Insights & Intelligence for Regulatory Leaders

Today at Rimsys, we unveiled the 2023 MedTech Regulatory Performance Report, a new set of insights into the state of medtech regulatory affairs. Compiled based on interviews with 200 regulatory professionals and executives, the study provides a detailed look into how regulatory teams are staffed, their processes, the tools they use, and ultimately how they perform.

Why did we create this study? There were two driving factors behind the research. The first was a common theme that we heard from a number of our customers: Regulatory leaders don’t have clear data and benchmarks. They don’t necessarily know how long a new market submission should take, and how to plan for or assess the work of their teams. While other studies look at the medtech industry broadly or the state of the regulatory profession, this study tries to build a comprehensive resource for regulatory (and company) leaders.

The second factor was really for ourselves and the team at Rimsys. As a company building solutions specifically for medtech regulatory affairs, we wanted more insight into where companies were successful, where they struggled, and where we can add value.

What did we find? Regulatory teams perform a lot of hero work and rate themselves highly for their accomplishments. At the same time there is a lot of opportunity for process improvements, and companies that invest in digital transformation for regulatory affairs see better performance. ‍

Regulatory professionals are superheroes

Regulatory teams are generally pretty small. Most companies have less than 10 full-time regulatory professionals. These small teams complete an enormous amount of work. Last year on average, RA teams completed 50 license renewals, 50 license updates, and 10 new market submissions. This is impressive output.

Digging a bit under the covers, we found that this output relied heavily on the support of external consultants. 90% of companies use consultants to keep pace with their regulatory workload. Front-line employees also struggle with burnout. They were much more likely to report feeling under-resourced than regulatory leaders. ‍

But process problems persist

A lot of regulatory work remains extremely manual. 70% of regulatory teams spend half their time or more on repetitive administrative tasks.  All of this manual work increases the frequency of errors and required rework. 61% of companies reported a major non-compliance incident in the past 2 years.

Manual work also makes it difficult to complete regulatory projects in a timely fashion. Teams completed a lot of projects, but each took a long time. Over half of all companies spend 4 months or more on license renewals, license updates, and new market submissions.  ‍

Moving regulatory affairs forward

As regulatory requirements become more complex, there’s a natural question about how teams will work moving forward. MDR & IVDR in Europe have significantly increased the regulatory workload required to bring and keep products on the market. Will organizations be able to keep pace with the same resources, tools, and processes?  

No, and the performance report shows that medtech companies are investing to improve their regulatory capabilities. The majority of companies are planning to increase the sizes of their RA teams in 2023, and 40% expect to increase their investments in regulatory software. Companies are increasingly adopting specialized software to better support regulatory processes. ‍

Dig into the survey results

The full survey results provide insights into more aspects of regulatory performance. They show that companies need to take a deeper look into their processes and how regulatory resources are allocated. There are two ways to learn more:

1. Visit the survey page to see the full results (the survey whitepaper can be downloaded at no cost)
2. Watch the recording of our webinar with PA Consulting. We discuss the survey results in more detail and share our regulatory predictions for 2023

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Regulatory affairs professionals at large medical device companies must manage heavy submission workloads, registrations for products currently on the market, and ever-changing regulatory requirements. Many RA teams are still relying on paper documents, spreadsheets, and other outdated tools and methods to complete this work, while others have taken steps toward digitization and automation of key processes. 

Regulatory teams often struggle to find software tools designed specifically to help manage their regulatory projects. As a result, some RA teams attempt to repurpose software developed for other functions, such as electronic quality management systems (eQMS). While eQMS systems can provide some functionality that RA teams need, regulatory information management (RIM) software delivers a holistic platform designed to reduce administrative work and manage global compliance activities. In this post, we’ll compare eQMS and RIM software as they relate to regulatory compliance.

What is eQMS software? 

