Examples of Combination Products - MDR Article 1 (8) and MDR Article 1(9)

[marie luis murray]

Dear readers,

combination products are defined in MDR Article 1 (8) and MDR Article 1(9).

products within the second sub-paragraph of Article 1(8) are combination prodcuts that will be regulated as medicines. See article below

Article 8:

"Any device which, when placed on the market or put into service, incorporates, as an integral part, a substance which, if used separately, would be considered to be a medicinal product as defined in point 2 of Article 1 of Directive 2001/83/EC, including a medicinal product derived from human blood or human plasma as defined in point 10 of Article 1 of that Directive, and that has an action ancillary to that of the device, shall be assessed and authorised in accordance with this Regulation.

2n paragraph -->"However, if the action of that substance is principal and not ancillary to that of the device, the integral product shall be governed by Directive 2001/83/EC or Regulation (EC) No 726/2004 of the European Parliament and of the Council ( 1 ), as applicable. In that case, the relevant general safety and performance requirements set out in Annex I to this Regulation shall apply as far as the safety and performance of the device part are concerned "

Can someone provide me an example of these types of combination products? I haven't been able to find any example!!!

Thanks in advance!

 

[TorstenKn]

Dear Marie,

That is an excellent question, because if you see the Article 1(8) and (9) in context than there is some overlap:

In Article 1 (8):
Part A: single-integral product: Device with "ancillary" substance --> combination regulated as device
Part B: single-integral product: Substance with "ancillary" device --> combination regulated as a drug

In Article 1 (9):
Part A: Drug Delivery/Administration device (non-integral) --> regulated as device
Part B: Drug Delivery/Administration device (integral) with substance --> regulated as a drug

Now, if we see both parts, there is an overlap between both Parts "B". A pre-filled syringe, an intra-uterine delivery system (IUS), a drug-releasing patch and similar products are falling under the definition of the second part of Article 1(9) and somehow also under the second part of Article 1(8). Those products were already described in the MEDDEV 2.1/3 rev.3 under the MDD.

However, if you want to see an example for a product that only falls under Article 1 (8) part B, this isn't easy. All examples I have, are at least to some extend, aimed to support drug delivery/administration, even if not exclusively. Therefore I am not sure if this product type exists.

Best regards,
Torsten

 

[marie luis murray]

Dear TorstenKn,

thanks a lot! really helpful!!

Exactly, I understood the same --> there is some overlap between these two clauses.

However, after reading EMA quality draft guideline for comb.products. where it seems that they differentiate between the two types of products, I was wondering which Comb.products could fall under the second sub-paragraph of Article 1(8) .

Once I attended a webinar where they put as an example of the second sub-paragraph of Article 1(8) an "intelligent pill" but I did not understand why.

Thanks again and let's see if someone comes up with an example!

ML

 

[TorstenKn]

Dear Marie,

Actually the intelligent pill would be an example. Let's assume you have a normal capsule which in addition to the drug includes a sensor. While the capsule itself would be part of the drug product and not considered a device part, the sensor would be considered device part. In such case the device part would not support in any way the drug delivery, but would measure something, e.g. the temperature of the body, pH-Value or whatever. That combination would fall under Article 1(8) only.

However, I would have my doubts that the EC had such an example (which is hypotethical) in their mind, when setting up the MDR. Especially as there is basically not difference between handling of the two second paragraphs of Article 1(8) and (9). Therefore I think it was just a mistake.

Best regards,
Torsten