Regulatory Open Forum

Dear RAPS Members, 

GOV UK states in one of guidances: 

"Currently, under the UK MDR 2002, a CE marked device with a valid certificate is viewed as meeting the UKCA marking requirements whilst the CE marking continues to be recognised in Great Britain - depending on the type of device and legislation it complies with this is until 30 June 2030 at the latest. This includes devices placed on the market that:<o:p></o:p>

• were CE marked in accordance with the EU MDD or EU AIMDD (prior to 26 May 2021), or in accordance with the EU IVDD (prior to 26 May 2022);<o:p></o:p>
• are CE marked in accordance with the EU MDR or EU IVDR"

Does it mean that the devices can be marked with UKCA without incuding an UK notified body? Of course taking into account, that EU requirement are met as above. 

CE mark will be recognized only until December 2024. 

Thanks a lot.

Hello Anon

If your device is not ready yet for UKCA marking, but it does have the CE marking, then it is accepted in the UK. The guidance has been updated to show the extended dates for acceptance of CE marks:  https://www.gov.uk/guidance/regulating-medical-devices-in-the-uk  

As with CE-marking, some class I devices can be self-declared and UKCA-marked, if they conform to the UK regulations. There is no involvement of a UK Approved Body for those categories. For device categories that do require assessment by a UK Approved Body, the assessment is a prerequisite for UKCA marking.

------------------------------
Anne LeBlanc
United States

Original Message:
Sent: 06-Jul-2023 05:58
From: Anonymous Member
Subject: UKCA marking

This message was posted by a user wishing to remain anonymous

Dear RAPS Members, 

GOV UK states in one of guidances: 

"Currently, under the UK MDR 2002, a CE marked device with a valid certificate is viewed as meeting the UKCA marking requirements whilst the CE marking continues to be recognised in Great Britain - depending on the type of device and legislation it complies with this is until 30 June 2030 at the latest. This includes devices placed on the market that:<o:p></o:p>

• were CE marked in accordance with the EU MDD or EU AIMDD (prior to 26 May 2021), or in accordance with the EU IVDD (prior to 26 May 2022);<o:p></o:p>
• are CE marked in accordance with the EU MDR or EU IVDR"

Does it mean that the devices can be marked with UKCA without incuding an UK notified body? Of course taking into account, that EU requirement are met as above. 

CE mark will be recognized only until December 2024. 

Thanks a lot.

Hello Anne,

thanks a lot for your nice support.

So does this mean that UKCA labeling will become mandatory for MDD-approved devices until the certificate expires or June 30, 2028, whichever comes first (for MDR until June 2030) ?

Hello Anon

If your device is not ready yet for UKCA marking, but it does have the CE marking, then it is accepted in the UK. The guidance has been updated to show the extended dates for acceptance of CE marks:  https://www.gov.uk/guidance/regulating-medical-devices-in-the-uk  

As with CE-marking, some class I devices can be self-declared and UKCA-marked, if they conform to the UK regulations. There is no involvement of a UK Approved Body for those categories. For device categories that do require assessment by a UK Approved Body, the assessment is a prerequisite for UKCA marking.

Dear RAPS Members, 

GOV UK states in one of guidances: 

"Currently, under the UK MDR 2002, a CE marked device with a valid certificate is viewed as meeting the UKCA marking requirements whilst the CE marking continues to be recognised in Great Britain - depending on the type of device and legislation it complies with this is until 30 June 2030 at the latest. This includes devices placed on the market that:<o:p></o:p>

• were CE marked in accordance with the EU MDD or EU AIMDD (prior to 26 May 2021), or in accordance with the EU IVDD (prior to 26 May 2022);<o:p></o:p>
• are CE marked in accordance with the EU MDR or EU IVDR"

Does it mean that the devices can be marked with UKCA without incuding an UK notified body? Of course taking into account, that EU requirement are met as above. 

CE mark will be recognized only until December 2024. 

Thanks a lot.

