Author: Dr. Judit Balogh
Given that a significant part of medical devices are sold by public procurement procedure, on both the tenderer and contracting authority sides, the question often arises as to the impact of compliance with the MDR, in particular the issuance of a new certificate, on contracts concluded as a result of public procurement procedures.
During the last months, there were several inconsistent interpretations in connection with this issue, and this issue has created uncertainty on both the tenderer and contracting authority sides.
According to someone’s point of view a device with a new certificate should be considered as a new product, which means product replacement or new tender obligation, while others intend to treat the delivery of the product with a new certificate as a reason of contract amendment.
Contrary to the above, our Firm, in agreeing with many other market participants, simply considers the compliance with MDR as the compliance with legal requirement, which may affect public procurement contracts, but it does not justify the termination or amendment thereof.
In view of the above contradictions and different interpretations, our Firm requested the official opinion of the Public Procurement Authority.
The Authority – in its opinion – confirmed the interpretation of our Firm, according to which if the MDD certificate of a medical device expires under MDR and the new certificate will be issued under MDR, – if the other parameters of the product are unchanged (use, physical, – and technical characteristics) – the product replacement is conceptually excluded, i.e. this should not be treated as a product replacement.
In this context, the Authority explicitly stated that ‘it is not about switching from the delivery of products used during the fulfilment to the delivery of other products, but fulfilment also applies to the same products when the old certification expires and the new certification is obtained, therefore, the requirement of a product replacement – that the tenderer, for the reason of the contract, could only be replaced by another product for some reason instead of the product covered by the contract – is presumably not fulfilled, so that there can be no product replacement in the present case.’
However, the Authority emphasized that in the event of a change in any criteria set out above (product’s physical and technical parameters, purpose), it should be examined whether further procurement of products could be considered as a new procurement. However, this is logically not related to obtaining a new certificate, but to changing the parameters of the product.
Regarding the issue of contract amendment, the Authority also agreed our Firm’s point of view, according to which the new certificate does not result a contract amendment obligation, the issue of contract amendment depends primarily on any changes in the terms of the public procurement contract.
Thus, for example, if the contract has special provision on the existence of a certificate under MDD and the requirement for its validity, the delivery of products certified under MDR may, where appropriate, cause the contract amendment obligation.
However, if the product certificate becomes invalid during the fulfilment of the public procurement contract and thus the products need to be certified in accordance with the MDR, the fulfilment with the product with the new certificate does not result a contract amendment obligation either.
In our view, the Public Procurement Authority, with its individual official opinion to our Office, dispelled the interpretation anomalies presented in the introduction and confirmed our interpretation, that if the parameters of the product remain unchanged during the fulfilment of the contract and a new MDR certificate is issued for the product, the performance can be considered as contractual appropriate and the existence of the new certificate alone does not justify the application of the provisions on contract amendment or product replacement.
For the sake of clarity, we note that the individual official opinion of the Public Procurement Authority is not binding on a court or other authority and is for information only, intended to support the correct application of the law by the persons requesting the such official opinion and the preparation and conduct of lawful procurement procedures.
The information above possesses exclusively informative nature, for further details we kindly ask you to contact our Firm.
[1] Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC
[2] Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
