Annex III (EC Type – Examination) of Council Directive 93/42/EEC, a.k.a., the Medical Device Directive (MDD) delineates the requirements for having one’s head examined in the European Union (EU). In…
Annex III (EC Type – Examination) of Council Directive 93/42/EEC, a.k.a., the Medical Device Directive (MDD) delineates the requirements for having one’s head examined in the European Union (EU). In…
…II. The good news is that for device manufacturers that already comply with EN ISO 13485:2003, compliance with Annex II, from a quality system standpoint, is a proverbial “cake walk.”…
…II. The good news is that for device manufacturers that already comply with EN ISO 13485:2003, compliance with Annex II, from a quality system standpoint, is a proverbial “cake walk.”…
…commence this series of articles with the review and guidance for complying with Annex I of the MDD, “Essential Requirements.” Full text of MDD – 93/42/EEC ANNEX I – Essential…
…commence this series of articles with the review and guidance for complying with Annex I of the MDD, “Essential Requirements.” Full text of MDD – 93/42/EEC ANNEX I – Essential…
…the laws, regulations and administrative provisions necessary to comply with this Directive not later than 1 July 1994. They shall immediately inform the Commission thereof. The Standing Committee referred to…
…the laws, regulations and administrative provisions necessary to comply with this Directive not later than 1 July 1994. They shall immediately inform the Commission thereof. The Standing Committee referred to…
…will make it possible to invent new archetypes for the computer, coupled with new gestural and semantic languages. Our walls, tables and other elements in our environment may become platforms…
…will make it possible to invent new archetypes for the computer, coupled with new gestural and semantic languages. Our walls, tables and other elements in our environment may become platforms…
…than a device intended for clinical investigation, with a view to distribution and/or use on the Community market, regardless of whether it is new or fully refurbished; (i) “manufacturer” means…
…than a device intended for clinical investigation, with a view to distribution and/or use on the Community market, regardless of whether it is new or fully refurbished; (i) “manufacturer” means…
…a medical devices vigilance system. European Commission DG Enterprise and Industry. Retrieved February 26, 2011, from www.gtlaw.com/portalresource/lookup/wosid/contentpilot Vigilance Reports. (2011, February). Europa.en Website. Retrieved February 26, 2011, from http://ec.europa.eu/consumers/sectors/medical-devices/documents/vigilance-reports/index_en.htm …
…a medical devices vigilance system. European Commission DG Enterprise and Industry. Retrieved February 26, 2011, from www.gtlaw.com/portalresource/lookup/wosid/contentpilot Vigilance Reports. (2011, February). Europa.en Website. Retrieved February 26, 2011, from http://ec.europa.eu/consumers/sectors/medical-devices/documents/vigilance-reports/index_en.htm …
…prior to placing the device into commerce within the EU is also a violation of the Directive. Regardless, failing to comply with Article 18 of the Directive will have a…
…prior to placing the device into commerce within the EU is also a violation of the Directive. Regardless, failing to comply with Article 18 of the Directive will have a…
…by common accord, the time limits for completion of the assessment and verification operations referred to in Annexes II to VI. The notified body shall inform its competent authority about…
…by common accord, the time limits for completion of the assessment and verification operations referred to in Annexes II to VI. The notified body shall inform its competent authority about…
…of bad news, contrary to popular belief, so Dr. D will commence with the good news first. If a review by the applicable ethics committee, within a Member State(s), views…
…of bad news, contrary to popular belief, so Dr. D will commence with the good news first. If a review by the applicable ethics committee, within a Member State(s), views…
