EMDT_European Medical Device Technology

European Medical Device Technology, Summer 2015

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emdt.co.uk European Medical Device Technology Summer 2015 | 15 Regulators Forum (IMDRF), established in October 2011. The IMDRF includes representatives from the medical device regulatory authorities of Australia, Brazil, Canada, China, European Union, Japan, and the United States, as well as the World Health Organization (WHO). On Decem- ber 2013, the IMDRF issued final guidance titled "UDI Guidance Unique Device Identi- fication (UDI) of Medical Devices." In the meantime, in April 2013, the European Commission issued a Com- mission Recommendation on a common framework for a unique device identifica- tion system of medical devices in the Union (2013/172/EU) The recommendation refers to the inclusion of traceability requirements in the European proposed regulations for medical devices. Perils of Waiting Until the Last Minute Manufacturers intending to export their medical devices to the United States need to identify the deadlines for complying with U.S. UDI requirements that apply to their devices. Regardless of the size of the organi- zation and the number and range of devices involved, the work needed to understand the new requirements and comply with them will involve considerable time, invest- ment and resources. New procedures will undoubtedly need to be developed and existing procedures modified, all managed and documented under the quality system change control program. Furthermore, per- sonnel will need to be trained on the new and modified procedures while verification and validation activities will need to be per- formed. These activities will require input from a number of departments, including design and development, purchasing, qual- ity control, manufacturing and packaging, and, certainly, quality assurance. Prudent companies will plan well in advance for successful compliance with U.S. UDI requirements to avoid costly mistakes that can easily occur when such a complex and multidisciplinary activity is unduly rushed. References 1. FDA website on the benefits of a UDI system: www.fda.gov/MedicalDevices/ DeviceRegulationandGuidance/ UniqueDeviceIdentification/ BenefitsofaUDIsystem/default.htm 2. FDA Unique Device Identification System Final Rule, 24 September 2013: www.federalregister.gov/ articles/2013/09/24/2013-23059/unique- device-identification-system 3. FDA Unique Device Identification System: Small Entity Compliance Guide, 13 August 2014: www.fda. gov/downloads/MedicalDevices/ DeviceRegulationandGuidance/ GuidanceDocuments/UCM409401.pdf 4. List of UDI issuing agencies authorized by FDA: www.fda.gov/MedicalDevices/ DeviceRegulationandGuidance/ UniqueDeviceIdentification/ UDIIssuingAgencies/default.htm 5. Commission Recommendation of 5 April 2013 (2013/172/EU): http://eur-lex.europa.eu/ legal-content/EN/TXT/?qid=1429515903657 &uri=CELEX:32013H0172 6. European Commission website on the proposed medical device regulations: http://ec.europa.eu/growth/sectors/medical- devices/documents/revision/index_en.htm Innovative solutions engineered to your specifc requirements. Realize your vision with the most experienced and dedicated team in the industry. MicroLumen.com

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