Idea to Adoption: Part 10 Further Reading & Resources

CE MARKING AND UKCA MARKING GUIDANCE

https://www.ies.co.uk/hubfs/IES%20CE%20Marking%20&%20UKCA%20Marking%20Guide.pdf 

 

REGULATING MEDICAL DEVICES IN THE UK

https://www.gov.uk/guidance/regulating-medical-devices-in-the-uk 

 

THE MEDICAL DEVICES REGULATIONS (2002)

https://www.legislation.gov.uk/uksi/2002/618/contents/made 

 

DIRECTIVE 90/385/EEC - ACTIVE IMPLANTABLE MEDICAL DEVICES

https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A01990L0385-20071011 

 

DIRECTIVE 93/42/EEC - MEDICAL DEVICES

https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A01993L0042-20071011 

 

DIRECTIVE 98/79/EEC - IN VITRO DIAGNOSTIC MEDICAL DEVICES

https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A01998L0079-20120111 

 

GUIDANCE ON THE REGULATION OF IVD MEDICAL DEVICES IN GB

https://assets.publishing.service.gov.uk/media/67863a313ef063b15dca0f47/Guidance_on_the_regulation_of_IVD_medical_devices_in_GB.pdf 

 

APPLYING FOR A MANUFACTURER OF MEDICINES LICENSE

https://www.gov.uk/guidance/apply-for-manufacturer-or-wholesaler-of-medicines-licences 

 

REQUIREMENTS FOR SITE MASTER FILES

https://www.ies.co.uk/hubfs/IES%20CE%20Marking%20&%20UKCA%20Marking%20Guide.pdf

https://health.ec.europa.eu/document/download/95af86f8-c82d-4ad0-85cb-27c7f56531b4_en 

 

FDA MEDICAL DEVICE EXEMPTIONS

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/315.cfm 

 

FDA DEVICE REGISTRATION AND LISTING

https://www.fda.gov/medical-devices/how-study-and-market-your-device/device-registration-and-listing 

 

FDA GUIDANCE ON DESIGNATING A US AGENT

https://www.fda.gov/medical-devices/device-registration-and-listing/us-agents 

 

FDA INVESTIGATIONAL DEVICE EXEMPTIONS (IDE)

https://www.fda.gov/medical-devices/premarket-submissions-selecting-and-preparing-correct-submission/investigational-device-exemption-ide 

 

FDA QUALITY MANAGEMENT SYSTEM REGISTRATION (QMSR)

https://www.fda.gov/medical-devices/postmarket-requirements-devices/quality-management-system-regulation-qmsr 

 

FDA DEVICE LABELLING REQUIREMENTS

https://www.fda.gov/medical-devices/overview-device-regulation/device-labeling 

 

FDA MANDATORY REPORTING

https://www.fda.gov/medical-devices/postmarket-requirements-devices/mandatory-reporting-requirements-manufacturers-importers-and-device-user-facilities 

 

ISO COUNTRY CODES LIST

https://www.iso.org/obp/ui/#iso:pub:PUB500001:en 

 

ISO 13485:2016 MEDICAL DEVICES (PREVIEW)

https://www.iso.org/files/live/sites/isoorg/files/store/en/PUB100422_preview.pdf 

 

IEC 62304:2006 MEDICAL DEVICE SOFTWARE (PREVIEW)

https://www.iso.org/obp/ui/en/#iso:std:iec:62304:ed-1:v1:en 

 

ISO 15189:2022 MEDICAL LABORATORIES (PREVIEW)

https://www.iso.org/obp/ui/en/#iso:std:iso:15189:ed-4:v1:en 

 

ISO 22000:2018 FOOD SAFETY MANAGEMENT SYSTEMS (PREVIEW)

https://www.iso.org/files/live/sites/isoorg/files/store/en/PUB100454_preview.pdf 

 

ISO 26000 SOCIAL RESPONSIBILITY (FULL GUIDANCE)

https://www.iso.org/files/live/sites/isoorg/files/store/en/PUB100258.pdf 

 

ISO 31000:2018 RISK MANAGEMENT (PREVIEW)

https://www.iso.org/files/live/sites/isoorg/files/store/en/PUB100464_preview.pdf 

 

THE PATENTS ACT (1977)

https://assets.publishing.service.gov.uk/media/66fa4e32c71e42688b65ee3e/The-Patents-Act-1977-as-amended.pdf 

 

THE COPYRIGHT, DESIGNS & PATENTS ACT (1988)

https://assets.publishing.service.gov.uk/media/60180c2b8fa8f53fc62c5897/Copyright-designs-and-patents-act-1988.pdf 

 

IMPERIAL INTELLECTUAL PROPERTY POLICY

https://www.imperial.ac.uk/media/imperial-college/research-and-innovation/research-office/public/Intellectual-Property-Policy-ROP-07-Public-Access.pdf 

 

IMPERIAL RESEARCH PUBLICATIONS OPEN ACCESS POLICY

https://www.imperial.ac.uk/research-and-innovation/support-for-staff/scholarly-communication/open-access/oa-policy/ 

 

IMPERIAL GUIDELINES FOR PROPER SCIENTIFIC CONDUCT IN RESEARCH POLICY

https://www.imperial.ac.uk/research-and-innovation/research-office/research-policies/imperial-research-codes-of-practice/ 

 

IMPERIAL FINANCIAL REGULATIONS POLICY (RELATED TO IMPERIAL BRAND IDENTITY AND USAGE)

https://www.imperial.ac.uk/media-access/internal/?folder=administration-and-support-services/finance/internal&filename=Imperial-Financial-Regulations-Final-February-2024.pdf 

 

MARKET ACCESS IN GREAT BRITAIN

https://www.gov.uk/guidance/regulating-medical-devices-in-the-uk 

 

NICE FOR MARKET ACCESS TO THE NHS

https://www.nice.org.uk/what-nice-does/life-sciences-how-to-get-your-product-to-market 

https://www.nice.org.uk/what-nice-does/life-sciences-how-to-get-your-product-to-market/nice-advice-service/nice-advice-working-on-your-objectives#routes 

 

POST-MARKET SURVEILLANCE - EXCEPTIONAL USE AUTHORISATION

https://www.gov.uk/guidance/exceptional-use-authorisation 

 

Resource Download / Contact Us

You can download a copy of this section here: Idea to Adoption Part 10 (PDF)

If you would like to contact us, or if there is a resource you would like to see, reach out to us using this form!