A Notified Body for
devices utilizing materialsof animal origin
Updated May 2017

Unrivalled expertise from the premier Notified
Body for devices utilizing materials of animal origin
Experience and expertise
BSI recognizes that the requirements for medical device
manufacturers who utilize materials of animal origin can beburdensome. We have the expertise, knowledge and provencapability to provide you with the excellence you need through thisdifficult process.

Our full scope covers the entire spectrum of devices in combination
with:• EU Regulation 722/2012• EN ISO 22442 and all other aspects related to your certificationneeds across a wide range of device technologies

BSI is one of a few Notified Bodies designated to certify devices
manufactured utilizing materials of animal origin including thosederived from Transmissible Spongiform Encephalopathy (TSE)susceptible species*. Our large in-house team of experts understandthe challenges in gaining successful certification for your products.

• sourcing and processing controls• inactivation and elimination of viruses and TSE agents• Quality System assessments

Our auditors are qualified to conduct assessments at slaughterhousefacilities, tissue processors and all the way through themanufacturing chain to the finished product.

Market access* TSE Susceptible Species are: bovine, caprine, deer, elk, feline, mink, ovine.

Experience of starting materials and derivatives
Forestomach

Gelatin
Collagen(hide, bone, tendon)

Subintestinal
mucosaTallow andtallow
derivatives

BoneHeartvalvesAnimal origin
technologies

Wool fat andrelated
derivatives
Chondroitin sulphate

Pericardium
ChitosanHyaluronic acid

Our in-house expertise and efficient review services means yourproduct reviews won't slow down your launch plans, helping you stayahead of the competition.

Bespoke service
Suppliers of materials of animal origin can also apply to BSI for
EN ISO 13485 certification which may provide a competitive
advantage when seeking to do business with device manufacturers.
Certification will include a review against relevant requirements ofEN ISO 22442 and may be taken in to consideration by NotifiedBodies during conformity assessments.

Device technologies• Pericardial patch for reinforcement ofstaple lines• Absorbable / non-absorbable meshes(bovine, porcine, fish oil-coated)•Soft tissue• Gelatin sealed cannulae• Gelatin sealed grafts• Pericardial patch for use in peripheral
vascular reconstruction• Transcatheter heart valve implant device

VascularWoundcare

Clinicalareas

Neurosurgery• Dural graft• Resorbable nerve products

Wound dressings, powders, matrices• Collagen dermal template• Haemostats (chitosan, bovine, porcine)• Dental wound dressings

AIMD• Ventricular assist devices

Orthopedic
and dental• Cartilage repair device• Bone substitutes• Bone void fillers• Ceramic matrix putty / strips• Resorbable dental membranes

Specialized training
BSI offers a specialized one-day course covering the use of animal
tissue in medical devices: Utilizing Tissue of Animal Origin. The
course provides expertise from our product specialists to allow you
to better understand the requirements for these products.

For more information, or to book a course with us, visit our website:bsigroup.com/medical-training or call +44 345 086 9000

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

BSI Group - EMEA
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Davy Avenue,
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United Kingdom

BSI Group Asia Pac
BSI Group - Hong Kong
23rd Floor, Cambridge House
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© BSI Group

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