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.
Baker McKenzie’s Sanctions Blog published the alert titled Ukraine: the law on canceling marketing authorizations due to ties with Russian/Belarusian pharmaceutical manufacturing became effective on 20 June 2022. Read the article via the link here. Please also visit our Sanctions Blog for the most recent updates.
Baker McKenzie’s Sanctions Blog published the alert titled Japan introduces further sanctions against Russia and Belarus on 20 June 2022. Read the article via the link here. Please also visit our Sanctions Blog for the most recent updates.
Manufacturers and EU importers of medical devices are periodically confronted with new sets of rules imposing new product conformity requirements. Apart from MDR/IVDR, other EU legislation as well as revisions of ISO standards may compel companies to secure future marketability of legacy products on stock before the expiry of transition periods. To take advantage of transition mechanisms, EU legislators regularly require that affected products have to be “placed on the market” prior to a cut-off date. But what does that mean, and how should companies practically implement and record a “placing on the market”?
On 23 June 2022, the Bundestag passed a bill to implement the Working Conditions Directive (EU) 2019/1152. This is intended to create transparency and predictability of working conditions and improve them overall. The law is expected to enter into force on 1 August 2022.
Please note that this event will be held in German only.
Environmental sustainability, social justice and proactive corporate governance will increasingly underpin the ESG agenda in the real estate sector for investors, occupiers and stakeholders alike. Buildings are responsible for almost 40% of global greenhouse gas emissions, meaning our industry clearly has work to do if the UK is to achieve net-zero by 2050. The terms “net-zero” and “greenwashing” do not sit well together, and if the former is to win out, the UK will need an ambitious regulatory framework, coupled with unwavering buy-in from the boardroom to the living room. “Action, not aspiration” is the UK government’s message.
In June 2022, the governments of Belgium’s nine federated entities agreed on the text of a cooperation agreement implementing a screening mechanism of general application for foreign direct investments into Belgium. The screening mechanism is expected to enter into force on 1 January 2023. The Cooperation Agreement is inspired by EU Regulation 2019/452 of the European Parliament and of the Council of 19 March 2019 establishing a general framework for the screening of foreign direct investments into the Union. Belgium is now set to become the 19th EU Member State with a screening mechanism for foreign direct investments.
In a briefing published by Regulatory Intelligence, Annabel Mackay and Samantha Pickett explain the importance of cultivating an ethical culture from a financial regulatory, employment law and employee engagement perspective, and suggest how leaders can use communication strategies to do so.