Most Drug Manufacturers may not feel the need to monitor the Medical Device Regulations. However, for those that develop and distribute combination products, there are some recent regulatory changes of which you should be aware. One of the first European Union Medical Device Regulation (EU MDR) guidance documents was just published under the European Medicines Agency (EMA):

“Article 117 of the EU MDR introduces a new requirement for medicines with an integral device (e.g. the medicinal product and device form a single integrated product such as pre-filled syringes and pens, patches for transdermal drug delivery and pre-filled inhalers, etc.). The marketing authorization application should include a CE certificate or declaration of conformity for the device or, if it is not CE marked …, the applicant must include an opinion from a notified body on the conformity of the device.”

Because the device portion of a combo product will be required to meet EU MDR Annex I:

  • a risk management system,
  • chemical, physical and biological properties of the product,
  • labeling and instructions for use,
  • conformity assessment,
  • as well as other requirements, will need to be in place for a combo product released in the EU, or if there is a substantial change to an already marketed product, after May 2020.

In addition, requirements under 21 CFR Part 4, Subpart B take effect for combination products on the market in the United States on 31-July-2019. This regulation states that post-market reporting requirements are to be implemented for the product as a whole; meaning that medical device reporting will need to be in place in the event the device portion of a combo product fails, and vice versa for devices that contain a drug.

For drug manufacturers who may not have integrated all medical device requirements into their combination product quality systems, this may represent a significant change. Validant has been assisting multiple clients in assessing the impact of the changing regulations and helping them to implement compliant solutions. If you’d like more information or need assistance in meeting these requirements for your combination products, please contact us.