Regulatory Open Forum

Dear Community,

The recognition of UK approved bodies takes a while and one of the auditing organization I work with is not yet approved for issuing certificates under UK MDR.
My understanding of the UK MDR self certification process is that Class I devices can be self-certified completely without involvment of an approved body. This means we could claim UK MDR compliance and issue a UK MDR DoC even if the QMS had not yet been audited and certified by the approved body against UK MDR.
The QMS would be be UK MDR ready of course and the device (e.g. labelling) and technical documentation would also meet the UK requirements. 

Would you agree with my interpretation ? Or is there a requirement I am missing?

Kind regards,
Michael

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Michael Hottner
Köln
Germany
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Hello Michael,

I think your interpretation is correct. You can have a look at this detailed guidance on self-registration process if you have not see it yet - https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/1058009/Device_Registration_Reference_Guide_March_2022_-_Final_v1__1_.pdf

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Good luck!

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Olga Peycheva
Regulatory and Study Start Up Specialist
United Kingdom
------------------------------

Original Message:
Sent: 14-Nov-2022 06:29
From: Michael Hottner
Subject: Self Certification under UK MDR and approved bodies

Dear Community,

The recognition of UK approved bodies takes a while and one of the auditing organization I work with is not yet approved for issuing certificates under UK MDR.
My understanding of the UK MDR self certification process is that Class I devices can be self-certified completely without involvment of an approved body. This means we could claim UK MDR compliance and issue a UK MDR DoC even if the QMS had not yet been audited and certified by the approved body against UK MDR.
The QMS would be be UK MDR ready of course and the device (e.g. labelling) and technical documentation would also meet the UK requirements.

Would you agree with my interpretation ? Or is there a requirement I am missing?

Kind regards,
Michael

------------------------------
Michael Hottner
Köln
Germany
------------------------------

Michael, if you have your medical device is Class I then yes you can self-certify, just as you could under the MDD and now with the MDR.

When you self-certify, it is not just your QMS and labelling that needs to address the UK MDR 2002 (as amended) but also your technical documentation that supports the signed DoC, which is where it gets a bit messier as you are supposed to (although time will tell how much this enforced) include references to UK legislation and standards rather than the EU equivalents. There is a comparison table available, although unfortunately I cannot locate it at the moment. It is trickier for standards as the theory is that the standards harmonised to the Directives (i.e. the UK MDR 2002 too) are key, although now many of those have been superseded with a new (state of the art) standard. I would advocate applying the latest/current version of said standards, whilst also considering what was written in the Annex Z tables of the previous harmonised versions.

------------------------------
Edward Ball
Manager, Intelligence & Innovation
United Kingdom
------------------------------

Original Message:
Sent: 14-Nov-2022 06:29
From: Michael Hottner
Subject: Self Certification under UK MDR and approved bodies

Dear Community,

The recognition of UK approved bodies takes a while and one of the auditing organization I work with is not yet approved for issuing certificates under UK MDR.
My understanding of the UK MDR self certification process is that Class I devices can be self-certified completely without involvment of an approved body. This means we could claim UK MDR compliance and issue a UK MDR DoC even if the QMS had not yet been audited and certified by the approved body against UK MDR.
The QMS would be be UK MDR ready of course and the device (e.g. labelling) and technical documentation would also meet the UK requirements.

Would you agree with my interpretation ? Or is there a requirement I am missing?

Kind regards,
Michael

------------------------------
Michael Hottner
Köln
Germany
------------------------------

Hello,

also important to mention is that MHRA delayed the implementation to Summer 2024. So only by then a NB will be required

------------------------------
Franky Dubois
QA/RA Manager
Gent
Belgium
------------------------------

Original Message:
Sent: 14-Nov-2022 06:29
From: Michael Hottner
Subject: Self Certification under UK MDR and approved bodies

Dear Community,

The recognition of UK approved bodies takes a while and one of the auditing organization I work with is not yet approved for issuing certificates under UK MDR.
My understanding of the UK MDR self certification process is that Class I devices can be self-certified completely without involvment of an approved body. This means we could claim UK MDR compliance and issue a UK MDR DoC even if the QMS had not yet been audited and certified by the approved body against UK MDR.
The QMS would be be UK MDR ready of course and the device (e.g. labelling) and technical documentation would also meet the UK requirements.

Would you agree with my interpretation ? Or is there a requirement I am missing?

Kind regards,
Michael

------------------------------
Michael Hottner
Köln
Germany
------------------------------

Original Message:
Sent: 11/14/2022 6:29:00 AM
From: Michael Hottner
Subject: Self Certification under UK MDR and approved bodies

Dear Community,

The recognition of UK approved bodies takes a while and one of the auditing organization I work with is not yet approved for issuing certificates under UK MDR.
My understanding of the UK MDR self certification process is that Class I devices can be self-certified completely without involvment of an approved body. This means we could claim UK MDR compliance and issue a UK MDR DoC even if the QMS had not yet been audited and certified by the approved body against UK MDR.
The QMS would be be UK MDR ready of course and the device (e.g. labelling) and technical documentation would also meet the UK requirements. 

Would you agree with my interpretation ? Or is there a requirement I am missing?

Kind regards,
Michael

------------------------------
Michael Hottner
Köln
Germany
------------------------------

Agreed, for all devices placed on the UK market, they must be registered with the MHRA (online registration) and for manufacturers based outside of the UK there must also be a UK Responsible Person (like a EU Authorised Rep), whose details will be included on the registration entries. If you self-declare for UKCA, then the requirements to identify the UKRP on your product and/or labelling etc is introduced immediately. The 2024 date is only for the end of the standstill period, after which CE marked devices will no longer be accepted. The June 2024 date is not official yet (although has been publicly announced), until such time as the legislation is amended.

------------------------------
Edward Ball
Manager, Intelligence & Innovation
United Kingdom
------------------------------

Original Message:
Sent: 15-Nov-2022 07:11
From: D Michelle Williams
Subject: Self Certification under UK MDR and approved bodies

Dear Michael,

 

It is my understanding that you must have a UKRP which is essentially an approved body.  Our customers in the UK have asked to see our registration papers prior to shipment.  While we are self-declaring just as we do in the EU we still have an Authorized Representative in both areas.

 

Best regards,

Michelle

 

D. Michelle Williams, CESCO

VP – Operations

 

Action Products, Inc.

www.actionproducts.com

301.797.1414 X1022

 

https://www.linkedin.com/in/dmwilliamsvpopapiwvu88

 

 

 

Original Message:
Sent: 11/14/2022 6:29:00 AM
From: Michael Hottner
Subject: Self Certification under UK MDR and approved bodies

Dear Community,

The recognition of UK approved bodies takes a while and one of the auditing organization I work with is not yet approved for issuing certificates under UK MDR.
My understanding of the UK MDR self certification process is that Class I devices can be self-certified completely without involvment of an approved body. This means we could claim UK MDR compliance and issue a UK MDR DoC even if the QMS had not yet been audited and certified by the approved body against UK MDR.
The QMS would be be UK MDR ready of course and the device (e.g. labelling) and technical documentation would also meet the UK requirements.

Would you agree with my interpretation ? Or is there a requirement I am missing?

Kind regards,
Michael

------------------------------
Michael Hottner
Köln
Germany
------------------------------