Commentary: Except for an order change (f « g), there is essentially no change for what is considered a human tissue versus a medical device tissue product between the MDD and MDR. The text in the MDR provides clarification for the correct regulation/directive which needs to be followed.
The MDR corrigenda added that the transition deadline for both animal (f) and human tissue (g) medical device products, subject to the MDR, need to be in compliance by 26 May 2020. If not in compliance by the transition date, then yes the animal/human tissue medical devices would need to be removed from the market. However, viable human tissue products which are subject to Directive 2004/23/EC and not either the MDD or MDR are not impacted by this deadline.
MDD versus MDR Excerpts below:
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MDD
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MDR
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Article 120(10) - Transitional provisions
10. Devices falling within the scope of this Regulation in accordance with points (f) and (g) of Article 1(6) which have been legally placed on the market or put into service in accordance with the rules in force in the Member States prior to 26 May 2020 may continue to be placed on the market and put into service in the Member States concerned.
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Article 1
5. This Directive shall not apply to: ◄
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Article 1
6. This Regulation does not apply to:
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(f) transplants or tissues or cells of human origin nor to products incorporating or derived from tissues or cells of human origin, with the exception of devices referred to in paragraph 4a;
4 a. Where a device incorporates, as an integral part, a substance which, if used separately, may be considered to be a medicinal product constituent or a medicinal product derived from human blood or human plasma within the meaning of Article 1 of Directive
2001/83/EC
(1) and which is liable to act upon the human body with action ancillary to that of the device, hereinafter referred to as a 'human blood derivative',
that device shall be assessed and authorised in accordance with this Directive.
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(f) transplants, tissues or cells of animal origin, or their derivatives, or products containing or consisting of them; however this Regulation does apply to devices manufactured utilising tissues or cells of animal origin, or their derivatives, which are non-viable or are rendered non-viable;
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(g) transplants or tissues or cells of animal origin, unless a device is manufactured utilizing animal tissue which is rendered non-viable or non-viable products derived from animal tissue.
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(g) transplants, tissues or cells of human origin, or their derivatives, covered by Directive 2004/23/EC, or products containing or consisting of them; however this Regulation does apply to devices manufactured utilising derivatives of tissues or cells of human origin which are non-viable or are rendered non-viable;
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Let me know of I can be of further assistance.
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Sylvie Verdon; MS, RAC, MPM
Senior Consultant; REGSolutions, LLC
RAPS Atlanta Chapter Co-Chair
Alpharetta, GA USA
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Original Message:
Sent: 22-Mar-2019 20:16
From: Anonymous Member
Subject: MDR Corrigendum - Tissue Devices?
This message was posted by a user wishing to remain anonymous
Can anyone offer assistance in interpreting change 7 of the new MDR corrigenda? (English begins on p. 38.)
This change states:
On page 90, Article 120(10) for: "Devices falling within the scope of this Regulation in accordance with points (f) and (g) of Article 1(6) which …", read: "Devices falling within the scope of this Regulation in accordance with point (g) of Article 1(6) which …
And here are the relevant articles from MDR:
Article 120(10): "Devices falling within the scope of this Regulation in accordance with points (f) and (g) of Article 1(6) which have been legally placed on the market or put into service in accordance with the rules in force in the Member States prior to 26 May 2020 may continue to be placed on the market and put into service in the Member States concerned."
Article 1(6): This Regulation does not apply to: ...
(f) transplants, tissues or cells of animal origin, or their derivatives, or products containing or consisting of them; however this Regulation does apply to devices manufactured utilising tissues or cells of animal origin, or their derivatives, which are non-viable or are rendered non-viable;
(g) transplants, tissues or cells of human origin, or their derivatives, covered by Directive 2004/23/EC, or products containing or consisting of them; however this Regulation does apply to devices manufactured utilising derivatives of tissues or cells of human origin which are non-viable or are rendered non-viable;
This seems like it may mean that devices falling under 1(6)(f), e.g., made from non-viable tissue, that were previously CE marked under the MDD, will no longer be able to be marketed after May 26, 2020 unless they have transitioned to MDR. In other words, the availability of the soft transition has been removed for these devices.
Is this what's intended, or am I missing something here? I feel like I have to be misinterpreting it, as this would mean a large number of products - all bioprosthetic heart valves, just for starters - would cease to be available.