Dear RAPS Members, 

GOV UK states in one of guidances: 

"Currently, under the UK MDR 2002, a CE marked device with a valid certificate is viewed as meeting the UKCA marking requirements whilst the CE marking continues to be recognised in Great Britain - depending on the type of device and legislation it complies with this is until 30 June 2030 at the latest. This includes devices placed on the market that:<o:p></o:p>

• were CE marked in accordance with the EU MDD or EU AIMDD (prior to 26 May 2021), or in accordance with the EU IVDD (prior to 26 May 2022);<o:p></o:p>
• are CE marked in accordance with the EU MDR or EU IVDR"

Does it mean that the devices can be marked with UKCA without incuding an UK notified body? Of course taking into account, that EU requirement are met as above. 

CE mark will be recognized only until December 2024. 

Thanks a lot.

Dear Anon,

The extract you cite from the MHRA website is stating that CE Marking is accepted in Great Britain, as meeting the UK's legislative requirements (for now). I.e., CE Marking is accepted as equivalent to UKCA Marking. But it does not mean that the device is UKCA marked and should bear UKCA marking. Those are still two separate processes.

If you have CE Marking and opt to register your device in Great Britain accordingly, this means that:

1. The device should be CE Marked only – it is not legal to add the UKCA marking symbol to the device unless it is appropriately UKCA marked.
2. The CE Marked device must still be registered with the MHRA. In the registration application, you will note:
1. The applicable legislation: EU Directive, EU Regulation, or UK MDR 2002, as applicable
2. Provide proof of conformity assessment: CE Marking certificate, EU Declaration of Conformity (self-certified devices), UKCA Marking Certificate, or UK Declaration of Conformity (self-certified devices), as applicable
3. Between now and the timeframe that CE Marking will no longer be recognized in Great Britain, companies must UKCA Mark the device.
1. As part of that, you will develop a UK tech file (citing UK legislation), add the UKCA symbol and UK Responsible Person's information (if applicable), obtain a UKCA Marking certificate from a UK Approved Body, if applicable, and sign a Declaration of Conformity citing UK legislation
2. At that time of having UKCA Marked the device, you will update your MHRA registration accordingly

Per the MHRA's guidance "Regulating Medical Devices in the UK", CE Marking will be accepted in the UK for the following time periods:

• MDR, IVDR, and IVDD CE Marked devices – 30 June 2030 or the CE certificate expires, whichever is sooner
• MDD and AIMDD CE Marked devices – 30 June 2028, or once the device no longer meets the requirement of being a 'legacy' device, whichever is sooner

You can UKCA mark your device earlier than the deadlines above. But as of today, most companies are continuing to register based on their CE Marking.

------------------------------
Sydney O'Connell
Director of Global Representation
www.casusconsulting.com
------------------------------

Original Message:
Sent: 06-Jul-2023 05:58
From: Anonymous Member
Subject: UKCA marking

This message was posted by a user wishing to remain anonymous

Dear RAPS Members, 

GOV UK states in one of guidances: 

"Currently, under the UK MDR 2002, a CE marked device with a valid certificate is viewed as meeting the UKCA marking requirements whilst the CE marking continues to be recognised in Great Britain - depending on the type of device and legislation it complies with this is until 30 June 2030 at the latest. This includes devices placed on the market that:<o:p></o:p>

• were CE marked in accordance with the EU MDD or EU AIMDD (prior to 26 May 2021), or in accordance with the EU IVDD (prior to 26 May 2022);<o:p></o:p>
• are CE marked in accordance with the EU MDR or EU IVDR"

Does it mean that the devices can be marked with UKCA without incuding an UK notified body? Of course taking into account, that EU requirement are met as above. 

CE mark will be recognized only until December 2024. 

Thanks a lot.

Dear Anon,

The extract you cite from the MHRA website is stating that CE Marking is accepted in Great Britain, as meeting the UK's legislative requirements (for now). I.e., CE Marking is accepted as equivalent to UKCA Marking. But it does not mean that the device is UKCA marked and should bear UKCA marking. Those are still two separate processes.

