Newsletter July 2016
- EU: Revised Guidance on Clinical Evaluation – MEDDEV 2.7.1 (rev. 4)
- EU: MDR-Medical Device Regulation – consolidated text
- Germany: Regulation on unannounced audits
- Canada: Medical Device Single Audit Program (MDSAP) Transition Plan – FAQ issued
- Malaysia: Class A devices exempted from conformity assessment; some other devices from registration requirements