Current In Medical Devices
DOA gets closer! What does it mean? What changes?
The requirements for clinical evaluation applies also for Class I Medical Devices. Clinical evaluation involves the assessment and analysis of clinical data pertaining to a medical device to verify the clinical safety and performance.
Manufacturer is responsible for clinical evaluation and keeping it up-to date and ensure proactive post market surveillance. The clinical evaluation report is an element of the technical documentation of a medical device.
Transition time for Medical Devices
The transition period is fully described in MedTech Europe web site. MedTech Europe represents Diagnostics and Medical Devices manufacturers operating in Europe.
Date of Application 2020 May 26th: All new Class I Medical Devices must fulfill the requirements of the Regulation 2017/745. In other words; it is not possible to place to the market a new Class I Medical Device product that fulfills the requirements of the Directive 93/42 anymore. However, it is allowed to keep the old (according to directive 93/42) products in the market, and produce new batches of it, and continue marketing it; if no significant changes are done to them.
< Note! Products certified by Notified Body (NB) according to directive 93/42 /EEC (Class II-III products) can be placed on the market and remain saleable as long as the Notified Body certificate is valid. New batches can be manufactured, and marketing activities can continue if no significant changes are made to the product and if NB certificate is valid (not expired).
2024 May 27th: Latest expiry date for NB certificates issued according to MDD 93/42. After NB certificate expiration: batches are not allowed to leave the manufacturing facilities after that. Products already in the supply chain remain saleable.
< Note! The NB certificate for individual product can expire earlier.
2025 May 27th: Recall from the market all products that are certified according to MDD 93/42/EEC.