If you have CE Marking and opt to register your device in Great Britain accordingly, this means that:

1. The device should be CE Marked only – it is not legal to add the UKCA marking symbol to the device unless it is appropriately UKCA marked.
2. The CE Marked device must still be registered with the MHRA. In the registration application, you will note:
1. The applicable legislation: EU Directive, EU Regulation, or UK MDR 2002, as applicable
2. Provide proof of conformity assessment: CE Marking certificate, EU Declaration of Conformity (self-certified devices), UKCA Marking Certificate, or UK Declaration of Conformity (self-certified devices), as applicable
3. Between now and the timeframe that CE Marking will no longer be recognized in Great Britain, companies must UKCA Mark the device.
1. As part of that, you will develop a UK tech file (citing UK legislation), add the UKCA symbol and UK Responsible Person's information (if applicable), obtain a UKCA Marking certificate from a UK Approved Body, if applicable, and sign a Declaration of Conformity citing UK legislation
2. At that time of having UKCA Marked the device, you will update your MHRA registration accordingly

Per the MHRA's guidance "Regulating Medical Devices in the UK", CE Marking will be accepted in the UK for the following time periods:

• MDR, IVDR, and IVDD CE Marked devices – 30 June 2030 or the CE certificate expires, whichever is sooner
• MDD and AIMDD CE Marked devices – 30 June 2028, or once the device no longer meets the requirement of being a 'legacy' device, whichever is sooner

You can UKCA mark your device earlier than the deadlines above. But as of today, most companies are continuing to register based on their CE Marking.

------------------------------
Sydney O'Connell
Director of Global Representation
www.casusconsulting.com

Original Message:
Sent: 06-Jul-2023 05:58
From: Anonymous Member
Subject: UKCA marking

This message was posted by a user wishing to remain anonymous

Dear RAPS Members, 

GOV UK states in one of guidances: 

"Currently, under the UK MDR 2002, a CE marked device with a valid certificate is viewed as meeting the UKCA marking requirements whilst the CE marking continues to be recognised in Great Britain - depending on the type of device and legislation it complies with this is until 30 June 2030 at the latest. This includes devices placed on the market that:<o:p></o:p>

• were CE marked in accordance with the EU MDD or EU AIMDD (prior to 26 May 2021), or in accordance with the EU IVDD (prior to 26 May 2022);<o:p></o:p>
• are CE marked in accordance with the EU MDR or EU IVDR"

Does it mean that the devices can be marked with UKCA without incuding an UK notified body? Of course taking into account, that EU requirement are met as above. 

CE mark will be recognized only until December 2024. 

Thanks a lot.

Thank you Sydney for your valuable input!

Our devices are already registered with the MHRA via our UKRP. So the one uclear thing, was the UKCA marking. 

As long as UK recognizes CE legalislation and  therefore CE marked devices, continuing to register CE marking devices seems to be the best option for now. 

One more thing, the guidance von gov.uk https://www.gov.uk/guidance/using-the-ukca-marking made me confused in my understading as they wrote there "You can continue to use the CE marking and reversed epsilon marking on the GB market until 31 December 2024." 

Original Message:
Sent: 11-Jul-2023 16:49
From: Sydney O'Connell
Subject: UKCA marking

Dear Anon,

The extract you cite from the MHRA website is stating that CE Marking is accepted in Great Britain, as meeting the UK's legislative requirements (for now). I.e., CE Marking is accepted as equivalent to UKCA Marking. But it does not mean that the device is UKCA marked and should bear UKCA marking. Those are still two separate processes.

