Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

Hi All,

A little confusion on registration with MHRA for UK. If the manufacturer is outside the UK, do they still have to register as a manufacturer and appoint a  UK authorized rep? Or since the manufacturer is outside the UK, they only have to appoint/register a UK authorized rep?

Thanks for the help!

Things should be clearer by year end, but that's not a problem because you will be given plenty of time to register next year. 

------------------------------
Kevin Painter
Mentor, Medical Device Regulatory Compliance
Poland and United Kingdom
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Original Message:
Sent: 12-Nov-2020 16:52
From: Anonymous Member
Subject: UK Authorized Rep

This message was posted by a user wishing to remain anonymous

Hi All,

A little confusion on registration with MHRA for UK. If the manufacturer is outside the UK, do they still have to register as a manufacturer and appoint a  UK authorized rep? Or since the manufacturer is outside the UK, they only have to appoint/register a UK authorized rep?

Thanks for the help!

https://www.gov.uk/guidance/regulating-medical-devices-from-1-january-2021#responsible

------------------------------
Kevin Painter
Mentor, Medical Device Regulatory Compliance
Poland and United Kingdom
------------------------------

Original Message:
Sent: 13-Nov-2020 03:35
From: Kevin Painter
Subject: UK Authorized Rep

Things should be clearer by year end, but that's not a problem because you will be given plenty of time to register next year. 

From 1Jan. the term Authorised Representative will no longer be used within Great Britain, but your "UK Person Responsible" (new term) will register on your behalf. 

------------------------------
Kevin Painter
Mentor, Medical Device Regulatory Compliance
Poland and United Kingdom

Original Message:
Sent: 12-Nov-2020 16:52
From: Anonymous Member
Subject: UK Authorized Rep

This message was posted by a user wishing to remain anonymous

Hi All,

A little confusion on registration with MHRA for UK. If the manufacturer is outside the UK, do they still have to register as a manufacturer and appoint a  UK authorized rep? Or since the manufacturer is outside the UK, they only have to appoint/register a UK authorized rep?

Thanks for the help!

Good Morning....

Here is a link to the GOV.UK site that clearly states you CANNOT register if you are not in the UK.  Your authorized representative must register for you.

Register as a manufacturer to sell medical devices

GOV.UK		remove preview
Register as a manufacturer to sell medical devices If you place certain medical devices on the EU market you or your designated authorised representative must register with the competent authority (national health regulator) in the EU state where you have an office or place of business. In the UK, Medicines and Healthcare products Regulatory Agency (MHRA) is the competent authority for the registration of medical devices. View this on GOV.UK >

I hope this answers your questions,

Best regards,

------------------------------
D Michelle Williams
VP - Operations
United States
------------------------------

Original Message:
Sent: 12-Nov-2020 16:52
From: Anonymous Member
Subject: UK Authorized Rep

This message was posted by a user wishing to remain anonymous

Hi All,

A little confusion on registration with MHRA for UK. If the manufacturer is outside the UK, do they still have to register as a manufacturer and appoint a  UK authorized rep? Or since the manufacturer is outside the UK, they only have to appoint/register a UK authorized rep?

Thanks for the help!

Emergo by UL has finalized their UK Rep offering; if you need a UK Rep you can sign up now and they'll kick off the service next year.

------------------------------
Joshua Lust
Director of Quality Assurance & Regulatory Affairs
Caledonia MI
United States
------------------------------

Original Message:
Sent: 12-Nov-2020 16:52
From: Anonymous Member
Subject: UK Authorized Rep

This message was posted by a user wishing to remain anonymous

Hi All,

A little confusion on registration with MHRA for UK. If the manufacturer is outside the UK, do they still have to register as a manufacturer and appoint a  UK authorized rep? Or since the manufacturer is outside the UK, they only have to appoint/register a UK authorized rep?

Thanks for the help!

Dear Joshua,

Thank you for the information.  I felt compelled to respond to these posts.  MDSS as well offers the UK RP service.  The contract is ready but the following needs to be considered.

