Europe GMP medical devices - Combination products - Ancillary medicinal substance

[marie luis murray]

Dear readers,

we are willing to certify a medical device (MD) composed of substances as a Class III ,since one of the substances will be considered ancillary. The other ones, are part of the MD (have a physical MoA)

Our questions are:
- we think that the ancillary substance should be produced and controlled under GMP conditions. Thus, we should be certified as "gmp-compliant or another gmp-compliant company should produce the medicinal susbtance. Is this right?

-But, Is the fact that this GMP-substance is present means that the whole product (the non-pharmacological substances) should also be analysed under GMP?

we have read that the FDA allows you to show compliance with a QS system (CFR 820) and then apply some specifics requirements related with the drug gmp (CFR 211). However, we do not know which requirements apply to the EU...


many thanks in advance!

MLM

 

[yodon]

I don't know if this will help but the EMA put out a draft guidance back in 2019.

 

[marie luis murray]

hi yodon,
I'm afraid it does not apply since is for Combination products but regulated as drugs and not devices. Our product will be regulated as a MD.

thanks anyway!

 

[planB]

marie luis murray,

in case your product is regulated as MD with the active pharmaceutical ingredient being only ancillary, it is still adequate to be certified to ISO 13485 only. You (or the contractor) should have provisions in your QMS, accounting for the drug-specific GMP requirements, though, which are, but not limited to
- drug-related incoming inspection including identification activities
- drug-related design, verification, validation and manufacturing steps
- batch-wise final release of your product including drug-related verification activities

Yodon's link is indeed helpful, as many concepts laid out there are applicable to any combination product irrespective whether the primary mode is a medical device or a medicinal substance.

In terms of regulations, the MDR applies - quote from Chapter I, § 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.

and also have a look into Annex IX, Chapter 2, § 5.2. Procedure in the case of devices incorporating a medicinal substance .

Hope this helps,

 

[marie luis murray]

hi planB, thanks a lot! this really helps.

However, I'm not sure if I have understood it well. Sorry because I'm not really familiar with gmp requirements for MD...

Since we are going to "produce" the product with the ancillary substance, does this mean that we should be certified under GMP for being able to comply with the drug-related and batch-wise activities?

Or, just being iso 13485 certified is enough as long as 1) the supplier of the ancillary substance is GMP certified and 2) we conduct the rest of the analysis of the product using validated methods under our 13485 system?

thanks again
MLM