Drug Device Combinations - Documentation Requirements for Notified Body Opinion Submission File

On 2020, April 1st , TEAM-NB, the European Association for Medical Devices of Notified Bodies, has released a new position paper covering “Documentation Requirements for Drug Device Combination Products Falling in the Scope of Article 117 of MDR 2017/745”.

According to MDR's article 117, for drug device combination products falling under the definition of Art 1(8) and/or Art 1(9) of MDR, a Notified Body must be involved to give an opinion on the conformity of the device constituent part of the product with the relevant requirements of Annex I of the Medical Device Regulation (MDR 2017/745). This opinion is then expected by the competent medicinal authority (e.g. EMA) which has jurisdiction over the product concerned as part of the Marketing Authorization Applications (MAA) of the final medicinal product.

WHAT’S NEW? WHAT HAS BEEN CLARIFIED WITH THE DOCUMENT? A detailed analysis of the text of the position paper is available in our article here.