Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

Dear All,
What are the requirements for placing both UKCA symbol and Swiss Exit symbols in both CE marked devices as well as already submitted MDR applications. Do the latter have to have an MDF form submitted and approved by BSI prior to launching once MDR certification is received? Do the UK AR and Swiss ARs also have to be placed on the labels and IFUs? 
Best Regards!

Hello Anon,

Currently and more in the future, UKCA symbol/certification process (until new regulation is available), the European CE Marking process, and Switzerland requirements are all independent of each other.  Also not sure what you mean by a Swiss Exit symbol.  So if you are adding a UKCA symbol to the label after CE Marking, I would think you do not need a form since this has nothing to do with CE Marking.  Though you should confirm with your Notified Body and auditor because they like to often stretch their regulatory assessment outside of the scope of what they are supposed to be reviewing/auditing.  As far as the current requirements are: yes, you will have EU AR info, UK Resp Per info, and Swiss AR info.  So if you have limited space on your labelling this will sadly become a challenge.

Just make sure you carefully read the regulations for each of the areas because there are intricacies, as example the UK one currently: 'The name and address of the UK Responsible Person, where applicable, must be included on the product labelling or the outer packaging, or the instructions for use in cases where the UKCA marking has been affixed. UK Responsible Person details do not need to be included on labelling for CE marked devices, unless the device bears both the CE and UKCA markings.'  As in the last sentence, the UK Resp Per info does not need to be on current CE Marked device (till June 2023) unless you have the UKCA mark.

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Richard Vincins ASQ-CQA, MTOPRA, RAC
Vice President Global Regulatory Affairs
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Original Message:
Sent: 18-Apr-2022 06:45
From: Anonymous Member
Subject: UKCA and Swiss Exit symbol

This message was posted by a user wishing to remain anonymous

Dear All,
What are the requirements for placing both UKCA symbol and Swiss Exit symbols in both CE marked devices as well as already submitted MDR applications. Do the latter have to have an MDF form submitted and approved by BSI prior to launching once MDR certification is received? Do the UK AR and Swiss ARs also have to be placed on the labels and IFUs?
Best Regards!

To the anonymous questioner,

There are big differences between the UK and Switzerland approach. While the UK sets its own requirements for medical devices with the «UK MDR 2002» and therefore also requires its own conformity assessment mark, Switzerland fully recognizes the requirements of the EU. As the Swiss-EU Institutional agreement was not signed because of controversy between the EU and CH, Switzerland has become a third country in the medical devices sector, as the Bilateral Agreements I - Technical barriers to trade (Mutual Recognition Agreement–MRA) have not been updated to the requirements of MDR and IVDR.

Switzerland now unilaterally recognizes the requirements, which is also made clear in the Medical Device Ordinance SR 812.213, a CE-Mark still is required to place medical devices in the Swiss market. However, a CH-REP must now also be designated and registered, as Swissmedic – the market surveillance authority for medical devices – no longer has access to EUDAMED. The CH-REP does not necessarily have to be on the packaging itself if the manufacturers come from the EU, but it is sufficient to enclose this information. Attached is the corresponding information sheet from Swissmedic.

Regards

Margit

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Margit Widmann MD
Director Regulatory
Günsberg
Switzerland
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Original Message:
Sent: 18-Apr-2022 06:45
From: Anonymous Member
Subject: UKCA and Swiss Exit symbol

This message was posted by a user wishing to remain anonymous

Dear All,
What are the requirements for placing both UKCA symbol and Swiss Exit symbols in both CE marked devices as well as already submitted MDR applications. Do the latter have to have an MDF form submitted and approved by BSI prior to launching once MDR certification is received? Do the UK AR and Swiss ARs also have to be placed on the labels and IFUs?
Best Regards!