The European Medical Device Regulation (EU MDR) and In Vitro Diagnostic Regulation (IVDR) officially took effect on May 26, 2021, and May 26, 2022, respectively. Like any new regulations, their implementation came with their own unique challenges. Despite the grace period meant to help manufacturers and Notified Bodies (NBs) adjust, Medical Device Companies and NBs faced delays and obstacles that were unavoidable.
Although these regulations have brought meaningful improvements to the industry, the path hasn’t been easy. Over time, the regulatory landscape has evolved significantly. With a wave of updates, new guidance documents, critical clarifications, and invaluable lessons learned, organizations like Elexes have empowered clients to navigate the complexities of the EU MDR and IVDR regulations. These efforts ensure smooth compliance while keeping businesses ahead of the curve.
In this article, we’ll take a deep dive into the key updates and groundbreaking developments that have reshaped the industry since these transformative regulations came into force. Read further for these insights that will help you adapt, excel, and thrive!
Understanding CE Marking: A Quick Overview of what has happened in 2024
In 2024, Notified Bodies (NBs) and EU Authorities faced a range of challenges and successes under the EU Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR). To address many of the challenges, several updates came in. These updates aim to ensure patient safety while allowing manufacturers to transition smoothly to the EU MDR and EU IVDR. Below, let’s take a look at these updates.
1. Extended Transition Periods:
According to the new regulations (EU) 2024/1860 for legacy in vitro diagnostic devices (IVDs), the transition periods for the class D devices have been extended until Dec 2027 and Class C until December 2028, and Class B and sterile Class have been extended till December 2029.
2. EUDAMED Rollout:
The European Database on Medical Devices (EUDAMED) is rolling out step by step, with crucial components set to become essential by the end of 2025.
This revolutionary database will serve as a centralized hub for information on medical devices and in vitro diagnostics (IVDs). Its implementation promises to bring:
a) Unmatched transparency for everyone involved
b) Easy access to critical data for manufacturers and regulators
c) Stronger oversight to ensure devices are safe and compliant
As this game-changing database takes shape, it’s set to make the industry more connected and informed than ever before.
Manufacturers should get ready for the impact—it’s going to be big!
3. Supply Chain Transparency:
New regulations oblige producers to alert authorities and economic operators in advance of any anticipated supply disruptions for vital devices. This adjustment is intended to reduce risks to patient safety owing to device shortages.
4. Legacy Device Conformity
Manufacturers of IVDD-compliant devices must submit conformity assessment applications to recognized authorities by specified timeframes (for example, May 2025 for Class D devices). These applications must be accompanied by agreements within four months.
5. New amendment related to CE Marking adapted by UK government:
As we know, after Brexit the UK government is not a part of the European Union, therefore the UK has introduced a new compliance mark for the UK market, followed by the transitional period ending on 31 Dec 2024, giving manufacturers and importers time to implement these new regulations into their business operations.
This new legislation covers recognition of the most common EU directives, including:
a) Directive 2011/65/EU, which restricts the use of specific hazardous compounds in electrical and electronic equipment
b) Eco-design specifications for energy-related products (including all implementing regulations for particular product groups developed under this Framework Directive and Directive 2009/125/EC)
c) Electrical devices made to operate within specific voltage ranges (Directive 2014/35/EU) and (Directive 2006/42/EC) Machinery
d) Compatibility with electromagnetic fields (Directive 2014/30/EU)
e) Instruments of measurement (Directive 2014/32/EU)
f) Weighing devices that are not automated (Directive 2014/31/EU)
g) Radio apparatus (2014/53/EU Directive)
h) Equipment for applying pressure (Directive 2014/68/EU)
i) Systems and equipment designed to be used in potentially explosive environments (Directive 2014/34/EU)
The positives and the negatives of the EUMDR and IVDR
Impact of EU MDR and EU IVDR on CE Marking Processes
The new CE marking procedures have been a mixed bag of emotions for both the medical device companies and the NBs. Nevertheless, the EU’s Medical Devices Regulation (MDR) and In Vitro Diagnostics Regulation (IVDR) have greatly influenced CE Marking processes, especially with its revisions and extended deadlines into 2024 and beyond. Here are the main effects:
Prolonged Transition Times:
As stated briefly above and detailed out below, the MDR and IVDR compliance deadlines for outdated devices have been extended.
- The IVDR compliance deadline is December 2027 for some Class IIb devices and high-risk Class III devices.
- The new deadline is December 2028 for other devices, including those that have been up-classified as Class I devices under the MDR.
This extension guarantees continued device availability while giving manufacturers more time to satisfy strict conformance requirements as per the IVDR and MDR (Annex 10 – Conformity assessment based on type – examination) to obtain the CE certificates in accordance to the (Annex 12 – Certificates issued by a notified body of the EU IVDR and EU MDR)
Elimination of the Sell-off timeframe:
The sell-off clause, which placed restrictions on the number of devices that might be sold under the previous guidelines, has been eliminated.
