New EU medical device packaging regulations are due in just over a year. The new revision help medical device manufacturers conform with the new general safety and performance requirements.
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The new incoming EU Medical Device Regulations are just over a year away. Check our the below advice to help medical device manufacturers conform with the new safety and performance requirements.
For those involved in Medical Device Packaging these days they have a lot of rules and regulations to abide by. There are even more on the way despite the latest revision of the ‘packaging for sterilized medical devices’ only being published last year.
This is essentially a guide for applying the rules and regulations surrounding ISO 11607. Now there is a new installment as of February 2019.
These revisions are one of many regulatory changes that are happening around the globe. The latest revision is to help prepare companies for the new European Medical Device Regulations (EU MDR) being introduced this year.
Many of the regulatory changes taking place around the globe are based on the essential principles stated at the International Medical Device Regulators Forum (IMDRF).
The principles decided on here are published under the ISO 16142: 2016 regulations titled ‘Medical Devices – Recognized essential principles of safety and performance’. In the EU MDR they are known as the General Safety & Performance Requirements or GSPR. In the future harmonized standards will be needed to ensure conformity.
Among the requirements set in ISO 11607-1:2019 are changes to the sterlie barrier packaging films and systems themselves.
Under ISO 11607-2:2019 changes include changes to validatable heat sealers as well as the assembly processes involved.