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Season's Greetings!

Clinius Team

We have donated Seasons Greetings’ funds to the Association of Friends of the University Children’s Hospitals.

MEDDEV guidance on Clinical Evaluations has been updated (MEDDEV 2.7.1 rev. 4). The guidance is clearly more extencive than previously, but includes also guiding how to apply it. Notified Bodies, in our experience, are getting more active on this.

The European device regulation is changing! The European Parliament has approved  the new regulation regarding medical devices and  IVD devices on May 4th 2017. As the European Council has accepted regulations earliert, these will come into effect presumably by June. The transition period on medical devices is 3 years and on IVD devices 5 years.

New regulations are to modernize and strengthen legislation, to improve market surveillance and traceability, and to ensure that the design of all medical devices and IVD devices take into account the latest scientific and technical developments. The objective of the new regulation is to:

• improve the quality, safety and reliability of medical devices: Control is tightened with regard to clinical trials. The new rules also cover a number of previously unregulated aesthetic products. In addition, the IVD devices need to comply with new risk based classification guidelines;
• increase the transparency of information provided to consumers: Key product information is easy to find in the future. Further, each product is provided with a unique identifier (UDI), with which it can be found on the new European medical device database (EUDAMED);
• increase market surveillance: manufacturers must collect information on the functionalityof their equipment placed on the market. EU countries must more closely coordinated their market surveillance activities.

Merry Christmas and a Happy New Year!

God Jul och Gott Nytt År!

This year we donated the card funds to the Association of Friends of the University Children's Hospital.
Detta år begåvade vi julkort pengar till Barnkliniernas Faddrar rf.