If you have CE Marking and opt to register your device in Great Britain accordingly, this means that:

1. The device should be CE Marked only – it is not legal to add the UKCA marking symbol to the device unless it is appropriately UKCA marked.
2. The CE Marked device must still be registered with the MHRA. In the registration application, you will note:
1. The applicable legislation: EU Directive, EU Regulation, or UK MDR 2002, as applicable
2. Provide proof of conformity assessment: CE Marking certificate, EU Declaration of Conformity (self-certified devices), UKCA Marking Certificate, or UK Declaration of Conformity (self-certified devices), as applicable
3. Between now and the timeframe that CE Marking will no longer be recognized in Great Britain, companies must UKCA Mark the device.
1. As part of that, you will develop a UK tech file (citing UK legislation), add the UKCA symbol and UK Responsible Person's information (if applicable), obtain a UKCA Marking certificate from a UK Approved Body, if applicable, and sign a Declaration of Conformity citing UK legislation
2. At that time of having UKCA Marked the device, you will update your MHRA registration accordingly

Per the MHRA's guidance "Regulating Medical Devices in the UK", CE Marking will be accepted in the UK for the following time periods:

• MDR, IVDR, and IVDD CE Marked devices – 30 June 2030 or the CE certificate expires, whichever is sooner
• MDD and AIMDD CE Marked devices – 30 June 2028, or once the device no longer meets the requirement of being a 'legacy' device, whichever is sooner

You can UKCA mark your device earlier than the deadlines above. But as of today, most companies are continuing to register based on their CE Marking.

------------------------------
Sydney O'Connell
Director of Global Representation
www.casusconsulting.com

Original Message:
Sent: 06-Jul-2023 05:58
From: Anonymous Member
Subject: UKCA marking

This message was posted by a user wishing to remain anonymous

Dear RAPS Members, 

GOV UK states in one of guidances: 

"Currently, under the UK MDR 2002, a CE marked device with a valid certificate is viewed as meeting the UKCA marking requirements whilst the CE marking continues to be recognised in Great Britain - depending on the type of device and legislation it complies with this is until 30 June 2030 at the latest. This includes devices placed on the market that:<o:p></o:p>

• were CE marked in accordance with the EU MDD or EU AIMDD (prior to 26 May 2021), or in accordance with the EU IVDD (prior to 26 May 2022);<o:p></o:p>
• are CE marked in accordance with the EU MDR or EU IVDR"

Does it mean that the devices can be marked with UKCA without incuding an UK notified body? Of course taking into account, that EU requirement are met as above. 

CE mark will be recognized only until December 2024. 

Thanks a lot.

Dear RAPS Members, 

GOV UK states in one of guidances: 

"Currently, under the UK MDR 2002, a CE marked device with a valid certificate is viewed as meeting the UKCA marking requirements whilst the CE marking continues to be recognised in Great Britain - depending on the type of device and legislation it complies with this is until 30 June 2030 at the latest. This includes devices placed on the market that:<o:p></o:p>

• were CE marked in accordance with the EU MDD or EU AIMDD (prior to 26 May 2021), or in accordance with the EU IVDD (prior to 26 May 2022);<o:p></o:p>
• are CE marked in accordance with the EU MDR or EU IVDR"

Does it mean that the devices can be marked with UKCA without incuding an UK notified body? Of course taking into account, that EU requirement are met as above. 

CE mark will be recognized only until December 2024. 

Thanks a lot.

Dear RAPS Members, 

GOV UK states in one of guidances: 

"Currently, under the UK MDR 2002, a CE marked device with a valid certificate is viewed as meeting the UKCA marking requirements whilst the CE marking continues to be recognised in Great Britain - depending on the type of device and legislation it complies with this is until 30 June 2030 at the latest. This includes devices placed on the market that:<o:p></o:p>

• were CE marked in accordance with the EU MDD or EU AIMDD (prior to 26 May 2021), or in accordance with the EU IVDD (prior to 26 May 2022);<o:p></o:p>
• are CE marked in accordance with the EU MDR or EU IVDR"

Does it mean that the devices can be marked with UKCA without incuding an UK notified body? Of course taking into account, that EU requirement are met as above. 

CE mark will be recognized only until December 2024. 

Thanks a lot.