Articles
UKCA Marking Update: Article Series
UK medical device regulatory changes
The recently published ”Government response to consultation on the future regulation of medical devices in the United Kingdom” has given us some insight into the UK Government’s intentions for the new UK Regulatory Framework due to be released in 2023.
We continue our summary of sections from the UK Government’s response with a look at the impact the intended changes to Post-market Surveillance, Vigilance and Market Surveillance.
This is the fifth part in a planned series of summarised elements from the aforementioned 155 page publication.
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UK medical device regulatory changes
We continue our summary of sections from the UK Government’s response to consultation on the future regulation of medical devices in the United Kingdom, with a look at Software as a Medical Device.
This is the fourth part in a planned series of summarised elements from the aforementioned 155 page publication.
Read more ...
UK medical device regulatory changes
The recently published ”Government response to consultation on the future regulation of medical devices in the United Kingdom” has given us some insight into the UK Government’s intentions for the new UK Regulatory Framework due to be released in 2023.
We continue our summary of sections from the UK Government’s response with a look at the impact on various Economic Operators: manufacturers, importers and distributors, UK responsible persons, and health institutions.
This is the third part in a planned series of summarised elements from the aforementioned 155 page publication.
Read more ...
UK medical device regulatory changes
The recently published ”Government response to consultation on the future regulation of medical devices in the United Kingdom” has given us some insight into the UK Government’s intentions for the new UK Regulatory Framework due to be released in 2023.
We continue our series of summarised elements from the aforementioned publication with a look at stated intentions in the important area of device Classification which dictates the level of regulation that covers particular devices.
This is the second part in a planned series of summarised elements from the aforementioned 155 page publication.
Read more ...
UK medical device regulatory changes
The recently published ”Government response to consultation on the future regulation of medical devices in the United Kingdom” has given us some insight into the UK Government’s intentions for the new UK Regulatory Framework due to be released in 2023.
What is changing?
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A phased approach to transitional arrangements has been signalled with the conformity deadline of 1 Jul 2023 being extended under certain conditions as detailed below.
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Closer alignment with EU MDR / IVDR (2017) requirements in certain areas with some UK specific requirements.
What is not changing?
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Current requirement that manufacturers and devices must be registered with the MHRA.
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Current requirements for manufacturers from outside the UK to appoint a UK Responsible Person.
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Urgency in preparation for the forthcoming regulatory changes to avoid delays and market barriers. This includes changes from EU MDD / IVDD to MDR / IVDR which will provide a better transitional arrangement under the UK regulations.
This is the first part in a planned series of summarised elements from the aforementioned 155 page publication.
News
Find the Summary of Safety and Performance Guide MDCG 2022-9 SSP in the PDF attached, or click here.
Regulation (EU) 2017/746 on in vitro diagnostic medical devices (the IVDR) requires that the manufacturer draw up a Summary of Safety and Performance (SSP) for class C and D IVD devices.
This SSP is intended to provide public access to an up-to-date summary of the main aspects of the safety and performance of the device. The SSP should be validated by the manufacturer’s Notified Body (NB) and made available to the public via the European database on medical devices (EUDAMED).
This guidance document has been endorsed by the Medical Device Coordination Group (MDCG) and sets out what should be included in the contents of an SSP. In particular, it should include information dedicated to the intended user, and if relevant, the patient. The SSP must be kept updated in EUDAMED via the manufacturer’s NB. If the device is not intended for self-testing, the SSP should have a first part dedicated to the professional user.
When relevant, a second part dedicated to patients/lay persons written in easily understandable language should be added. If the device is intended for self-testing, the SSP should be written in a way that is clear to the intended population of patients or lay persons who will use the device, for instance taking into consideration the age of the targeted population, etc.
View our library for find the MDCG website.
The new EU IVD Regulations (IVDR 2017/746) was formally published in May 2017 and comes into full force from 26 May 2022. The IVDR consolidates and replaces the IVD Directive (MDD) 93/79/EC and is a significant change for the industry. Currently the majority of IVDs do not require Notified Body involvement but under the new IVDR this will change so that most Invitro Diagnostic Devices will require notified body involvement. BSI and LRQA estimate that the re-classification of IVDs will mean 80-90% will no longer be able to self-certify conformity.
The new EU Medical Device Regulations (MDR 2017/745) was formally published in May 2017 and comes into full force from 26 May 2021. The MDR consolidates and replaces the Medical Devices Directive (MDD) 93/42/EE and the Active Implantable Medical Devices Directive (AIMDD) 90/385/EEC and is more strictly implemented, complex and comprises of 175 pages. There is no grandfathering of devices which means all existing devices will need to be assessed against the MDR and current standards and state of the art.
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