Commission Regulation (EU) No 722/2012 of 8 August 2012 concerning particular req... (32012R0722)
Commission Regulation (EU) No 722/2012 of 8 August 2012 concerning particular requirements as regards the requirements laid down in Council Directives 90/385/EEC and 93/42/EEC with respect to active implantable medical devices and medical devices manufactured utilising tissues of animal origin Text with EEA relevance
- COMMISSION REGULATION (EU) No 722/2012
- of 8 August 2012
- concerning particular requirements as regards the requirements laid down in Council Directives 90/385/EEC and 93/42/EEC with respect to active implantable medical devices and medical devices manufactured utilising tissues of animal origin
- (Text with EEA relevance)
- Article 1
- Article 2
- Article 3
- Article 4
- Article 5
- Article 6
- Article 7
- Article 8
- Article 9
- ANNEX I
- 1. RISK ANALYSIS AND RISK MANAGEMENT
- 1.1.
- Justification for the use of animal tissues or derivatives
- 1.2.
- Process of risk assessment
- 1.2.1.
- Animals as a source of material
- 1.2.2.
- Geographical sourcing
- 1.2.3.
- Nature of starting tissue
- 1.2.4.
- Slaughtering and processing controls to prevent cross contamination
- 1.2.5.
- Inactivation or removal of TSE infectious agents
- 1.2.6.
- Quantities of animal tissues or derivatives required to produce one unit of the medical device
- 1.2.7.
- Tissues or derivatives of animal origin coming into contact with the patients and users
- 1.2.8.
- Route of administration
- 1.3.
- Review of the risk assessment
- 2. EVALUATION BY NOTIFIED BODIES
- 2.1.
- Information of the Notified Body regarding changes and new information
- 2.2.
- Renewal of certificates
- 2.3.
- Increase of the overall TSE risk
- 3. RIGOROUS PROCESSES FOR TALLOW DERIVATIVES AS REFERRED TO IN ARTICLE 1, PARAGRAPH 4, OF THIS REGULATION
- ANNEX II
- Summary Evaluation Report in accordance with Article 5(4) of Regulation (EU) No 722/2012
- Details relating to the submitting notified body
- Data relating to the (active implantable) medical device
- 13. Starting material
- Notified Body Statement
- Date of submission
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