You are here: / / EU MDR 2017/745 Compliance for DDC

Compliance for DDC

According to Article 117 of Regulation (EU) 2017/745 (amending Annex I to Directive 2001/83/EC, point 12 of section 3.2) requires that marketing authorisation applicant for an integral DDC should include, where available, the results of the assessment of conformity for the device (i.e. the declaration of conformity or the relevant CE certificate issued by a notified body).

If the dossier does not include the results of the assessment of conformity, and an EU certificate from a notified body would be required if the device was used separately, then the applicant will be required to provide an opinion from a notified body on the conformity of the device part with relevant requirements of Annex I to Regulation (EU) 2017/745 as part of the marketing authorisation application.

Integral DDCs are products which include:

  1. devices that when placed on the market or put into service incorporate, as an integral part, a substance that, if used separately, would be considered as a medicinal product, provided that the action of the substance is principal (based on Article 1(8) MDR). 
  2. devices intended to administer a medicinal product, where they form a single integral product intended exclusively for use in the given combination and which is not reusable (based on Article 1(9) MDR). Typically, these devices have measuring, metering or delivery functions.

Non-integral DDCs are those DDCs for which the two or more separate components (i.e. medicinal product(s) and device(s)) are not physically integrated during manufacturing, but where the medicinal product and the specific device(s) are combined for administration. 

Devices in non-integral DDCs are co-packaged and supplied along with the medicinal product, or where the product information of the medicinal product refers to a specific device to be used with the medicinal product, but the device is obtained separately.

The content of the underlying definitions and regulatory concept (e.g. which devices must be CE marked and which not) remains the same, but article 117 (2nd paragraph) defines a major hick-up and possible time-consuming addition compared to Council Directive 93/42/EEC (#MDD):

“Where, 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 (GSPR) set out in Annex I to that Regulation issued by a notified body designated in accordance with that Regulation [MDR] for the type of device in question.”

What does that mean?

Article 117 basically says that, although the device itself is regulated as a medicinal product and therefore not to be CE marked, a notified body needs to be involved to provide evidence (“opinion”) about compliance with the #GSPR.

Which products are affected?

In order to consider a product an integral “drug-device combination”, all the following questions should be considered:

  1. Does the delivery device and the medicinal product form a single integral product or the delivery devices is non-integral product, but is co-packaged and supplied along with the medicinal product, or the Product Information of the medicinal product refers to the specific device to be used with the medicinal product, but the device is obtained separately?
  2. Is the integral product intended exclusively for use in the given combination (Article 1(9) MDR)?
  1. Is the integral product single use only (Article 1(9) MDR)?
  2. Is the primary mode of action of the final combination a pharmaceutical action?

If the answer to all the above 4 questions is yes, the final combination product fulfils the definition of an “integral drug-device combination” and the medicinal product shall be governed by Directive 2001/83/EC or Regulation (EC) No 726/2004.

However, for the device part, the compliance with the relevant general safety and performance requirements, set out in Annex I to MDR, shall be demonstrated for stand-alone medical devices and drug-device combinations, as far as the safety and performance of the device part of the single integral product are concerned.

What are the take-away’s?

  • Ensure GSPR (General Safety and Performance Requirements) are met, regardless of the regulatory pathway
  • For products to be CE marked, address relevant topics of the MDR (i.e. Annex II and III) and get the products CE marked
  • For products regulated as medicinal products, evaluate classification of the device constituent part; if not class I, approach a Notified Body (sooner rather than later) to plan on obtaining an opinion regarding compliance with the GSPR.

How can we help?

GemarMed’s consultants have specific expertise to define the device Technical Documentation for MDR CE conformity assessment, according to MDR, Annex II and Annex III, to provide evidence of compliance with the relevant general safety and performance requirements (GSPR), set out in Annex I to MDR, for stand-alone medical devices and drug-device combinations.

Let’s keep in Touch

I accept terms and privacy conditions.

This contact form is deactivated because you refused to accept Google reCaptcha service which is necessary to validate any messages sent by the form.