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UK MHRA consults on no-deal Brexit legislation

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has initiated a consultation on the legislation and regulatory processes for medicines, medical devices and related...

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Publication of the notified bodies’ designation codes under the MDR and IVDR

The European Commission’s Implementing Regulation concerning the list of codes defining the scope of designation of notified bodies under the Medical Devices Regulation...

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Excessive pricing in pharmaceutical products attracts the European Commission’s attention

In recent years competition authorities in a number of EU Member States have stepped up in their pursuit against companies active in the Life Sciences sector for excessive pricing. Last...

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The MHRA issues new guidance concerning own brand labelling or "virtual manufacturing"

On 29 March 2017, the UK Medicines and Healthcare products Regulatory Agency (MHRA) published a new guidance (hereafter “Guidance“) concerning the Own Brand Labelling of medical ...

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Medical Device Alert – Finalised texts of the new EU Regulations on medical devices and in-vitro diagnostic medical devices are out

On 22 February 2017, the Council of the European Union issued the final versions of the draft texts of the European Union (“EU”) Medical Device Regulations (“MDR”)...

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New Belgian Sunshine Requirements applicable to all pharmaceutical and medical devices from 1 January 2017

On 27 December 2016, the Belgian Law of 18 December 2016 concerning various health-related matters (“the Sunshine Act “) was adopted by the Belgian Ministry for Public...

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France imposes an extra notification obligation on Class III and implantable medical devices manufacturers

On 13 December 2016, the French Decree 2016-1716 implementing the French Law 2016-41 modernising the French healthcare system (“French Law 2016-41”) was adopted. This Decree...

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