MHRA Update – References
MHRA update – In April 2023, the MHRA released the referenced guidance which was updated primarily to reflect an intended extension to acceptance of CE marked medical devices on the Great Britain market beyond 30 June 2023.
This guidance has been updated with changes to:
‘Labelling requirements’
‘Registrations in Great Britain’
‘CE marking and Notified Bodies’
‘Regulation of medical devices in Northern Ireland’
‘Summary of key requirements for placing a device on the Great Britain market’
Regulating medical devices in the UK – GOV.UK (www.gov.uk)
MHRA Update – Our Thoughts
Usually, such guidance leads medical device companies to:
“Rest on their laurels”
And to put off making the necessary improvements that are not only:
A critical necessity for future regulatory requirements
But also:
Absolutely key to optimal business performance and efficiency.
Simon Hoffman, CEO and founder of Hoffman Healthcare Consultancy says on the matter:
“The Medical Device Regulation (2017/745) outlines what we should have been doing for years and represents a savvy risk-based approach to not just compliance but essential business practice, that most importantly always puts the patient first”.
These delays in compulsory implementation provide an excellent opportunity for companies to devise a longer-term and more achievable plan. This will ensure all policies, procedures and efficient and integrated practices are fully in place and implemented according to realistic timelines and available resources, rather than as a last minute last ditch attempt to essentially keep a company in business.
MHRA Update – How We Can Help
Hoffman Healthcare Consultancy have an enviable and proven track record in the implementation of Quality Management Systems, and hands-on authoring of Technical Files/Design History Files for all classes of medical devices in all global territories.
We will work directly with you to perform a precise and detailed Gap Analysis, in line with key global requirements such as ISO 13485, 21 CFR pt 820, MDSAP and MDR 2017/745 to ensure all areas of your business 100% comply. HHC will walk your entire manufacturing lifecycle through systematically, step by step, in doing this.
We will then provide hands-on support in the composition of a full and commercially viable remediation plan, which fits in fully with your business and available resources.
The recently released guidance ensures that realistic and achievable plans can be put in place and executed, without the need for panic or cutting corners.
Hoffman Healthcare Consultancy can provide everything that is required to succeed:
Policy and procedure authoring
Technical File/Design File authoring
Risk management plan authoring and execution
Product and process verification and validation (including automated V&V)
Clinical trial and evaluation consultancy
Everything you need.
Full training will of course be provided to ensure all processes and practices are fully integrated into efficient, company operations.
With a client list including AstraZeneca, Novartis, Qiagen, Global Access Diagnostics (the Gates Foundation) and countless others, Hoffman Healthcare Consultancy have both the reputation and the credentials to ensure you succeed.
Discover more at Hoffman Healthcare Consultancy Home
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Contact us to discuss your requirements
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