The EU’s MDD/IVDD and MDR/IVDR regulations, as well as Canadian Medical Devices regulations, require that legal medical device and IVD manufacturers contract with government accredited/recognized auditing organizations (AO) to perform conformity assessment procedures beginning 26 May 2020. These assessments include manufacturers’ quality management systems (QMS) and product-specific technical documentation for conformance to state-of-the-art safety and clinical performance requirements.
The objective of this White Paper is to provide information to manufacturers who intend to market medical devices in the European Union (EU) and/or Canada with guidance on identifying, selecting and approving accredited EU Notified Bodies in accordance with the regulatory requirements of current medical device directives, including:
- Medical Devices Directive 93/42/EEC (MDD)
- Active Implantable Medical Devices Directive 90/385/EEC (AIMD)
- In Vitro Diagnostic Medical Devices Directive 98/79/EC (IVDD)
- European Medical Device Regulation 2017/745 (MDR)
- European In Vitro Device Regulation 2017/746 (IVDR)
- Medical Device Single Audit Program (MDSAP)
As with any business partnership, selecting the right organization to serve as a manufacturer’s EU Notified Body and/or Canadian MDSAP assessment body is of significant strategic importance and should managed accordingly.
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