Impact of the Art. 117 of EU MDR 20/17/745 on the Drug Device Combination Products

Drug device combinations (DDC) where the medicinal product incorporates a medical device in an integral manner will be subject to Art. 117 of the MDR which stipulates that a MAA for an integral DDC shall include evidence of the conformity of the device part with the relevant General Safety and Performance Requirements (GSPR). If the device component is not CE marked, and a Declaration of Conformity is not available, a Notified Body (NB) opinion on the conformity of the device with the relevant GSPRs is required to be submitted with the MAA.

Obtaining a NB opinion prior to submission of the MAA requires a sea-change in the way of preparing MAA dossiers for DDC products. For pharma companies that to-date had no interaction with a NB, the implementation of MDR requires the selection and relationship-building with a NB and a determination of the outline, scope, and level of detail necessary for the device technical documentation in support of the opinion request to ensure a rapid and efficient review by the NB in order not to delay the MAA timeline.

The CMC SPIN would like to know if there is interest from the CMC community for a webinar to review the NBs expectations and the process to timely obtain a NB Opinion. The webinar will focus on Timeline, Requirements and Impact on the MAA Process, industry experience so far, and EMA key messages.

Please share your questions below so that we can provide answers at the webinar.

Timing of the webinar, in case of sufficient interest, will be communicated soon.

We appreciate your feedback.

CMC SPIN Steering Group.

1 Like

At the moment there seems to be considerable variation in expectation/requirements between NBs and the Team-NB guidance has only addressed this to a limited extent. At present the issue is finding a NB to accept a request for A117 Opinion within a reasonable timescale is probably the deciding factor. I fear there is not yet sufficient consistency in the process/requirements to make a webinar valuable.
Neil

Whilst not directly related to the MDR, do we understand yet how the MHRA will deal with this question for UK(GB) registrations?

I could be interested even if I have already experienced the process with one of my client. My interest is to get the NB common template.

Thanks for your feedback so far.
in reply to the question on GB requirements, on the MHRA website, there are useful information on How to register Devices in GB after Brexit: Regulating medical devices in the UK - GOV.UK. There is no yet information on the integral combination products. However, since GB will follow MDD and not implement MDR, the understanding is that the NB opinion is not required. My understanding is that MHRA will publish a guidance on integral combination products. We’ll keep monitoring this space for additional CMC guidance from MHRA.

As for the requirements and process of the NBOp request, there was an informative EMA webinar last November 2020 where NB and EFPIA brought early experiences with NB opinions and EMA provided some clarifications on expectations.

I hope this helps
Federica

Note that BSI has issued the first NBOp with regard to Article 117

according to our discussion with MHRA is no change, just as before: MDD ER in the region annex of the meds. authorization/variation submittal and no specific NB opinion. My fear is that this may change quickly before we can get a submission in! fingers crossed
neil

Hi there,

It will be useful to get an insight from the NB’s who have successfully issued an opinion based on Article 117.
With regards to UK I would like to ask what MHRA will want to see from the NB at time of maa submission of a drug device combination product.

Thanks!

I can recommend the two BSI webinars on Post-brexit Legislation for Medical Devices if you want to know more about UK/GB registrations. The first webinar was in September 2020 and the second in January 2021. Excellently explained by Dr. Jaynath Katta.
I’m pretty sure that you can ‘attend’ them as on-demand webinars via the BSI website:
Medical Devices Webinars | BSI (bsigroup.com)

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