Combination products, medicinal products with an integral Medical Device (integral DDC), and medicinal products with co-packaging device

Various products ‘combine’ Medical Devices with medicinal products. Such combination products can either be regulated as:

- Medicinal products, e.g., pre-filled syringes, or as,

- Medical devices, e.g., drug-eluting stents.

For medicinal products the requirements of Directive 2001/83/EC apply [1].

For combination products, before a Notified Body can issue a CE certificate, it must seek a scientific opinion from EMA on the quality and safety of the ancillary substance if it is derived from human blood or human plasma, or if it is within the scope of the centralised procedure for the authorisation of medicines. For other substances, the Notified Body can seek the opinion from a national competent authority or EMA, e.g. in cases where EMA has already evaluated a medicine containing the same medicinal substance.

There are also some configurations referred to as ‘co-packaged’ combinations of a medicinal product and Medical Device, e.g., a package containing a vial of a medicine, a syringe, a needle and a swab. Medical Devices that are co-packaged or obtained separately must be CE marked in accordance with the Medical Device legislation [2].

For information about this and the above-mentioned combinations, please refer to the recent Q&A document published by the EMA [3].


[1] DIRECTIVE 2001/83/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 6 November 2001 on the Community code relating to medicinal products for human use Source:

[2] Europe: Medical Device Market Approval | Credevo Articles Source:

[3] Questions & Answers for applicants, marketing authorisation holders of medicinal products and notified bodies with respect to the implementation of the Medical Devices and In Vitro Diagnostic Medical Devices Regulations ((EU) 2017/745 and (EU) 2017/746) ( Source: