Order for reference for a preliminary ruling on the scope of verification duties of medical device distributors
On 21 December 2023, the German Federal Court of Justice (BGH) issued an order for referral to the ECJ for a preliminary ruling pursuant to Art. 267 (1) (b) TFEU. Five questions on the interpretation of the Medical Device Regulation (Regulation (EU) 2017/745, “MDR”) have been referred to the ECJ for answering.
Order for referral and questions submitted for a preliminary ruling
In terms of content, the order for referral by the BGH concerns the duties incumbent on distributors of medical devices in the light of Art. 14 MDR.
In a nutshell, the BGH requests answers to the following questions:
- Is a distributor obliged under Art. 14 (1), (2) subs. 1 (a) MDR to verify whether the product it has made available on the market is to be regarded as a medical device and therefore has been CE marked and whether the manufacturer has drawn up an EU declaration of conformity for a medical device?
- Does a distributor also have to verify whether the product falls under risk class IIa and must therefore have been given a four-digit identification number by a notified body?
- Is it relevant for the “reason to believe” that a product made available on the market by the distributor is not in conformity with the requirements of the MDR that the distributor becomes aware of such a legal evaluation through a competitor sending the distributor a warning letter?
- Does the answer to the last question depend, inter alia, on the distributor being informed by the manufacturer or an authority that the warning received is unfounded?
Tendency of the BGH
The ECJ has yet to answer the questions referred to it.
As soon as the ECJ has answered the questions, the BGH will in any case have to decide again. However, it is already clear which interpretation results the BGH is hoping to receive from the ECJ:
- The wording of Art. 14 MDR indeed does not require that the distributor’s verification duty within the meaning of the MDR is linked to the classification of the product as a medical device by the manufacturer. However, the distributor is only obliged to carry out verification within the scope and limits of its activities and only with due care; the proper marking is primarily the responsibility of the manufacturer.
- However, the meaning and purpose of Art. 14 MDR argue in favour of requiring the distributor to carry out a verification, irrespective of the fact that the product has been classified as a medical device by the manufacturer. This follows from the protective purposes of the MDR. Furthermore, the distributor has a key role according to the “Blue Guide”.
In this context, it is essential for distributors that, in the opinion of the BGH, the verification can also be carried out by examining the intended purpose of the documents provided (instructions for use, advertising and sales materials).
- The BGH further assumes that there is “reason to believe” within the meaning of Art. 14 MDR at the latest when a distributor becomes aware of a possible infringement through a warning letter from a competitor. This is because such “reason to believe” can cover any aspect that a reasonable distributor – acting with ordinary prudence and making reasonable efforts in consideration of the circumstances of the individual case to prevent harm to others – would consider as a reason to examine the question of product marking. In this case, notification to the manufacturer or an authority is not sufficient; making the product available on the market again is only permitted once conformity has been established. In this case, any obligation to pay damages to the manufacturer due to the failure to distribute the product is excluded.
- The BGH does not understand Art. 14 MDR – neither with regard to its wording nor with a view to the meaning and purpose of the provision – in such a way that it provides for a duty to verify whether a notified body must be and has been designated. In any case, the BGH considers the question to be open to interpretation because answering this question requires complex legal and factual considerations.
Conclusion
Art. 14 MDR for the first time provides a comprehensive legal framework governing the scope of duties of medical device distributors. A breach of these legal duties can give rise to liability claims by potentially injured product users or patients against the distributors themselves. It will be of essential importance for distributors how the ECJ will position itself in particular on the question of the duty to verify the risk class of the products specified by the manufacturer. If the existence of such a duty is affirmed, the scope of duties incumbent on distributors will expand significantly.
If you are an importer and / or distributor of medical devices and need support in identifying your legal duties and their limits, please do not hesitate to contact us. We will also be happy to assist you in drafting contracts with manufacturers, trading platforms and customers.
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