürich withdraws its medical device service, it will no longer be designated as a notified body for any EU legislation. QS Zürich will continue to certify companies against an ISO medical device quality management systems standard.