1. There is no law (yet). The proposal still has to go through the Parliament (https://www.legislation.gov.uk/ukdsi/2020/9780348214956/contents). Manufacturers indeed may sign the contract early on but certainly, it should contain carefully drafted provisions (see point 2).  Updates may need to be done once the law is finally in place.  
2. As you stated the UK RP can only be put in place at the earliest on January 1 due to the legal aspect that the EC REP is still a valid entity in the UK until then.  A manufacturer can not have two EC REP for the same products.  Your EC REP should guide you on this.
3. The databank for higher risk class devices is not in place.

The MHRA guidance clearly states to appoint the UK RP as soon as possible and they certainly mean after January 1 2021 (see point 2).

We have surveyed our clients and MDSS will be able to get its clients through the registration in due time as required by the MHRA.   

Here is the link to the updated guidance from Nov. 4:

https://www.gov.uk/guidance/regulating-medical-devices-from-1-january-2021


------------------------------
Ludger Moeller
President, MDSS GmbH
l.moeller@mdssar.com
------------------------------

Original Message:
Sent: 16-Nov-2020 08:49
From: Joshua Lust
Subject: UK Authorized Rep

Emergo by UL has finalized their UK Rep offering; if you need a UK Rep you can sign up now and they'll kick off the service next year.

------------------------------
Joshua Lust
Director of Quality Assurance & Regulatory Affairs
Caledonia MI
United States

Original Message:
Sent: 12-Nov-2020 16:52
From: Anonymous Member
Subject: UK Authorized Rep

This message was posted by a user wishing to remain anonymous

Hi All,

A little confusion on registration with MHRA for UK. If the manufacturer is outside the UK, do they still have to register as a manufacturer and appoint a  UK authorized rep? Or since the manufacturer is outside the UK, they only have to appoint/register a UK authorized rep?

Thanks for the help!

This confusion was brought to my attention by several manufacturers over the last week. In order not to confuse the wordings, I am discussing the registration that will become mandatory for manufacturers outside UK from January 1st 2021. These non-UK manufacturers need to appoint an UK RP (Responsible Person) who will register the manufacturer together with the devices that will be placed on the UK market. 
This is clearly described in the below process flow (source; MHRA). More info is available, https://www.qservegroup.com/eu/en/qserve-consulting-services/regulatory-affairs/local-representation/ukca---uk-responsible-person



------------------------------
martin.de.bruin@qservegroup.com
------------------------------

Original Message:
Sent: 12-Nov-2020 16:52
From: Anonymous Member
Subject: UK Authorized Rep

This message was posted by a user wishing to remain anonymous

Hi All,

A little confusion on registration with MHRA for UK. If the manufacturer is outside the UK, do they still have to register as a manufacturer and appoint a  UK authorized rep? Or since the manufacturer is outside the UK, they only have to appoint/register a UK authorized rep?

Thanks for the help!

This message was posted by a user wishing to remain anonymous

To add to this question, has anyone heard about about AR-ship for clinical trials in the UK in 2021? It is probably a safe assumption that the AR/UKRP must be UK based?

Thanks in advance.
Original Message:
Sent: 16-Nov-2020 10:49
From: Martin De Bruin
Subject: UK Authorized Rep

This confusion was brought to my attention by several manufacturers over the last week. In order not to confuse the wordings, I am discussing the registration that will become mandatory for manufacturers outside UK from January 1st 2021. These non-UK manufacturers need to appoint an UK RP (Responsible Person) who will register the manufacturer together with the devices that will be placed on the UK market.
This is clearly described in the below process flow (source; MHRA). More info is available, https://www.qservegroup.com/eu/en/qserve-consulting-services/regulatory-affairs/local-representation/ukca---uk-responsible-person

------------------------------
martin.de.bruin@qservegroup.com

Original Message:
Sent: 12-Nov-2020 16:52
From: Anonymous Member
Subject: UK Authorized Rep

This message was posted by a user wishing to remain anonymous

Hi All,

A little confusion on registration with MHRA for UK. If the manufacturer is outside the UK, do they still have to register as a manufacturer and appoint a  UK authorized rep? Or since the manufacturer is outside the UK, they only have to appoint/register a UK authorized rep?

Thanks for the help!