MDSSAR News & Events

2023-10-13T20:37:19+02:00

Revision of MedDO and IVDO

New requirements for product groups without an intended medical purpose and alignment with Regulation (EU) 2023/607 on medical devices and in vitro diagnostic medical devices.

The Federal Council of Switzerland has decided to amend the Medical Devices Ordinance (MedDO) in alignment with EU requirements (Implementing Regulation 2023/1194), for product groups without an intended medical purpose.

The amendments on EU-MDR 2017/745, regarding changes to transitional periods for certificates, and on EU-MDR 2017/745 and EU-IVDR 2017/746, regarding the elimination of the sell-off period, were also transposed to the MedDO and IvDO. The approved amendments to the MedDO and IvDO will become effective on 1st November 2023.

More details can be found in the Swissmedic publication.

Categories: News

Tags: Switzerland Swissmedic

2023-03-31T17:44:06+02:00

Swissmedic inspects Class I manufacturers in Switzerland!

Swissmedic evaluated compliance declarations from a random sample of 27 Swiss manufacturers of Class I medical devices between August and December 2022. The results revealed poor performance among manufacturers, with 70% of post-market surveillance (PMS) documentation failing to meet legal standards!

Furthermore, 14% of the manufacturers were not registered with Swissmedic, 39% of verified Class I devices were not notified correctly and 11% were unable to demonstrate compliance with new legal requirements.

Swiss Medtech urges all Class I medical device manufacturers to promptly assess and correct any compliance issues to comply with legal requirements.

Here you can find the full report.

According to the report, Swissmedic has initiated a focus campaign to assess the implementation of the new regulation for class I devices, which are not monitored by a Notified Body. Similar campaigns are also expected in the EU, as outlined in section 3 of the MDR, which details the market surveillance requirements for the Competent Authorities. Article 93 states:

The competent authorities shall perform appropriate checks on the conformity characteristics and performance of devices …
The competent authorities shall draw up annual surveillance activity plans …

It is important to note that the surveillance activities of Swissmedic and other EU authorities will not be limited to risk class I devices/manufacturers. MDSS anticipates that such investigations will continue in the coming years as manufacturers adjust to the new regulation. Therefore, the Swissmedic investigation in 2023 should come as no surprise, especially for class I products that should have been complying since May 2021.

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Categories: News

Tags: Swissmedic Switzerland

2023-01-26T00:00:00+01:00

Handling of Certification Gaps according to MDCG 2022-18

The Medical Device Coordination Group (MDCG) has released a new document that provides guidance on handling certification gaps for medical devices in the EU/EEA. The document, MDCG 2022-18, addresses the procedures for handling certification gaps for medical devices in the EU/EEA and provides guidance on market surveillance procedures for member states...

Overview: Handling of Certification Gaps according to MDCG 2022-18 in Switzerland

MDCG 2022-18 outlines the procedures for handling certification gaps for medical devices in the EU/EEA. The document provides guidance on the steps that should be taken by member states to ensure that medical devices are safe and effective. It also addresses the procedures for market surveillance and the measures that should be taken by market surveillance authorities in the event of a certification gap.

Reliance on MDCG 2022-18 Confirmations of EU/EEA Member States

MDCG 2022-18 also provides guidance on the reliance on confirmations of EU/EEA member states. The document states that member states should rely on the confirmations of other EU/EEA member states when assessing the safety and effectiveness of medical devices. This helps to ensure that medical devices are safe and effective

Market Surveillance Procedures according to MDCG 2022-18 in Switzerland

MDCG 2022-18 also provides guidance on market surveillance procedures for member states. In Switzerland, the procedure for market surveillance is outlined in the document, including the steps that should be taken by market surveillance authorities in the event of a certification gap.

Surveillance and Measures by Swiss Market Surveillance Authorities

The document also addresses the surveillance and measures that should be taken by market surveillance authorities in Switzerland. This includes procedures for monitoring the market for medical devices and taking appropriate measures in the event of a certification gap.

Free Sales Certificates

MDCG 2022-18 also provides guidance on the issuance of free sales certificates for medical devices. This includes the conditions that must be met for a device to qualify for a free sales certificate and the procedures for issuing the certificate.

Frequently Asked Questions

The document also includes a section with frequently asked questions about the handling of certification gaps for medical devices in the EU/EEA. This provides additional information and clarification on the procedures outlined in the document.

You can download the document here.

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Categories: News