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The Medical Device Directive 93/42 EEC as Amended by 2007/47 EC—Are you Ready?
Manufacturers must be in full compliance with the changes that apply to them by March 21, 2010.
Changes to the Directive include, but are not limited to:
- Re-Classification of some devices that impact the central circulatory system
- Record retention
- Increased emphasis on clinical data (required for all devices, regardless of EU classification)
- Software classification
- Conformity assessment options-class I manufacturers may choose Annex II
- More in depth review of technical documentation by Notified Bodies
- Usability/ergonomics per EN 62366
- Overlap with Machinery Directive 2006/42 EC
It is critical that each manufacturer review 2007/47 as well as related guidance documents to determine what changes are applicable and the impact of the changes. Reviews should be documented and with justification for those requirements deemed not applicable.
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AdvQSS Client Serv ices
ADVQSS will work with you to address all of your needs including the following:
- Quality system development and compliance
- 21 CFR Part 820 (FDA)
- EN ISO 13485:2003
- Canadian Medical Devices Regulation (CMDCAS)
- 93/42 EEC Medical Device Directive as amended by 2007/47
- 98/79/EEC, In-Vitro Diagnostic Directive
- 90/385/EEC, Active Implantable Medical Devices Directive
- Japan PAL (Pharmaceutical Affairs Law)
- Improvements to existing quality systems
- FDA Warning Letters and 483 responses
- Adverse event reporting and product recalls
- 3rd party Notified Body/quality system registrar corrective action plans
- Quality system audits and gap analyses
- 2nd party supplier audits
- Technical documentation required for CE Marking
- 510(k)s and Canadian medical device license applications
- On-site training specific to client needs (CAPA, complaints, risk management, auditing, etc.)
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