LONDON, Dec. 17 -- The government of the United Kingdom issued the following news:
Patients across England, Wales and Scotland couldbenefitfrom updated guidance on the Health Institution Exemption published today (17 December) by the Medicines and Healthcare products Regulatory Agency (MHRA).
This will supporthospitalsand other healthinstitutionstomanufacture new devices,ormodifyexisting devices,to meet specific clinical needsfortheir ownpatients- fromspecialist software that supports precise drug dosing tocommunication aidsdesigned tohelppatientswith a communication impairment.
Theupdatedleadingpracticeguidelineswillprovidehealth institutions clearer direction onwhen andhow theHealth Institution Exemptioncan be applied in practice.This aligns with theUK government's missions, including the10 Year Health Plan for Englandand the Life Sciences Sector Plan,and their focus on the role of technology in healthservices.
The update follows arecentsurvey of health institutionsandsets out five core principlesthattheyshould follow:maintainingquality management systems, ensuring device traceability, meetingtheessentialrequirements, keeping technical documentation, andongoingmonitoringofhow devices perform.The guidancealso includes practical, everyday scenariosto help medicalphysicists,clinical engineers and otherhealthcare professionals understand when the Health Institution Exemption applies.
The guidancealso provides examples to clarifythe types of organisations that may fall within scope, and those that do not, such as gyms,spasand fitness centres. It explains expectations where manufacturing activities are carried out on behalf of a health institution by a thirdparty,andsimplifies the use of key terms to reduce the risk of misunderstandingandensureconsistent application.
Health institutions are encouraged to check whethersuitable products are already availablebefore developing their own. Where they do create a device, theyshouldfollowappropriate qualityprocesses, keep clear records, and inform patients when a device has been made under the exemption.The updated guidance applies to general medical devices only and does not extend toin vitro diagnostic devices (IVDs).Importantly, anysafety concernsshould be reported through the MHRAYellow Card scheme.
Notes to editors
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The full guidance can be accessed here:Health Institution Exemption for general medical devices - GOV.UK. This guidancereplaces thepreviousguidance on in-house manufacture of medical devices in Great Britain.The Health Institution Exemption only applies when devices stay within the health institution that made them.Custom-made devices - such as custom wheelchairs or prosthetic appliances - must follow separatecustom-made deviceregulations. Health institutions in Northern Ireland should refer to separate EU-aligned guidance.
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The Medicines and Healthcare products Regulatory Agency (MHRA)is responsible forregulating all medicines and medical devices in the UK by ensuring they work and are acceptably safe. All our work is underpinned by robust and fact-based judgements to ensure that the benefits justify any risks.
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The MHRA is an executive agency of the Department of Health and Social Care.
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For mediaenquiries, please contact thenewscentre@mhra.gov.uk, or call on020 3080 7651.
Disclaimer: Curated by HT Syndication.
