The government has announced that it is proposing to make changes to trade union law that will remove the current prohibition on businesses using temporary workers to cover staff taking part in industrial action. It has also announced that it plans to quadruple the maximum amount of damages that a court can award against a trade union for unlawful strike action from GBP 250,000 to GBP 1 million. These changes will need to be approved by Parliament.
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.
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.
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.
On 20 June 2022, the new national pharmacovigilance network, which ensures the collection, management and analysis of suspected adverse reaction reports of medicines in Italy, became operative.
With Judgement No. 3278/2022, the Council of State confirmed the legitimacy of the decision by which the Italian Medicine Agency declared the forfeiture of an MA for failure to market the drug pursuant to Article 38, paragraph 7 of Legislative Decree No. 219/2006.
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.
Medical device companies anticipating new rules post-Brexit may be feeling somewhat overlooked to hear the BEIS’s recent announcement regarding UKCA marking. From this announcement, it transpired that the UKCA marking announcement did not include medical devices and in-vitro medical devices.
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.
The European Recovery Plan will pump EUR 750 billion into the economy in the relative short term, with nearly half earmarked for climate change and digital investment. This funding will support the transformation to greener, more digital, sustainable and resilient economies, and businesses active across the EU will be able to benefit.