Just one further point to add to Ludger's comment: MHRA has stated that the UKRP should be designated from 1 January 2021. Even though formal identification of the UKRP may not be required until the time of device registration, in accordance with the classification-dependent timescale, should MHRA need to contact a non-UK manufacturer after 1 January 2021, they will expect to be able to do this via a UKRP, so companies need to act quickly to set up the appropriate agreements.
As it states on the
MHRA webpage providing guidance on what is expected after 1 January 2021:
"Manufacturers should aim to appoint their UK Responsible Persons as soon as possible".In addition, it makes sense for non-European manufacturers who have already designated an Authorized Representative (AR) to use the same organization to act as UKRP, if possible, to eliminate any duplication of effort in making technical documentation, etc., available. Many consultancies who specialize in AR services are setting up companies in the UK to offer parallel UKRP services, including my company,
Donawa Lifescience.
Under the currently drafted proposals, European manufacturers are allowed to continue to place CE marked devices on the UK market until 30 June 2023, but after this, they too will need to designate a UKRP.
Of course, all the above is based on a 'no deal' Brexit, but even if a deal is reached in the next few days, do not expect any significant changes.
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Roger Gray
VP Quality and Regulatory
Donawa Lifescience Consulting
Clinical Studies - Regulatory - Quality Systems
Rome, Italy
+39 06 578 2665
rgray@donawa.comwww.donawa.com------------------------------
Original Message:
Sent: 23-Oct-2020 06:19
From: Ludger Moeller
Subject: UK Authorized Representative Referrals?
Dear Susanne,
thank you for sharing this at RegEx.
MDSS-UK LTD is open for business as we prepare our clients for the UKRP requirements. However …
The requirements are not finalized. The guidance provided by the MHRA reflects nicely the DRAFT legislation. The draft law was published just a few days ago and still needs to go through the parliament.
A contract may be signed but can only go in effect in January. Up to December 31 the entity in the UK is still an EC REP and if there is another EC REP in the EU then this may be difficult.
I am pointing this out since I am seeing others are quite aggressively forthcoming pushing for it. I would be careful with that and someone should obtain full understanding of the requirements. A lot of costly mistakes can be made in the transition.
The UKRP should be installed as soon as possible according to the MHRA guidance and must be in place with the registration of products. It is the UKRP who must register the products. There is transition period installed for the registration staggered according to the risk class. With also being the EC REP we are able to coordinate the process and we work with our clients and mutual goal is to get everyone registered on time in the UK.
Here is the link to the MHRA guidance:
https://www.gov.uk/guidance/regulating-medical-devices-from-1-january-2021
And here is the direct link to the draft legislations:
https://www.legislation.gov.uk/ukdsi/2020/9780348213805/contents
And here is our offer:
https://mdssar.com/services/uk-responsible-person
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Ludger Moeller
President, MDSS GmbH
l.moeller@mdssar.com
Original Message:
Sent: 22-Oct-2020 08:38
From: Susanne Smith
Subject: UK Authorized Representative Referrals?
I have a small dental medical device client that wants to register in the UK and is seeking referrals for the "UK Responsible Person". Can anyone refer some names/representatives for me to share with my client so they can begin interviewing? Thanks very much for your assistance and you can contact me at STCSmith@aol.com.....or call my office at 941 460-8849 (EST) and leave me a message.....Thank You! Susanne
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Susanne Smith MSN
Biomedical Clinical and Regulatory Device Consultant
Englewood FL
United States
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