Electronic quality management systems (eQMS) are software programs that help quality teams centrally store, monitor, and manage quality and compliance processes. These platforms are usually provided via cloud technology as software-as-a-service (SaaS) solutions. They aim to provide digitization and automation of critical tasks that quality teams traditionally handle manually, such as quality, compliance, and design processes. For medical device companies, these requirements are defined by multiple standards, most notably ISO 13485:2016, FDA 21 CFR Part 820, and the EU MDR.

Digitization and automation are growing trends in most industries, including regulatory affairs and quality management. As you know, medical device manufacturers, especially their quality and RA teams, must manage a large volume of data, of which accuracy and consistency are of the utmost importance. eQMS systems typically handle data and processes in support of the following:

• Document management
• Non-conformance tracking
• Audit management
• Risk management
• Corrective and preventive action (CAPA) management
• Training management

This means that while eQMS software provides some functions and certainly have information that RA teams can use, they are designed around the processes that quality teams are responsible for. RIM software, on the other hand, is designed specifically to help regulatory specialists work more effectively and efficiently.

What are RIM systems, and what do they do?

Regulatory information management (RIM) systems have been around for years in the pharmaceutical industry, but are relatively new in the medical device industry. Comprehensive RIM systems enable users to create a single source of truth for all data associated with regulatory submissions and registration management. These systems lighten the burden on RA teams by digitizing data and automating key processes. 

RIM system functions are designed to support a range of regulatory activities across a product’s lifecycle. In addition to centralizing core regulatory data and managing regulatory registrations and certificates, RIM systems can also support:

• Submission planning, authoring, and assembly
• Market entrance requirements and pre-built submission templates
• Collaborative content authoring and project management
• UDI management
• Standards management
• Essential principles/GSPR management, including bulk updating

RIM systems also tend to be product-centric, structuring data around individual regulated products, as opposed to the process-centric approach taken by most eQMS systems. This means that RIM systems can track product-specific data, such as sales status by country, and link standards with individual products to easily identify products affected by standards updates and assess their impact.

Integrating eQMS and RIM systems

While processes in an eQMS system are designed to support quality and risk management requirements, they contain a lot of information that is relevant to regulatory affairs teams. RIM systems such as Rimsys are designed to integrate to eQMS, PLM, and ERP systems in order to coordinate processes and synchronize data. In the case of RIM and eQMS integrations, the systems can synchronize product master data to ensure smoother regulatory submissions and identify the impact of changing documentation on global product registrations and submissions. And Performance and testing data can be linked to digital essential principles tables.

RIM for regulatory projects and processes

Digitization and automation of regulatory data are more critical as global regulations continue to change and become more complex. Getting a medical device to market is a difficult process, but RIM software cuts the time and costs associated with product registrations while providing tools essential for ensuring ongoing compliance. Quality systems are critical as well, but their focus on risk management and corrective and preventative activities simply does not provide the functionality needed by regulatory teams. Integrate a strong eQMS system with a holistic RIM system to give both your quality and regulatory teams the tools they need to bring your products to market successfully and to maintain compliance. To get your regulatory ducks in a row, only a RIM system will do!

To learn more about the Rimsys RIM system, talk to one of our experts today.

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The latest announcement from the European Commission (EC) recommending an extension to the MDR transition period has led to sighs of relief throughout the healthcare community in the EU, where providers and patients have been concerned about the ongoing availability of life-saving medical devices. Medical device manufacturers, however, have no time to waste in moving forward with MDR certifications for their devices.

On January 6^th, the EC adopted the proposal recommended a month earlier to delay the full implementation of the Medical Device Regulation (MDR). The EU’s parliament and council now needs to issue final approval for the proposal, which will be processed through an “accelerated co-decision procedure.” While the proposed changes give medical device manufacturers some breathing room in recertifying existing devices, the changes do not apply to all devices or all situations and are not designed to allow manufacturers to delay the entire process of becoming compliant with MDR requirements.

