EU Legislation for drug-device combination products

Article 117 of the MDR stipulates that, point 12 of Section 3.2. of Annex I to Directive 2001/83/EC is replaced by the following:

‘(12) Where, in accordance with the second subparagraph of Article 1(8) or the second subparagraph of Article 1(9) of Regulation (EU) 2017/745 of the European Parliament and of the Council (*), a product is governed by this Directive, the marketing authorization dossier shall include, where available, the results of the assessment of the conformity of the device part with the relevant general safety and performance requirements set out in Annex I to that Regulation contained in the manufacturer’s EU declaration of conformity or the relevant certificate issued by a notified body allowing the manufacturer to affix a CE marking to the medical device.

If the dossier does not include the results of the conformity assessment referred to in the first subparagraph and where for the conformity assessment of the device, if used separately, the involvement of a notified body is required in accordance with Regulation (EU) 2017/745, the authority shall require the applicant to provide an opinion on the conformity of the device part with the relevant general safety and performance requirements set out in Annex I to that Regulation issued by a notified body designated in accordance with that Regulation for the type of device in question.

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(*) Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC (OJ L 117, 5.5.2017, p. 1).’

From a conformity assessment point of view of the device part of the drug-device combination product, the manufacturer has two options to include in the Market Authorisation Application (MAA) that is submitted by the manufacturer to the European Medicines Agency (EMA):

1. to include a CE-Certificate submitted by a notified body as proof that the device part complies with the relevant General Safety and Performance Requirements (GSPRs) or
2. to lodge an application with a notified body in order to obtain a Notified Body Opinion (NBOp) that the device part complies with the relevant GSPRs

Dossier for EU Submission

Article 117 of the MDR requires manufacturers placing drug-device combination products onto the EU market as an integral device and marketing them as a medicinal product to seek a NBO.
Note: For Non-Integral drug-device combination products: the Device must bear the CE marking of conformity in accordance with the Annex V of the MDR.

If the device is not CE marked, a Notified Body that is designated in accordance with that Regulation for the type of device in question, then confirms whether the device part is compliant with the relevant GSPR and provides in an NBOp Report to the manufacturer a recommendation on conformity of the drug-device combination product to Article 117 to be included in the MAA that is submitted to the EMA.

The submission dossier consists of three things:

1. Context (a letter explaining of what is being requested and why). Following selection of the notified body, this letter will result in a assessment contract
2. Authorization for the notified body to carry out the NBOp by returning the signed assessment contract.
3. The Technical Documentation (TD) itself (i.e., objective evidence to demonstrate compliance). The TD must be written in a language agreed with the notified body.

The TD to be submitted to the notified body consists of the following parts: