Interpretation of Article 16 (2b) - Packaging, samples and Certificate

[Asuka23741082402]

Hi,

Does anyone have an idea how to interpret Art. 16?

1) Regarding Art. 16 (2b): What packaging is meant here? Outer packaging seems clear to us. What is meant by "including a change of pack size"? If we sell a package consisting of 6 pieces, can we change the pack size to maybe 2 x 3 pieces? Or even sell single pieces (e.g. for demo purposes)? What about the DoC? As far as I know, it only refers to the package of 6 pieces. Doesn't it become invalid as soon as I split the content? What about labelling requirements if I was allowed to split (apart from requirements in Art. 16 (3))? So to sum up, what would be a real use case for Art. 16 (2b)? Does it rather mean that if the manufacturer sends us 10 x sets of 6 pieces, we are allowed to separate the sets but without splitting each set. So we can sell the single sets instead of 10 at the same time...

2) Regarding Art. 16 (4): How often do we have to inform/provide samples to the manufacturer and CA? Assumed "making available" means any supply of a device for consumption, doesn't that imply that it means every selling activity? So do we have to inform them once and can have repeated selling of the same "modification" of the pack size or do we have to inform them of every sale?

3) Regarding Art. 16 (4): What certificate is required ("[...] certificate issued by a notified body designated for the type of devices that are subject to activities [...]")? Is an ISO 13485 certificate sufficient? Is any additional specific wording on existing certificate required? Is any separate (MDR?) certificate required? So which type of notified body is required and what notification should it have?

Hope you can help us...all guidance we found so far does not go down to that detail.

Thanks in advance.

Asuka

 

[Ronen E]

What is your rationale supporting that the repackaging is necessary in order to market the device in the relevant Member State?

 

[Asuka23741082402]

Our customers do not want to buy 6 at a time but only 3 or sometimes only even 1.

 

[Ronen E]

Our customers do not want to buy 6 at a time but only 3 or sometimes only even 1.

In my opinion this is a weak argument in the current context. It is a sales argument that (apparently) has nothing to do with any specific Member State. I'm not sure that you can utilise Article 16 2b.

 

[Asuka23741082402]

What would be a good argument instead? Which use case is Art. 16 supposed to address?

 

[Ronen E]

Are you asking about Article 16 in general or about Article 16 2b?

 

[Asuka23741082402]

Sorry...16 (2a and b) and especially what's meant by the limitation "necessary in order to market the device in the relevant Member State"

 

[Ronen E]

First of all, s. 2 of Article 16 is (in its entirety) an exception to s. 1c, that covers a situation where an entity other than the Manufacturer modifies the device; i.e. s. 2 - where it applies - exempts from full assumption of Manufacturers' obligations in some circumstances where the device is modified (in general, and unless otherwise specified, the packaging is considered part of the device).

S. 2a relates to provision of information, including translation and Member State-specific additional information. It seems less relevant to your situation.

My take on s. 2b is that a change in packaging is exempt in situations where labelling on the outer packaging is necessary in the local language - either due to explicit Member State legislation or due to practical considerations. More generally, there might be other (non-labelling) local legal requirements that might necessitate outer packaging changes, and these might include limitations regarding pack size. This is only my private interpretation - I wasn't involved in the development of the MDR, I don't know what the authors motives actually were and I'm reading the MDR just like you. One thing I'm quite certain about - the justification has to somehow relate to specific Member states. It can't be generic.

Maybe s. 37 of the MDR's preamble can shed some light on this (if one has the legal background or the diligence to fully study the context ):

Parallel trade in products already placed on the market is a lawful form of trade within the internal market on the basis of Article 34 TFEU subject to the limitations arising from the need for protection of health and safety and from the need for protection of intellectual property rights provided for under Article 36 TFEU. Application of the principle of parallel trade is, however, subject to different interpretations in the Member States. The conditions, in particular the requirements for relabelling and repackaging, should therefore be specified in this Regulation, taking into account the case-law of the Court of Justice (1) in other relevant sectors and existing good practice in the field of medical devices.

Footnote (1):

Judgment of 28 July 2011 in Orifarm and Paranova, joined cases C‑400/09 and C‑207/10, ECLI:EU:C:2011:519.

 

[Asuka23741082402]

Thank you very much. This seems logical to me as well. So, for my first question maybe this is already the answer. We are just not allowed to change the pack size only because we (or our customers) want it. Just in case of a regulatory need by the relevant Member State we might do that.

But what about my other 2 questions. Does anyone have more detailed information on that topic?

 

[Ronen E]

S. 4 is relevant only if you make the changes, assuming the Manufacturer's obligations.