Yes, if the proposal is approved by the European Commission as it is written today, your MDD-certified device may be able to remain in the EU market longer – the end of 2027 for high-risk devices and 2028 for medium- and low-risk devices. So, why do regulatory teams need to push forward as quickly as possible with MDR certification projects?

1. No extension for IVD devices

The proposed extensions to the transition periods apply only to medical devices covered under the MDR. The original deadlines for IVD devices as defined by the IVDR remain in place:

• May 26, 2025 - Class D IVD devices
• May 26, 2026 - Class C IVD devices
• May 26, 2027 - Class A sterile IVD devices and Class B IVD devices.

2. Lack of Notified Body resources

In April, 2022, a survey of MedTech Europe members revealed that MDR certificates had not yet been issued for more than 85% of the 500,000+ medical devices certified under MDD or AIMDD. Currently, certifications for lower classifications of devices take approximately 10 to 18 months; and for more complex products, the certification timeline can be two years or more. The number of Notified Bodies certified to review MDR applications remains low, and even if Notified Bodies are able to add resources in the coming years, review timelines will only become longer as companies rush to certify the hundreds of thousands of devices expected to remain on the market. The challenges will be even greater for smaller manufacturers and others that do not already have an established relationship with a Notified Body.

What does this mean for medical device manufacturers today? For those with higher-risk class devices, assume a 2-year certification period – which means starting the process with a Notified Body as early as possible, given the unknown availability of NB resources in the near future. At the latest, manufacturers need to have signed with a Notified Body by September 26, 2024 (Per Annex VII, Section 4.3 of the MDR). And prior to starting that process, of course, all required data, processes, and documentation should be in place. This means that any manufacturer who has not started this process needs to do so now.

3. Inability to update devices

The postponed MDR deadlines only apply to devices that do not present any unacceptable risk to health and safety and have not undergone significant changes in design or intended purpose. Any medical device certified under the MDD to which significant changes are made will need to recertify under the MDR before the updated device is placed on the market.

4. EUDAMED and UDI compliance deadlines remain the same

While the exact deadlines for EUDAMED compliance are based on the actual (future) release dates of all modules, The European Commission expects requirements around vigilance, clinical investigation and performance studies, and market surveillance modules to become mandatory by the end of 2024. The Commission is proposing a longer transition period for UDI/device registration and the notified body certificate modules, with a mandatory compliance date around the 2^nd quarter of 2026.  

Note that the expected EUDAMED compliance dates are prior to the extended MDR compliance deadlines. This means that information not previously tracked under MDD requirements will be mandatory within the next few years. This includes UDI and device information, including Basic UDI-DI (BUDI-DI). Post-market surveillance (PMS) and periodic safety update reports (PSUR), requirements of the vigilance and market surveillance module, also become required upon EDUAMED implementation.

5. MDR certification may affect registrations in non-EU countries

An increasing number of countries outside of the EU will accept CE certification as a path to accelerated market approval. In some countries, such as China, proof of certification in the device’s country of origin is required. It is unclear how these requirements will change in recognition of MDR requirements and deadlines. If your current regulatory strategy requires country of origin for the European Union, you may experience a more burdensome application process in other markets.

6. Opportunity to create a competitive advantage  

Instead of looking at MDR as an obstacle to overcome, medical devices manufacturers would be well advised to take this as an opportunity to create a competitive advantage. Companies without the necessary resources to re-certify all existing devices are expected to remove products from the EU market in the coming years. In addition, those companies who wait will likely experience higher costs and longer delays in obtaining certification – creating additional opportunities for their competitors.

And don’t forget that the transition period extensions apply only to legacy devices - any new products entering the EU market will require certification under MDR before being placed on the market!

If your data and processes aren’t yet fully ready for MDR, implementing a Regulatory Information Management (RIM) system as part of the process can create additional advantages beyond streamlining the MDR submission process. RIM systems digitize, automate, and simplify the submission and tracking of regulatory documents. The use of a RIM system not only speeds time to market, but provides regulatory teams tools for ensuring continued compliance for all products in all markets.

