A Notified Body for medical devices with ancillary medicinal substances

BSI recognises that regulatory requirements for manufacturers of medical devices incorporating medicinal substances can be challenging. BSI understands that the addition of an ancillary medicinal substance to your device will bring added benefits but that the regulatory process will be more demanding.

BSI is proud to offer a full Notified Body service in this area. Our dedicated in-house team of experts are here to guide you efficiently through this intricate regulatory process. With a long history in this field and a vast range of certified devices, BSI has the expertise and knowledge to guide you through this specialized process.

Medicinal dossier guidance

Medicinal dossier guidance

Download our guidance for devices which incorporate an ancillary medicinal substance and fall under Rule 14 of EU 2017/745 (MDR).

Download the guidance >

Classification of medical devices with ancillary medicinal substances

Early classification of medical products containing or delivering drug substances is essential in order that the appropriate regulatory path is determined:

  • Medical products designed to deliver drugs, supplied without the drug itself are regulated as medical devices, e.g. infusion pump.
  • Medical products designed to deliver drugs, supplied with the drug combined, are regulated as medicinal products, e.g. sub-dermal contraceptive implants and insulin-filled syringes.
  • Medical products which incorporate as an integral part a substance which, if used separately, can be considered to be a medicinal product and which is liable to act on the human body are regulated as Medical Devices, e.g. catheters coated with heparin.

To ensure an accurate classification you must consider the following questions:

  • Whether any constituents, if used separately, may be considered to be a medicinal product, for example silver, some herbal ingredients, analgesics, etc.
  • What claims are made for the product – what is the intended purpose?
  • The method by which the principal intended action is achieved – mode of action?
  • Liability of the medicinal substance to act on the human body.

Examples of Ancillary Medicinal Substances include:

  • Gentamycin,
  • Human Serum Albumin
  • Chlorhexidine
  • Fluoride
  • Lidocaine
  • Thrombin, Growth Factors, recombinant peptides
  • Heparin
  • Silver, Triclosan, Polyhexanide, Idoine

  • Nicotinamide, Hydrogen peroxide
  • Paclitaxel, Sirolimus, Novolimus
  • Benzocaine
  • Erythromycin, Vancomycin, Doxycycline
  • Rapamycin
  • Allopurinol, Mannitol, Adenosine
  • Herbal medicines
  • Dexamethasone

Medicinal consultations

During the certification process for devices with an ancillary medicinal substance, the Notified Body must review device aspects and seek the opinion of a European Competent Authority in relation to the ancillary medicinal substance incorporated in the device.

Prior to seeking the opinion of the Competent Authority, BSI must verify the usefulness of the medicinal substance incorporated in the device.

The Competent Authority will provide the Notified Body with a scientific opinion on the quality and safety of the substance taking in to account the clinical benefit/risk profile of the incorporation of the medicinal substance into the device.

The review of the medicinal substance by the Competent Authority may take up to 210 days and usually runs in parallel with the review of the device by the Notified Body.

Why choose BSI for certifying your devices with ancillary medicinal substances?

BSI is very proud of our unrivalled history in certifying medical devices incorporating medicinal substances. With our extensive knowledge and experience in this area, BSI will provide you with timely, responsive and informed support at every stage of the certification process. Every case is different so feel free to contact us and we will be happy to discuss your individual circumstances.

A notified body’s perspective on the clinical evaluation requirements under the Medical Device Regulation

jmdr articleUnderstanding of the clinical evaluation process for medical devices against the requirements of the MDR, relevant Medical Device Coordination Group guidance documents is critical for all manufacturers.

Hear from BSI’s Richard Holborow, Head of Clinical Compliance in his recent article in the Journal of Medical Device Regulation on the requirements for clinical evaluation under the MDR from a Notified Body’s perspective and how to meet those requirements.

Download the article >

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