A Notified Body for medical
devices with ancillary
medicinal substances

Updated February 2016

BSI specializes in medical devices with ancillary
medicinal substances
Experience and expertise
BSI recognises that regulatory requirements for manufacturersof medical devices incorporating medicinal substances can bechallenging. With a long history in this field and a vast range ofcertified devices, BSI has the expertise and knowledge to guide you
through this specialized process.

BSI understands that the addition of an ancillary medicinal substanceto 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.

Experience in Device Drug Consultations• Medicated condoms
Intraocular irrigation• Contact lens
• Treated examination gloves• Media for assisted reproduction
Otherstechnology• Organ preservation solutions•• Drug eluting stents• Coated vascular prosthesis• Antimicrobial catheter

VascularHaemostats• Wound powders, dressings barriers
and films• Skin preparations• Sutures
Woundcare• Wound debridement andirrigation solution• Creams•

Drug Device
Technologies

ActiveMedicalDevices•••

ActiveImplantable• Antibacterial envelope in amesh pouch for ICD

Blood parameter monitoring
SystemSystems to preserve and treat
the blood
Haemodialysis equipment

Orthopaedicand Dental• Bone cement / graft• Injectable spine cement• Dental varnishes

Examples of Ancillary Medicinal Substances
Gentamycin
Human Serum Albumin
Chlorhexidine
Fluoride
Lidocaine
Thrombin, Growth Factors, recombinant
peptidesHeparinSilver, Triclosan, Polyhexanide, IdoineNicotinamide, Hydrogen peroxide
Paclitaxel, Sirolimus, Novolimus
Benzocaine,
Erythromycin, Vancomycin, Doxycycline
Rapamycin

Allopurinol, Mannitol, Adenosine
Herbal medicines
Dexamethasone

Classification

Medicinal Consultations

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

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.

• Medical products designed to deliver drugs, supplied without thedrug 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 bodyare regulated as Medical Devices, e.g. catheters coated withheparin.
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.

Prior to seeking the opinion of the Competent Authority, BSI mustverify the usefulness of the medicinal substance incorporated in thedevice.
The Competent Authority will provide the Notified Body with ascientific opinion on the quality and safety of the substance taking into 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 ofthe device by the Notified Body.

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

Your partner in worldwide compliance: Call BSI today on +44 345 080 9000
or visit bsigroup.com/medical-devices – to start your partnership

BSI Group - EMEA
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Davy Avenue,
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United Kingdom

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BSI Group - Hong Kong
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TaiKoo Place,979 King’s Road,
Island East, Hong Kong

T: +1 800 862 4977/703 437 9000
F: +1 703 437 9001
E: us.medicaldevices@bsigroup.com

T:7 +44 345 080 9000
F:7 +44 1908 814920
E:7 eu.medicaldevices@bsigroup.com

T: +852 3149 3320
F: +852 2743 8727
E: hk@bsigroup.com

Visit us online at: bsigroup.com/medical-devices© BSI Group

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