Doing nothing now is not an option

It is important to note that the extensions apply only to manufacturers that already have MDR compliance activities underway and have made an effort to become compliant, including the implementation of a compliant quality management system.  Per Annex VII, Section 4.3 of the MDR, manufacturers must submit a formal application for a conformity assessment by May 26, 2024. In addition, the manufacturer and Notified Body must have signed a written agreement no later than September 26, 2024.  The intent of the extended transition period is primarily to allow manufacturers to access Notified Body resources, and the Commission appears to be making an effort to limit any incentives for manufacturers to delay MDR certification.  

We expect to see leaders in the medical device industry embracing MDR compliance not only as a way to keep revenue-generating devices in market, but as a way to gain a competitive advantage and market share in the coming years.

Want to learn more? Watch a replay of our recent webinar  - Impact of the MDR transition period extension.

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The International Organization for Standardization (ISO) is the largest body in the world publishing standards. In fact, it is a conglomeration of standards bodies from over 160 countries working together to harmonize standards. As such, ISO 10993 is the international standard that is practically used globally for testing and determining the biocompatibility of medical devices. So it’s critical for medical device manufacturers to understand all 23 parts of ISO 10993 for the success of 510(k), pre-market authorization (PMA), and other device submission projects for regulatory authorities worldwide. As an example, the FDA has issued guidance on the Use of International Standard ISO 10993-1.

What is biocompatibility?

According to ISO 10993-1:2018, the current version of part 1 of the standard, biocompatibility is the ability of a medical device or material to perform with an appropriate host response in a specific application. Any device that comes into direct or indirect contact with the skin must be tested for biocompatibility. A medical device that makes indirect contact with the skin is one that encounters a liquid, gas, or another medium, that makes direct contact with the patient or user.

Categorizations for medical devices according to ISO 10993

When testing the biocompatibility of a device, it is broken down into two categories; one based on its type of contact with humans, and the other based on the duration of contact.

The categorizations for types of contact are:

• Non-contacting medical devices: These are medical devices that do not make direct or indirect contact with patients. Examples include in-vitro diagnostics devices, blood collection tubes, and petri dishes.
• Surface-contacting devices: Surface-contacting medical devices are ones that touch the skin, in-tact mucous membranes, and breached or compromised surfaces. Examples of these devices are catheters, contact lenses, and bronchoscopes.
• Externally communicating devices: Externally communicating devices are those that are partially or wholly external and come into contact with bodily fluids. These devices are usually intended to deliver or draw fluids to or from the body and are attached to an external delivery or withdrawal system. Examples include dialyzers and dialysis tubing accessories, transfer and transfusion sets, and arthroscopes.
• Implantable devices: Implantable devices are the riskiest type for medical devices because they are embedded within human tissue. Pacemakers, artificial larynxes, and heart valves are all implantable devices.

The categorizations for times of duration are:

• Limited exposure – Medical devices whose cumulative sum of single, multiple, or repeated duration of contact is up to 24 hours.
• Prolonged exposure – Medical devices whose cumulative sum of single, multiple, or repeated contact time is likely to exceed 24 hours but does not exceed 30 days.
• Long-term exposure – Medical devices whose cumulative sum of single, multiple, or repeated contact time exceeds 30 days.

Determining biocompatibility

Medical devices are most commonly made of metals, plastics, and fabrics, which are composed of chemicals with varying properties. Manufacturers must gather physical and chemical information about the device, which is vital to its biological and material evaluation and characterization.

For devices with components that are made of or utilize novel chemicals or materials, or those known to cause adverse effects, ISO 10993 requires rigorous risk assessment and management according to the standards of ISO 14971. Furthermore, there are prescribed data endpoints that set the foundation for determining the biocompatibility of medical devices and their intended uses and components.

