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Focus On Regulation

Publication of further guidance on the role of the “UK Responsible Person” in case of no-deal Brexit

On 18 September 2019, the United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA) published new guidance regarding the role and responsibilities of the “UK...

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New MDCG Guidance on Summary of Safety and Clinical Performance under the Medical Devices Regulation (MDR)

On 26 September 2019, the European Commission published a new Guidance of the Medical Device Coordination Group (MDCG) concerning the Summary of Safety and Clinical Performance (SSCP). This ...

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The European Commission has published Guidelines concerning the use of phthalates in medical devices

The European Commission’s Scientific Committee on Health, Environmental and Emerging Risks (SCHEER) has published Guidelines concerning the use of phthalates in medical devices.

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New drug marketing applications: how do EMA and FDA compare?

A newly-published study has compared more than a hundred new drug marketing applications at both the European Medicines Agency (EMA) and the Food and Drug Administration (FDA) in the period ...

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Publication of rules on designation of expert panels under the Medical Devices Regulations

In the process of getting ready for the implementation of the forthcoming medical devices Regulations the European Commission published on 10 September 2019 the Commission Implementing...

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