CE Marking a Medical Device That Incorporates a Medicine
We are consistently asked about CE marking a medical device. Our team of medical device experts has written a brief overview for how a company can secure CE marking for a medical device that incorporates a medicine.
Medical devices come in all shapes and sizes, ranging from wheelchairs to drug-eluting stents and everything in between. All medical devices must meet the requirements of the EU Medical Device Directive 93/42/EEC in order to be CE marked and placed on the European market. However, when a medical device incorporates a medicine there are some specific requirements which must be met.
There are two types of products which incorporate a medicine:
- Products which are designed to deliver medicines which are supplied combined with the medicine e.g. pre-filled insulin syringe – these are regulated as medicinal products
- Medical devices which incorporate a substance which if used separately is classified as a medicine, and the action of the medicine is ancillary to that of the device e.g. drug-eluting stent, bone cement containing antibiotic
The first category of product is covered by pharmaceutical legislation and is not subject to CE mark. Products in the latter category are classified as medical devices – here are a few examples of medical devices which contain an ancillary medicine:
Drug-eluting stents are placed in diseased peripheral or coronary arteries. The stent achieves its intended medical purpose through physical means, acting as a scaffold to keep the artery open, whilst a drug coating prevents cell proliferation that could otherwise block the stented artery. As the primary mode of action is through physical means rather than through the action of the drug, the product is regulated as a medical device.
Another typical example is wound dressings which incorporate silver. Silver sulfadiazine is classified as a medicine and may be incorporated in to wound dressings for its antibacterial properties. However, the primary mode of action of a wound dressing is physical i.e. the absorption of exudate from the wound and protection of the wound is achieved through use of the dressing. The action of silver is considered to be ancillary to that of the wound dressing.
The main considerations for determining if the action of the medicine is ‘ancillary’ are as follows:
- How does the product achieve its intended purpose?
- What is the primary mode of action?
- Liability of the medicine to act on the human body
Medical devices which incorporate an ancillary medicinal substance are classified in the highest risk category, Class III. The presence of a medicinal component adds a greater amount of complexity to the CE marking approval process. Section 4.3 of Annex II and section 5 of Annex III of the Medical Device Directive 93/42/EEC requires that a Notified Body consult a Competent Authority where medicinal components are used in medical devices, before taking a decision on providing CE Mark certification. The safety and quality of the medicinal component must be verified, taking account of the intended purpose of the device.
The Notified Body must consult the Competent Authority in writing, ideally 6 months before the intended submission to the Competent Authority. A pre-submission meeting is normally held approximately 2 months before the anticipated submission date between the Manufacturer, Notified Body and Competent Authority. The Competent Authority makes its decision within 6 months.
This additional procedure significantly increases the time, cost and complexity involved in the product approval process of the medical device. However, medicinal components come with their own risks. Assurance that medical devices which are used by patients and the general public are safe and effective is everybody’s goal.
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