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(1)

Animal Tissues

– Update on Requirements

September 2013

(2)

93/42/EEC - Animal Tissue - Conformity Assessment

1.

• 93/42/EEC ER#8.2 and EN ISO 22442 applicable • 93/42/EEC Rule 17 not applicable

2.

• 93/42/EEC ER#8.2 and EN ISO 22442 applicable • 93/42/EEC Rule 17 applicable

• EU Regulation 722/2012 not applicable

3.

• 93/42/EEC ER#8.2 and EN ISO 22442 applicable • 93/42/EEC Rule 17 applicable

(3)

90/385/EEC, 93/42/EEC & 98/79/EC

90/385/EEC

There are no Essential Requirements that mention animal tissues.

EN ISO 22442 – This European Standard has been developed for

medical devices regulated by the Medical Device Directive

93/42/EC as amended by 2003/32/EC (see Annex ZA). By analogy, it could be applied for active implantable medical devices

regulated by the Active Implantable Medical Device Directive 90/385/EC.

98/79/EEC

There are no Essential Requirements that mention animal tissues.

EN ISO 22442 does not apply to in vitro diagnostic devices.

(4)

93/42/EEC - Animal Tissue - Conformity Assessment

1.

• 93/42/EEC ER#8.2 and EN ISO 22442 applicable

• 93/42/EEC Rule 17 not applicable

(5)

93.42.EEC Annex I

Essential Requirement #8.2

Tissues of animal origin must originate from animals that have been subjected to veterinary controls and surveillance adapted to the

intended use of the tissues.

Notified bodies shall retain information on the geographical origin of the animals.

Processing, preservation, testing and handling of tissues, cells and substances of animal origin must be carried out so as to provide

optimal security. In particular safety with regard to viruses and other transmissible agents must be addressed by implementation of

validated methods of elimination or viral inactivation in the course of the manufacturing process.

(6)

EN ISO 22442 – 1, 2 & 3 … + 4

Medical devices utilizing animal tissues and their

derivatives —

Part 1: Application of risk management

Part 2: Controls on sourcing, collection and handling

Part 3: Validation of the elimination and/or inactivation of viruses and transmissible spongiform encephalopathy (TSE) agents

Part 4 (PD/ISO TR): Principles for elimination and/or inactivation of transmissible spongiform encephalopathy (TSE) agents and

(7)

EN ISO 22442 – 1

Clause 3.1 animal

any vertebrate or invertebrate [including amphibian, arthropod (e.g. crustacean), bird, coral, fish, reptile, mollusc and mammal]

(8)

93.42.EEC Annex IX

Rule 17

All devices manufactured utilizing animal tissues or

derivatives rendered non-viable are Class III except

where such devices are intended to come into contact

with intact skin only.

Devices that contact intact skin only

Tallow or tallow derivatives i.e. stearates

Milk

Silk

Beeswax

Hair

(9)

93/42/EEC - Animal Tissue - Conformity Assessment

2.

• 93/42/EEC ER#8.2 and EN ISO 22442 applicable • 93/42/EEC Rule 17 applicable

(10)

3.

• 93/42/EEC ER#8.2 and EN ISO 22442 applicable • 93/42/EEC Rule 17 applicable

• EU Regulation 722/2012 applicable

(11)

2003/32/EC  EU Regulation 722/2012

2003.32.EC:

COMMISSION DIRECTIVE 2003/32/EC – introducing detailed

specifications as regards the requirements laid down in 93/42/EEC with respect to MD manufactured utilising tissues of animal origin

EU Regulation 722.2012:

COMMISSION REGULATION (EU) No 722/2012 – concerning

particular requirements as regards the requirements laid down in 90/385/EEC and 93/42/EEC with respect to AIMD and MD

(12)

EU Regulation 722/2012

Notified Body application for designation – 30 November 2012

Competent Authority to notify other Competent Authorities and EU Commission of Notified Body designation – 28 February 2013

The regulation will apply from – 29 August 2013

Holders of existing MDD Design Examination / Type Examination certificates remain valid – however be aware of changes at time of renewal

Holders of existing AIMD Design Examination / Type Examination certificates shall apply for a complimentary certificate attesting compliance with the Regulation – these must be issued before 29 August 2014

(13)

EU Regulation 722/2012

13

Bovine

Deer

Ovine

Caprine

Elk

Mink

(14)

EU Regulation 722/2012 – Key Considerations

Risks Benefits

Risks Benefits

(15)

Susceptible to transmissible spongiform encephalopathy

Prevention, control & eradication – EU Regulation

999/2001

Nature of Starting Tissue

Tallow Derivatives – EU Regulation 1069/2009

Infectivity – EU Regulation 1069/2009

Geographical Sourcing

World Organisation for Animal Health (OIE) – EU

Regulation 2007/453 – Bovine

European Food Safety Authority (EFSA) – All other

species

(16)

EU Regulation 1069/2009 – Starting Material

Collagen, gelatine and tallow used for the manufacturing of

medical devices shall meet at least the requirements as fit

for human consumption laid down in Regulation (EC) No

1069/2009.

