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Drug shortage, EMA actions to contain pandemic crisis

The emergency situation generated by the spreading of the COVID-19 contagion is having a relevant impact on health systems, not only in...

New edition for the EN ISO 14971: what impact for MD manufacturers?

In spite of the proposal to postpone the full adoption of the medical device Regulation 2017/745 (MDR) currently under discussion, manufacturers should...

How post-market surveillance changed from the Directive to the Regulation

Although already present in Directive 93/42/EEC on medical devices (DM), the concept of post-market surveillance (surveillance, ed.) is considered one of the most critical...

Food labelling

The regulation on food labelling, entered into force many years ago, is certainly one of the reference regulations for the food...

Always check disinfectants labelling

In the difficult moment of health and economic crisis we are living, unfortunately we should also pay attention to the...

Roles and responsibilities of authorised representatives, importers and distributors

Roles and responsibilities of authorised representatives The general obligations of authorised representatives are described in article 11 of the MDR and...

Food supplements from formulation to sale

The market of food supplements does not seem to have entered any crisis. Actually, this sector shows steady – if not growing...

What is the appropriate classification of disinfectants?

In this difficult time of health emergency linked to the spreading of the COVID-19 virus, the demand of disinfectant products is becoming...

Covid-9 emergency: the European Commission works on proposal to postpone Reg. (EU) 2017/745 application of one year

On 25 Mach 2020, in full Covid-19 emergency, a note was released by the European Commission where they announced they...

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