The Weekly Pulse: 6th March – 10th March

What’s HOT in our Regulatory World

What are our clients looking at?

This week’s trending sources in C2P

• North Carolina (USA): Stewardship Program for Packaging and Ban of Certain Toxic Substances in Packaging Materials, House Bill 279, 2023
• EU: 2023 Annual Union Work Programme for European Standardisation, Notice, February 2023
• Brazil: Electromagnetic Compatibility Technical Requirements for Conformity Assessment of Products, Public Consultation No. 10, March 2023

What is our Content Team talking about?

UK proposes Data Protection and Digital Information (No. 2) Bill – Ani Nozadze

On 8 March 2023, the UK Secretary of State for Science, Innovation, and Technology, Michelle Donelan, introduced the Data Protection and Digital Information (No. 2) Bill to the UK Parliament. As the name suggests, this is the second set of proposals to amend the UK Data Protection Act 2018. The first set of amendments, introduced in July 2022, was paused in September 2022 and will not be proceeding.

The UK Government has mentioned in its press release that “the improved bill will:

• introduce a simple, clear, and business-friendly framework that will not be difficult or costly to implement – taking the best elements of GDPR and providing businesses with more flexibility about how they comply with the new data laws
• Ensure [the] new regime maintains data adequacy with the EU and wider international confidence in the UK’s comprehensive data protection standards
• Further reduce the amount of paperwork organizations need to complete to demonstrate compliance […]
• Provide organizations with greater confidence about when they can process personal data without consent
• Increase public and business confidence in AI technologies by clarifying the circumstances when robust safeguards apply to automated decision-making”

Some notable changes include:

• increased fines for nuisance calls and texts – either up to 4% of global turnover or £17.5 million, whichever is greater;
• a list of activities that can be regarded as in the data controller’s legitimate interest; the list includes but is not limited to:

-processing that is necessary for the purposes of direct marketing

-intra-group transmission of personal data where necessary for internal administrative purposes

-processing necessary to ensure network and information systems security;

• updated (non-exhaustive) definition of scientific research which can allow commercial organizations to benefit from the same freedoms as academics to carry out innovative scientific research;
• the obligation to keep records of processing activities will apply only to those organizations whose processing activities are likely to result in a high risk to an individual’s rights and freedoms; high risk is assessed by taking into account the nature, scope, context, and purposes of the processing;
• removal of the requirement for controllers and processors not established in the UK to appoint a UK representative;
• replacing provisions regarding data protection officers (DPO) with provisions on senior responsible individuals (SRI). SRIs will only be required to be appointed in public bodies or those controllers/processors that carry out processing likely to result in a high risk to individual’s rights and freedoms; 
• data protection test to be met to make regulations approving transfers to a third country or international organization – the standard of protection to be considered in a holistic way while assessing whether the standard is materially lower than the UK’s standard (which it should not be).

What are our Knowledge Partners talking about?

The Future Medical Device Regulations Within The UK – Kennedys

Introduction

In the UK, medical devices are currently regulated under the Medical Devices Regulations 2002 (“MDR 2002”), which gave effect in UK law to the following EU Directives (which have since been repealed and replaced at EU level): 

• Directive 90/385/EEC on active implantable medical devices;
• Directive 93/42/EEC on medical devices;
• Directive 98/79/EC on In Vitro Diagnostic (IVD) medical devices.

Following the UK’s exit from the EU and the sweeping reform of the medical device regime currently being undertaken at an EU level (more detail can be found here), the MHRA has noted that there is now a unique opportunity for the UK to review the MDR 2002 (which is based on EU retained law) and improve how medical devices and IVD medical devices are regulated in the UK post-Brexit.

As part of this, the Medicines and Medical Devices Act 2021, which came into force on 11 April 2021, vests power in the MHRA to allow them to make amendments to the existing regime in the UK, the MDR 2002.

The Consultation

As a first step, on 16 September 2021, the MHRA published a consultation seeking the views of patients, medical device researchers, developers, and manufacturers to help shape future regulations on medical devices. The MHRA’s response to the consultation, which as noted above was published on 26 June 2022, confirmed that the UK’s future Medical Device Regulations will be based on the following five “pillars”:

• Strengthening the MHRA’s powers to ensure that patients are kept safe;
• Making the UK a focus for innovation, in particular in respect of developing and introducing innovative medical devices;  
• Addressing health inequalities and mitigating biases throughout the medical device product lifecycle;
• Building synergies with both EU and global standards through the use of proportionate regulation which supports businesses; and
• Setting world-leading standards – Building the UKCA mark as a global exemplar.

In conjunction with the above, the MHRA announced on 25 October that the UK’s future Medical Device Regulations will likely be in force by July 2024; following a 12- month extension to the original implementation deadline. This extension is seen to allow time for both the industry and regulator alike to prepare for what are significant regulatory changes for the life sciences industry without compromising the safe supply of medical devices in the UK. We currently await the draft text of the UK’s future Medical Device Regulations and will comment further upon receipt of the same. 

(For the full commentary, please go to C2P.)

What are our clients asking about?

“Are spectacle frames and sunglasses considered medical devices in the Philippines?” 

Answer by  Denise McDermott

According to Philippines: List of Class A Medical Devices, Circular No. 2021-017, which aims to guide manufacturers regarding the list of medical devices classified as Class A and to help the industry to determine the appropriate authorization, under Section J – Ophthalmic devices, ‘lens, spectacle (prescription), for reading discomfort’, ‘lens, spectacle, non-custom (prescription)’, ‘lens, prescription, color deficiency’, and ‘sunglasses (with grade)’, are all listed.

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This information is based on the most viewed regulations on C2P this month.

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