Rigorous Processing – tallow derivatives – EU Regulation

722/2012 not applicable – from MedDev to Regulation

Trans-esterification or hydrolysis – 200 °C >20 minutes

Saponification with NaOH 12 M

— Batch process

— Continuous process

(17)

• Brain, Spinal Cord, Retina, Optic Nerve, Pituitary Gland

High

Infectivity

• Peripheral Nerves, Spleen, Lymph Nodes,

Esophagus, Stomach, Placenta, Lung, Liver, Kidney, Pancreas, Skeletal Muscle, Tongue, Blood Vessels, Cornea, Cerebral Spinal Fluid, Blood

Lower

Infectivity

• Semen, Placenta, Bone, Heart, Tendon, Gingival Tissue, Skin, Adipose Tissue, Saliva, Sweat, Bile, Urine

No Detected

Infectivity

(18)

All Others

Bulgaria, Canada, Croatia, Costa Rica, Cyprus, Czech Republic, Estonia,

France, Germany, Greece, Hungary, Ireland, Korea, Latvia, Lichtenstein,

Lithuania, Luxembourg, Malta, Mexico, Nicaragua, Poland, Slovakia,

Spain, Switzerland, United Kingdom

Argentina, Austria, Australia, Belgium, Brazil, Chile, Colombia, Denmark, Finland, Iceland, India, Israel, Italy,

Japan, Netherlands, New Zealand, Norway, Panama, Paraguay, Peru, Singapore, Slovenia, Sweden, United

States of America, Uruguay

EU Regulation 2007/453 – Geographical BSE Risk

– Bovine

Undetermined

Controlled

(19)

Portugal, UK

Andorra, Albania, Austria, Belarus, Belgium, Canada, Chile, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Israel,

Italy, Latvia, Lithuania, Luxembourg, Malta, Mexico, South

Africa, USA

Botswana, Brazil, Costa Rica, El Salvador, India, Kenya, Mauritius, Namibia, Nicaragua, Norway,

Swaziland, Sweden

Argentina, Australia, Iceland, New Zealand, Panama, Paraguay, Singapore, Uruguay

EFSA – All other species

Likely but not confirmed Unlikely but not excluded

Highly unlikely

(20)

EU Regulation 722/2012

There is no longer an exemption for medical devices using starting materials for which a TSE certificate of suitability has been issued.

However the commenting period for these devices will be shortened

from 12 weeks to 4 weeks.

Submit Dossier Notified Body Review Competent Authority Review Submit Dossier Notified Body Review Competent Authority Review No EDQM Certificate 4 Weeks 12 Weeks

(21)

93/42/EEC - Animal Tissue - Conformity Assessment

1.

• 93/42/EEC ER#8.2 and EN ISO 22442 applicable • 93/42/EEC Rule 17 not applicable

2.

• 93/42/EEC ER#8.2 and EN ISO 22442 applicable • 93/42/EEC Rule 17 applicable

• EU Regulation 722/2012 not applicable

3.

• 93/42/EEC ER#8.2 and EN ISO 22442 applicable • 93/42/EEC Rule 17 applicable

(22)

EU Regulation 722/2012

http://ec.europa.eu/health/medical-devices/documents/index_en.htm

EN ISO 22442-1, -2, -3 & -4

http://www. bsol.bsigroup.com/

MedDev 2.11-1

*see next slide

http://ec.europa.eu/health/medical-devices/documents/guidelines/index_en.htm

http://www.oie.int/

http://www.efsa.europa.eu/en/panels/biohaz.htm

http://www.edqm.eu/en/edqm-homepage-628.html

References

(23)

http://ec.europa.eu/health/medical-devices/documents/guidelines/index_en.htm

Revision 2 – January 2008

Many aspects moved to EU Regulation 722/2012

Need to inform the Notified Body of change

Rigorous Processing

Summary Evaluation Report

Revision 3 – draft is consistent with this presentation

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