How Are New Regulations Impacting European Life Sciences?

In the EU in particular, there is an anticipated wave of legislative changes in 2023, many of which have been a result of (or catalysed by) the pandemic, which emphasised the need for modernising pharmaceutical law and regulations across the industry.

Artificial intelligence (AI) has also factored significantly in these changes as the EU looks to regulate its use.

But how are new regulations impacting European life sciences, and how might these changes influence the way that current life sciences businesses are operating?

Let’s take a look.

Transition to EU Medical Devices Regulation (EU MDR)

Though the EU MDR became applicable back in May 2021, there is still a transitional period in which medical device manufacturers are given time to transition from IVDR to the newer regulation, which is required by May 2024.

The regulation of the medical device industry in Europe has, up until recently, been fairly unchanged since the 1990s, yet there is now a push to reform the industry in the wake of incidents such as the breast implant crisis.

The primary aim of the ED MDR is to ensure patient safety, increase transparency and product traceability, and harmonise laws relating to medical devices within the EU.

Companies will now need to make a significant number of changes to technical documentation for products and existing processes in their quality management systems (QMSs) to ensure compliance.

Other key areas of note for medical device organisations include:

• Companies undergoing the transition will need to revisit their core processes (e.g., quality assurance and risk management) as well as postmarket expectations.

• On 26 May 2024, all MDD certificates will become void, which is why swift action is essential.

• The deadline for high-risk in vitro diagnostic devices is the 26th May 2026, whereas lower-risk devices have until the 26th May 2027 to transition.

• More information can be found here.

EU Clinical Trials Regulation

Entered into application in January 2022, the EU pharmaceutical legislation (also known as the Clinical Trials Regulation) aims to ensure the EU offers a favourable environment for carrying out clinical research on a large scale.

Public transparency and safety for trial participants are central to this legislation, which looks to harmonise the processes for the assessment and supervision of clinical trials throughout the EU.

Before the Regulation, clinical trial sponsors submitted clinical trial applications separately to national competent authorities and ethics committees in each country to gain regulatory approval.

Under the Regulation, sponsors are able to submit one online application via a single online platform known as the Clinical Trials Information System (CTIS) for approval to run a clinical trial in several European countries, making the process more efficient.

One of the biggest benefits of the Regulation is that larger clinical trials in multiple EU Member States can be conducted, and information-sharing and collective decision-making on clinical trials is far more streamlined and efficient.

Clinical trial sponsors can already use the CTIS, but there is no obligation to do so immediately as there is a three-year transition period (from 31st January 2022).

More information can be found here.

EU Pharmaceutical Legislation Reform

The European Commission has proposed updates that aim to address numerous shortfalls in the European pharmaceutical industry.

These updates are the most significant revisions to the EU’s pharmaceutical legislation in 20 years, and as with many other areas of legislation that are being revised and updated, there is an aim to make medicines more available, accessible and affordable. 

This reform will replace the general pharmaceutical legislation and the legislation on medicines for rare diseases and children. However, these changes need to be approved by the EU parliament, so there is no set date in place for these changes as of yet.

Though many of the changes proposed in the reform are positive and aim to address outdated legislation, particularly the areas that were highlighted during the pandemic, the proposals still have to advance through the commission’s regulatory process.

You can find out more here.

Regulatory framework to govern artificial intelligence 

The European Commission has proposed a novel regulatory framework to govern AI, including a Regulation establishing harmonised rules on AI (AI act) and a Directive adapting non-contractual civil liability rules to AI (AI Liability Directive).

The requirements in the proposed AI Act are inspired in part by the regulation of medical devices and data privacy, with an emphasis on extensive risk management for the riskiest forms of AI.

This would include the:

• Requirement to undergo conformity assessments

• Drawing up and maintenance of technical documentation

• Implementation of quality management systems

• Affixing of CE-markings to indicate conformity with the Commission’s proposed regulation before products are released to market

Though the proposed regulatory framework has wide-ranging applicability to AI providers both inside and outside of the EU, for life sciences companies in particular, there is likely to be a push towards putting resources in place sooner rather than later, if and when this regulation comes into effect.

Preparation is key

Regulatory changes require awareness and strong preparation – even when regulations have a transition period, it is better to prepare sooner rather than later.

Good record keeping and evidence of following procedures will be essential, as will ensuring that your processes are compliant across the board.

Get in touch

Staying ahead of regulatory changes by choosing a recruitment partner that keeps your organisation informed and agile is critical, especially given that up-and-coming technologies will continue to influence the necessity for change.

Panda is trusted by leading life sciences companies worldwide to provide the very best contingent talent and deliver seamless candidate experiences.

For more information on regulatory changes in life sciences and what we can do for your organisation, get in touch today.