Hello Anon,
There was no exemption because there was no previous CE Marking of medical devices, so all devices went through the same five (5) year transition period (2 years transposing into national law + 3 years for transition). There was no "grace" period like there is under Article 120, though there was an additional 3 years (out to 2001) for product already "placed into service" meaning in inventory at distributors (which the company I worked for back then we took advantage of). When the compliance date in 1998 was reached, it was expected all medical devices were CE Marked according to the proper conformity assessment, which meant many Class I devices were self-declared. Move forward into 2017 with publication of the EU MDR, we know have a requirement for Competent Authorities called Market Surveillance. Under the EU MDD there was not much oversight, even sometimes zero oversight, of self-declare devices, which now should be different under the EU MDR.
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Richard Vincins RAC
Vice President Global Regulatory Affairs
Oriel STAT A MATRIX - ENTERPRISE
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Original Message:
Sent: 18-May-2021 11:11
From: Kevin Randall
Subject: Were Class 1 Devices "Grandfathered" when MDD took effect?
The MDD was adopted 14 June 1993. It became applicable 1 January 1995. Through 14 June 1998 devices were allowed to be placed on the market and put into service either in accordance with the new (at the time) MDD, or in accordance with the existing territorial rules that were in force prior to the MDD. These transitional provisions applied equally without regard to risk class; I don't recall any exemptions for Class I devices.
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Kevin Randall, ASQ CQA, RAC (Europe, U.S., Canada)
Principal Consultant
Ridgway, CO
United States
© Copyright 2021 by ComplianceAcuity, Inc. All rights reserved.
Original Message:
Sent: 18-May-2021 09:14
From: Anonymous Member
Subject: Were Class 1 Devices "Grandfathered" when MDD took effect?
This message was posted by a user wishing to remain anonymous
Hello, RAPS Community,
I am curious if anyone remembers when the Medical Device Directive first became effective and if, at that time, Class I devices which were already on the EU market were exempted from any of the requirements.
Thank you!