A revised standard on medical devices utilizing animal tissues could be available before year-end. The standard is due to be voted on by the European Standardization Organizations CEN-CENELEC on the 10th August and could become effective three months later.
That is good news for manufacturers of medical devices utilizing tissues of animal origin. Current EU regulation imposes an additional compliance requirement intended to reduce the risk of disease transmission from animals to humans, however, due to lack of harmonized standards the assessment procedures can be burdensome. New revision may constitute more adequate conformity assessment procedures.
New revision of ISO 22442
The current standard EN ISO 22442 on medical devices utilizing animal tissues has three distinct parts:
- EN ISO 22442-1:2007 (Medical devices utilizing animal tissues and their derivatives – Part 1: Application of risk management )
- EN ISO 22442-2:2007 (Medical devices utilizing animal tissues and their derivatives – Part 2: Controls on sourcing, collection and handling)
- EN ISO 22442-3:2007 (Medical devices utilizing animal tissues and their derivatives – Part 3: Validation of the elimination and/or inactivation of viruses and transmissible spongiform encephalopathy (TSE) agents)
The undergoing revision regards the EN ISO Standard 22442-1 and EN ISO 22442-2.
ISO 22442-1:2007 applies to medical devices other than IVD devices manufactured utilizing materials of animal origin, which are non-viable or have been rendered non-viable. It specifies a procedure to identify the hazards and hazardous situations associated with such devices, to estimate and evaluate the resulting risks, to control these risks, and to monitor the effectiveness of that control.
ISO 22442-2:2007 specifies requirements for controls on the sourcing, collection and handling (which includes storage and transport) of animals and tissues for the manufacture of medical devices utilizing materials of animal origin, other than IVD devices. It applies where required by the risk management process as described in ISO 22442-1.
Once approved, the standards will give a presumption of conformity with the relevant essential requirements under the Medical Devices Directives and will apply to all devices manufactured utilizing materials of animal origin including those derived from Transmissible Spongiform Encephalopathy (TSE) susceptible species (such as bovine, caprine, deer, elk, feline, mink, ovine).
The EU Regulation 722/2012 on utilizing tissues of animal origin
Due to potential health risks and the politically sensitive nature of using animal tissues in medical devices, the Commission in 2012 issued a specific EU Regulation 722/2012 covering medical devices that use animal tissues. It requires medical device manufacturers whose products utilize tissues of animal origin to carry out the particular risk analysis and risk management procedures before lodging the conformity assessment applications.
Every patient has the right to access safe healthcare nowadays. CEN and CENELEC develop European Standards setting safety, quality and performance requirements for medical devices that are placed on the European market. A great part of the standards enable manufacturers to make their medical products compliant with the European legislation in the medical sector.
Animal tissue standard is just one of the many standards that are forthcoming at CEN/CENELEC. There are several other standards that are mainly new on the Snapshot list, which will be available soon, likely later this year.
If you would like to know more about the ongoing revision of standards on medical devices, please contact us.