…the Community. In the light of the findings of this report, the Commission shall submit to the European Parliament and to the Council any additional proposal it may deem appropriate…

…such as “EC type-examination,” “EC declaration of conformity,” and “EC verification,” along with the importance of Annex II through Annex VIII. In simplifying the MDD requirement, Dr. D recommends committing…

…on 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…

…on 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…

…exposed to Dr. D’s diatribes in regards to compliance with harmonized standards. Yes, compliance to the standards is not mandated by law; however, it is important that harmonized standards appropriate…

…in compliance with the MDD. Additionally, devices in this category should never have a CE mark affixed. An example of devices falling into this category would be demonstration units being…

…maintain essential requirements can be viewed as risk mitigation. That said, Article 3 of the Directive invokes the need to comply with the following salient components. I strongly suggest that…

…comply with this Directive. Additionally, there is no mention of partial compliance, exclusion from compliance, maximum compliance, or similar nonsensical clauses associated with Article 2. If you really want to…