Notified Body Agreements:
Manufacturers must apply for conformity assessment with a Notified Body by May 26, 2024, and sign agreements by September 26, 2024. This ensures a structured transition while addressing the backlog of certification applications as per Annex 11 – Conformity assessment based on production quality assurance and Annex 12 – Certificates issued by a notified body of the EU IVDR and EU MDR.
Harmonized Standards:
Updated standards now emphasize safety, performance, and risk management. This aligns with stricter clinical and post-market surveillance requirements under MDR and IVDR, demanding more robust technical documentation in accordance with the regulations, specifically Annex 10 – Conformity assessment based on type – examination and Annex 12 – Certificates issued by a notified body of the EU IVDR and EU MDR.
Global Ripple Effect:
The EU’s MDR and IVDR are setting the standard worldwide, with countries like Switzerland, the UK, and Israel adapting their regulations to align with these benchmarks. For example, the UK will accept CE-marked devices under MDR/IVDR until June 2028, showing just how far the EU’s influence reaches.
Transition Timelines: For MDR
Updates to Testing Requirements for MDR and IVDR Compliance - 2024
Testing has always been an integral part of obtaining a CE certification, but now as per the EU MDR and EU IVDR, the testing and data requirements have gone up a notch. Let’s explore what’s expected now with the new EU MDR and EU IVDR.
1. Clinical Performance and Safety Testing
The new EU MDR and EU IVDR demand strong evidence to demonstrate that medical devices and diagnostic tools are both safe and effective. For high-risk devices, like Class III implants, this means conducting full fledged clinical studies. It is evident that these Diagnostic tools, such as at-home test kits, must undergo performance studies to prove their accuracy and reliability. Manufacturers need to ensure these devices consistently provide the right results, minimizing risks to users.
The Founder of Elexes, Ms. Parul Chansoria, a Regulatory and Quality Expert states that “Now, every claim needs to be supported by evidence. The nature and extent of the evidence shall depend on the risk and the classification of the device. We can no longer rely on testimonials or old data from other global markets. The technologies have evolved a lot and so should the evidence supporting it!”
2. Biological and Chemical Testing
As per the EU MDR and EU IVDR, the devices that come into contact (direct or indirect) with the human body face stricter rules. The ideal device should not only solve respective health problems but also has to make sure that when used on a long-term basis they do not pose any challenges like toxicity, allergic reactions, and potential carcinogenicity. Substances like phthalates are under closer scrutiny. Manufacturers must prove that their materials meet these highest safety standards.
3. Usability Testing
The MDR and IVDR emphasize real-world usability testing to prevent potential user errors. This is especially crucial for medical devices like infusion pumps or self-administered test kits, where it is not only about designing the device that works but also having to make sure it can be safely handled in the hands of users, where user mistakes can have life-threatening consequences. This is also important for many Over-the-counter (OTC) devices.
4. Sterilization and Packaging Validation
Devices that require sterilization, such as surgical instruments, must have their packaging validated to ensure it remains intact over time. Contamination risks are taken very seriously under the EU MDR and EU IVDR regulations. Additionally, sterilization processes (e.g., steam, gamma rays, or ethylene oxide gas) must be tested and revalidated repeatedly to meet the stricter standards.
5. Software and Cybersecurity Testing
In an era of connected devices, cybersecurity is a top priority, as we can only trust secured connections. Devices with software must prove they can resist hacking attempts and protect sensitive patient data. Manufacturers need to think about challenges and vulnerabilities from day one regarding updates to software, and also do rigorous tests to ensure they don’t compromise performance or reliability. With the increase in the influx of connected devices, cybersecurity is now more important than ever.
6. Environmental Testing
Devices must be tested to withstand real-world conditions, including temperature extremes, humidity, and physical impacts like being dropped.
Why These Changes Matter
The stricter rules under MDR and IVDR are designed to make medical devices and diagnostic tools safer and more reliable. While these regulations may increase costs and timelines for manufacturers, they offer significant benefits:
- Improved patient trust in the devices they rely on.
- Reduced risk of errors or malfunctions.
- Compliance with EU standards to ensure smoother market access.
How to Stay Compliant
Manufacturers should:
- Start planning for clinical evidence requirements early.
- Engage with notified bodies to ensure alignment.
- Invest in software testing and cybersecurity measures.
- Get an Expert like Elexes by their side to ensure full compliance.
We understand keeping aligned with these regulations can be daunting for medical device manufacturing companies while simultaneously focusing on market growth. However, we can assure you that it can be a breeze simply by partnering with Elexes
