New EU Rules on Human Tissues and Cells
On April 8th 2015 the European Commission adopted new rules aimed at ensuring high standards of quality and patient safety regarding human cells and tissues distributed in the European Union.
The new set of rules includes two Directives:
- Directive 565/2015/EU amending Directive 2006/86/EC regarding certain technical requirements for the coding of human tissues and cells; focusing on technical requirements aimed at ensuring the traceability of all tissues and cells distributed across the European Union from donors to recipient and vice-versa.
- Directive 566/2015/EU implementing Directive 2004/23/EC regarding the procedures for verifying the equivalent standards of quality and safety of imported tissues and cells; setting specific requirements for tissues and cells imported from 3rd countries.
Content of the new Directives
The new rules introduce two main traceability tools and fix the requirements for importing and distributing tissues and cells from 3rd countries suppliers:
- The Single European Code (SEC)
This is a unique identifier applied to tissues and cells distributed in the Union and consists of a donation identification sequence and a product identification sequence.
The SEC should be allocated to all relevant tissues and cells before their distribution for human application; it should be affixed in an indelible and permanent manner on the label of the concerned product. The use of SEC shall facilitate traceability while ensuring a uniform labelling system.
- The EU Coding Platform
A publicly accessible IT platform hosted by the European Commission that should contain the full registers of all types of tissues and cells circulating in the Union and the respective product codes.
This platform should improve the accessibility of information and the mutual cooperation across the European Union.
- Accredited importing establishments
All imports of tissues and cells from 3rd countries shall be undertaken by importing establishments accredited, designated, authorised or licensed by a Competent Authority.
The importing establishments must take all the necessary measures in order to ensure that any imports of tissues and cells meet the relevant standards of quality and safety and that imported tissues and cells can be traced from the donor to the recipient and vice versa.
- Inspections and Controls
According to the new Directive, Competent Authorities shall organise inspections and other control measures of importing tissue establishments and of their third country suppliers in order to ensure the equivalency of the quality and safety standards of the tissues and cells to be imported with the standards laid down in Directive 2004/23/EC.
Following the implementation of the new EU Directives, human tissues and cells to be imported from 3rd countries will be subjected not only to higher safety and quality standards, but to stricter rules regarding the distribution and supply chain.
With more than 25 years of experience in product compliance to EU Regulations, Obelis European Authorized Representative Centre is providing a wide range of services to ensure that medical devices and all others healthcare products are compliant with EU Requirements and that these products are safely placed on the market.
If you would like to know more on product safety and post-market surveillance, contact us!