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In Antitrust / Competition

Mexico: COFECE initiates a competition analysis into the digital financial services market

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On 22 June 2022, the Commissioners of the Federal Economic Competition Commission (COFECE) approved conducting a research study on competition in the digital financial services market. The Market Study’s purpose is to analyze the structure, operation and regulatory framework of the digital financial services sector in Mexico.
The digital financial services considered in the study include electronic payment and crowdfunding services, those offered by Financial Technology Institutions, also known as Fintech, which are regulated by the Law to Regulate Financial Technology Institutions.
According to COFECE, the Market Study is important because the financial services sector contributes a significant percentage of the country’s Gross Domestic Product, and digital financial services can also influence the financial options available to users and facilitates credit access to small and medium-sized companies.

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In Product Regulation & Liability

Italy: Bills to implement Regulation (EU) 2017/745 and Regulation (EU) 2017/746 on medical devices and in vitro diagnostic medical devices

by and 2 Mins Read

On 5 May 2022, the Council of Ministers preliminarily approved the bill to adapt the Italian legislation to the provisions of Regulation (EU) 2017/745 on medical devices and Regulation (EU) 2017/746 on in vitro diagnostic medical devices. The bills are currently being examined by the competent committees of the Italian Parliament.

In Product Regulation & Liability

Italy: Regulation (EU) 2017/746 on in vitro diagnostic medical devices applies

by and 2 Mins Read

From 26 May 2022, Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) has applied.
• The main changes introduced by the IVDR include (i) a new classification of devices, (ii) new conformity assessment procedures that differ according to the risk class and the specific characteristics of the device, (iii) reinforced requirements relating to clinical evidence aimed at demonstrating compliance with the safety and performance requirements of the device, (iv) the introduction of post-marketing follow-up obligations for manufacturers aimed at updating the performance evaluation throughout the life cycle of the device, (v) the provision of new obligations for manufacturers, authorized representatives, importers and distributors, and (vi) the obligation for manufacturers to appoint a person responsible for regulatory compliance.

In Antitrust / Competition

Italy: The changes provided by the Competition Bill 2021 on the production of blood-derived drugs

by and 2 Mins Read

The bill on the “Annual Market and Competition 2021”, approved by the senate on 30 May 2022 and currently under examination by the Chamber of Deputies, provides for the amendment of Article 15 of Law No. 219/2005, governing the Italian transfusion system and the production of blood-derived medicines.

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In ESG

European Union: Coming Up Next – European Commission’s 2020 pharmaceutical strategy – an overhaul of pharmaceutical legislation

by and 2 Mins Read

A revision of EU pharmaceutical legislation by the European Commission will be published on 21 December. These revisions indicate the execution of the European Commission’s 2020 Pharmaceutical Strategy – a strategy that seeks to create a more resilient regulatory system in light of the COVID-19 pandemic.

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In Product Regulation & Liability

UK: Is the UK set to become an even bigger international player in medicinal and medical device regulation

by 2 Mins Read

The MHRA has been accepted as a full member of three groups: the International Medical Device Regulatory Forum (IMDRF), the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) and the US-based Medical Devices Innovation Consortium. These partnerships bolster the MHRA’s position as an influential international player in medicinal and medical device regulation and restore the MHRA’s ties with the IMDRF and ICH.

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