This message was posted by a user wishing to remain anonymous
This is odd. A year ago the European Commission had proposed that SQS MDD certificates should remain valid, to keep those devices on the market, while SQS would not be eligible for MDR.
The SQS website still shows that they believe they are accredited for MDD. (https://www.sqs.ch/en/about-us/accreditation)
The Swissmedic website still shows that they believe SQS is accredited for MDD. (Information sheet - Procurement of medical devices in healthcare institutions)
But at some point SQS/MDD got deleted from the NANDO database. (https://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=notifiedbody.notifiedbody&refe_cd=EPOS%5F49878&version_no=10)
Original Message:
Sent: 20-Jul-2022 03:44
From: Valentina Faziani
Subject: Notified Body SQS (CE 1250) from switzerland is not longer a Notified Body for UK
Hi Adrian,
I've just tried to make a research but I couldn't find any precise information about. Could be please provide a link to this news so that I can try to help you?
Thank you
Regards
------------------------------
Valentina Faziani
Regulatory Affairs Specialist
Thema s.r.l.
Italy
Original Message:
Sent: 19-Jul-2022 03:17
From: Adrian Gammeter
Subject: Notified Body SQS (CE 1250) from switzerland is not longer a Notified Body for UK
I have just learned that in the UK the Swiss Notified Body SQS (CE 1250) certificates are no longer recognized and the registered products may no longer be placed to the UK market. Also, the UK Authorised Representative (UKRP) registrations and manufacturer registration with SQS (CE 1250) have been canceled (unregistered).
MHRA wrote: MHRA has removed and therefore unregistered the device/s.
MHRA comment: Incorrect Notified Body certification,Other : notified body ce1250 from switzerland is not longer a Notified Body so their certificates regardless when issued are no longer valid. MHRA cannot accept registration unless the notified body is still valid in EU.
It appears that there is a disagreement (about the Mutual Recognition Agreement) between the Swiss/EU/UK authorities and whether the certificates from SQS remain valid and until the situation is clearer, SQS certificates are not recognized by MHRA. Negotiations are apparently underway on this matter, although it does seem to be a confusing situation.
And further the past decisions on MD classification (MDD) of switzerland competent authority are no longer recognized by MHRA: Swissmedic are no longer considered a competent authority for ce marking and MHRA is entitled to have our own classification view.
Are there other similar challanges relating to Swiss/EU/UK authorities disagreement and Swiss Notified Body SQS (CE 1250) MDD-CE-Certificates?
------------------------------
Adrian Gammeter
senior consultant
Oberkirch
Switzerland
------------------------------