EU: MDCG 2024-10 - Clinical evaluation of orphan medical devices - August/September 2024
- 2024-09-17 05:23:25
This guidance offers instructions on the clinical evaluation of orphan devices under the MDR.
MoreThis guidance offers instructions on the clinical evaluation of orphan devices under the MDR.
MoreEarlier in January 2020, MDA had released a revised Circular Letter No. 2 Year 2018, on the control of orphaned, obsolete and discontinued medical device healthcare and related facilities. There have been some revisions introduced to the definition of types of medical devices covered in this circular letter.
MoreThe number of registered medical devices which become obsolete and get discontinued and become orphaned are increasing in Malaysia with no policy in place to control them to meet requirements in accordance with the purposes of this Act.
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