News Category: Regulatory news
On 24 May 2022, the European Commission published a notice to stakeholders on the status of the EU-Switzerland mutual recognition agreement (MRA) for IVDs.
Until now, this MRA has allowed Switzerland to participate in the EU internal market for IVDs by mutually recognising certificates issued by EU and Swiss notified bodies. In addition, Swiss-based manufacturers fulfilled the same requirements as EU-based manufacturers.
This notice clarifies that the chapter of the MRA covering IVDs ceased to apply from 26 May 2022. As a result, Switzerland will no longer participate in the EU internal market for IVDs and will be treated as a third country.
As a result, we would like to highlight the following to our stakeholders:
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Certificates issued by notified bodies established in Switzerland will no longer be recognised as valid in the EU even if they were issued before 26 May 2022.
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For all new IVDs placed on the EU market, Swiss manufacturers will be treated as third-country manufacturers.
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For IVDs placed on the market after 26 May 2022, Swiss manufacturers must designate an EU authorised representative.
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Similarly, from 26 May 2022, third-country manufacturers whose authorised representative was previously established in Switzerland must designate an EU authorised representative.
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Affected stakeholders (manufacturers, importers, distributors and authorised representatives) must fulfil applicable IVDR obligations in full, noting in particular the obligation to appoint an EU authorised representative where applicable and obligations relating to registration and device labelling.
Please note that MRA also ceased to apply for the trade of medical devices between the EU and Switzerland. Specific information about the status of the MRA for medical devices is outlined in the Commission’s notice to stakeholders published on 26 May 2021.
Please send any queries on this topic to devices@hpra.ie.