I agree with Cristoph in response to Anon's question: "I would assume for a class IIb (non-implantable), such a contract would not be required?"
MDR Article 61(5) applies only to those device classes specified in Article 61(4), i.e., implantable devices and class III devices. This was the subject of debate in the CIE meeting, resulting in specific sections in guidances MDCG 2020-5 and 2023-7, both of which clarify that Article 61(5) is very much dependent on classification.
MDCG 2020-5 states:
"For a manufacturer of implantable devices and class III devices claiming equivalence to an already marketed device not manufactured by him, in addition to the requirements in MDR Article 61(4), the manufacturer must have a contract in place that allows full access to the technical documentation on an ongoing basis," and
"For devices other than implantable devices and class III devices and where the manufacturer wants to claim equivalence, MDR Article 61 (3) is applicable."
Article 61(3) does not mention the need for a contract.
MDCG 2023-7 reinforces this clarification, stating:
"The beginning of the first sentence of Article 61(4) provides the general obligation, namely "in the case of implantable devices and class III devices, clinical investigations shall be performed". The remainder of Article 61(4), as well as Article 61(5) and 61(6) describe circumstances under which these devices are exempted from the requirement to conduct clinical investigations," and
"Article 61(5) states "a manufacturer […] may also rely on paragraph 4 in order not to perform a clinical investigation provided that the following conditions are fulfilled in addition to what is required in that paragraph". This indicates that the exemption case outlined in Article 61(5) is dependent on criteria described in Article 61(4) being met."
One of the criteria from Article 61(4) is clearly its application to only implantable devices and Class III devices.
Remember also that MDCG 2023-7 states: "Devices which are neither class III nor implantable are outside the scope of this document," so it is entirely inappropriate to try and use the appendices of this document for other than Class III and implantable devices.
So under the circumstances Anon describes, no contract is required under the MDR for his/her Class IIb non-implantable device.
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Roger Gray
VP Quality and Regulatory
Donawa Lifescience
Clinical Studies - Regulatory - Quality Systems
AR/UKRP services
Italy and UK
rgray@donawa.comwww.donawa.com------------------------------
Original Message:
Sent: 28-Apr-2024 15:35
From: Christoph Kiesselbach
Subject: Equivalence by testing
Hi Anon,
I think you are correct. While Article 61(5) itself does not adress classification, it is in reference to possible additional exceptions for the mandatory performance of clinical investigations for class III and implantable products from Article 61(4). Its application therefore only makes sense for those devices, and a class IIb non-implantable device would not be affected.
That said: I think the original question is misleading. If you already have decided that you do not have sufficient access to the data to decide on equivalence, then testing will not change this. You would need to argue that the combination of data access you have together with testing gives you sufficient access to information you can base your claim for equivalence on. This is independent of the actual evaluation of the data to prove equivalence.
While this is a theoretical possibility, i am not sure how much this helps, because testing gives you only data for a limited sample size (for the current design as well as with respect to possible changes of the evaluated device in the past). The possibility is mentioned in MDCG 2023-7 as Patricia stated, however the guidance does not really evaluate the different "hierarchy levels" proposed in Annex II of the guidance. Which level is sufficient still remains a matter for individual evaluation.
Best regards, Christoph
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Christoph Kiesselbach
Schrack & Partner
Reutlingen
Germany
Original Message:
Sent: 25-Apr-2024 19:15
From: Anonymous Member
Subject: Equivalence by testing
This message was posted by a user wishing to remain anonymous
Thanks for your responses, however I would assume for a class IIb (non-implantable) , such a contract would not be required?
Original Message:
Sent: 25-Apr-2024 03:29
From: Stephanie Grassmann
Subject: Equivalence by testing
Dear Anon
Please be aware that the equivalence definition under MDD is not the same as under MDR (see Annex XIV #3).
For instance: you will need full ongoing access to the Technical File of the equivalence device through a contract. The CER of the equivalent device also has to have been performed according to the MDR and the manufacturer of the equivalent device has to deliver proof to the NB to this point.
If the MDR regulatory requirements i.e. contract and ongoing access associated with equivalence cannot be fulfilled and proven to the NB then I would recommend not to go this route.
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Stephanie Grassmann
Founder & Managing Director of MedTechXperts Ltd
Biberstein
Switzerland
Original Message:
Sent: 21-Apr-2024 20:08
From: Anonymous Member
Subject: Equivalence by testing
This message was posted by a user wishing to remain anonymous
Hi,
Is it possible to claim equivalence under MDR to a competitor device for class IIb (non-implantable device) where we cannot have sufficient access; by testing for the technical and biological characteristics? Has anybody claimed equivalence using this approach and accepted by the notified body?
thanks