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Between mdd and mdr: class i medical devices

Medical devices (MD) can be marketed only if complying with the relevant essential requirements described in annex I of Directive 93/42/EEC (MDD). In...

How to store narcotics and how to fill in the paper narcotic registry

Except for special cases, narcotic and psychotropic drugs should be stored in a cabinet or container that cannot be removed, and locked...

How to manage the incoming/outgoing narcotic information registry

Handling of narcotic and psychotropic substances, including medicines and relevant compositions containing such substances, can be recorded either on paper or...

How to evaluate cosmetic safety in the EU

As this is a European Regulation, the obligations provided in it apply to all countries of the European Union. This...

How to obtain CE marking for contact lenses

Contact lenses – either soft, hard or semi hard – are a valid alternative to the daily use of glasses....

Certificazione CE

CE marking, what it is and what it is not

Understanding the complex sector of medical device is becoming more and more difficult, both for the moment of transition between the directives...

Food supplements: a reminder on notifications

More and more frequently the Italian authority is requesting that food supplements are withdrawn from the market. The Italian task force against...

More controls in the EU market for hazardous mixtures, including biocides

The “Forum for Exchange of Information on Enforcement” has started the REF-8 project to control online sold products. The Forum is formed...

The clinical evaluation of medical devices in view of Regulation EU 745/2017: are we ready?

The date of application of Regulation EU 745/2017 (hereafter MDR, 26 May 2020) is close and Medical Device (MD) manufacturers shall be...

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