Medical Device Directive (MDD) vs. Medical Devices Regulation (MDR)
Article 120 Transitional Provisions
(1) From 26 May 2020, any publication of a notification in respect of a notified body in accordance with Directives 90/385/EEC and 93/42/EEC shall expire.
(2) Certificates issued by notified bodies in accordance with Directives 90/385/EEC and 93/42/EEC prior to 25 May 2019 shall remain valid until the end of the period indicated on the certificate. . . Certificates issued by notified bodies in accordance with Directives 90/385/EEC and 93/42/EEC from 25 May 2019 shall remain valid until the end of the period indicated on the certificate, which shall not exceed five years from its issuance. They shall, however, expire at the latest on 27 May 2024
(3) By way of derogation from Article 5 of this Regulation, a device with a certificate that was issued in accordance with Directive 90/385/EEC or Directive 93/42/EEC and which is valid by virtue of paragraph 2 of this Article may only be placed on the market or put into service provided that from the date of application of this Regulation it continues to comply with either of those Directives. . .
(4) Devices lawfully placed on the market pursuant to Directives 90/385/EEC and 93/42/EEC prior to 26 May 2020, and devices placed on the market from 26 May 2020 by virtue of a certificate as referred to in paragraph 2 of this Article, may continue to be made available on the market or put into service until 27 May 2025.
(5) By way of derogation from Directives 90/385/EEC and 93/42/EEC, devices which comply with this Regulation may be placed on the market prior to 26 May 2020.
Join us at DQS South Africa Training Center for a Q&A Session on Expectation, Requirements, and the steps needed to transition from MDD to MDR. Information related to MDSAP and CE Marking.
10:00 to 14:00 on 27 August 2019, Johannesburg DQS South Africa, Randburg
RSVP dqs@dqs.co.za or call 011 7870060