The main things manufacturers must consider when determining the biocompatibility of medical devices and their components are listed below:

• Complete chemical characterization – ISO 10993 requires manufacturers to describe the chemical and material makeup of the medical device and its components, as well as the use of chemicals in the manufacturing of the device. Sometimes, a test of extractable and leachable chemicals is required to determine the safety of the medical device.
• Toxicological assessment – Toxicological assessment serves to determine and mitigate the risk of medical devices when they come into contact with patients and users. There are four pillars of toxicology assessment: hazard identification, hazard characterization, exposure assessment, and risk characterization.
• Biocompatibility testing – Biocompatibility testing is the process of testing the local and systemic effects of a medical device on the tissues it comes into contact with. Oftentimes a favorable toxicological assessment by a qualified individual, based on the facts of the thorough chemical characterization, can rule out the possibility of adverse effects and the need for biocompatibility testing.

ISO 10993 compliance

Biocompatibility assessment is a vital part of risk management according to ISO 14971. Ensuring compliance with risk management and biocompatibility assessment standards requires buy-in from all departments, from marketing and design to quality assurance and regulatory affairs.

It is vital that you begin considering ISO 10993-1:2018 in the early stages of product design. Part 1 of the standard will refer to additional parts, as listed in the following section. Completing your complete chemical characterization and toxicology assessment early in the process will help ensure the biocompatibility of your medical device during the design phase and expedite your device registration and time to market.

Also, it’s important to note that many regulatory authorities around the world have their own variation of ISO 10993. While these varying standards have the same foundation and are similar in many ways, you must understand their nuances if you plan to offer your medical device internationally.

ISO 10993 sections

ISO 10993 is made up of 23 different sections or parts, each of which is maintained and updated separately. Previews of the standard can be viewed on the ISO website, but full versions of the standard need to be purchased.

• ISO 10993-1:2018 – Evaluation and testing within a risk management system
• ISO 10993-2:2022 – Animal welfare requirements
• ISO 10993-3:2014 – Tests for genotoxicity, carcinogenicity, and reproductive toxicity
• ISO 10993-4:2017 – Selection of tests for interactions with blood
• ISO 10993-5:2009 – Tests for in vitro cytotoxicity
• ISO 10993-6:2016 – Tests for local effects after implantation
• ISO 10993-7:2008 – Ethylene oxide sterilization residuals
• ISO 10993-8: - Withdrawn (Selection of reference materials for biologic tests)
• ISO 10993-9:2019 – Framework for identification and quantification of potential degradation products
• ISO 10993-10:2021 – Tests for skin sensitization
• ISO 10993-11:2017 – Tests for systemic toxicity
• ISO 10993-12:2021 – Sample preparation and reference materials
• ISO 10993-13:2010 – Identification and quantification of degradation products from polymeric medical devices
• ISO 10993-14:2001 – Identification and quantification of degradation products from ceramics
• ISO 10993-15:2019 – Identification and quantification of degradation products from metals and alloys
• ISO 10993-16:2017 – Toxicokinetic study design for degradation products and leachables
• ISO 10993-17:2002 – Establishment of allowable limits for leachable substances
• ISO 10993-18:2020 – Chemical characterization of medical device materials within a risk management process
• ISO 10993-19:2020 – Physico-chemical, morphological, and topographical characterization of materials
• ISO 10993-20:2006 – Principles and methods for immunotoxicology testing of medical devices
• ISO 10993-22:2017 – Guidance on nanomaterials
• ISO 10993-23:2021 – Tests for irritation

How can we help?

Many manufacturers endure longer and more costly paths to market than necessary because they do not have systems and tools designed specifically for their regulatory teams. Furthermore, a lack of visibility and collaboration from departments that see regulatory teams traditionally as the “department of saying no” leaves ample room for human error in regulatory, quality management, and even marketing processes and activities. Read more about why we believe regulatory teams need to be considered revenue functions, not cost centers.

The resulting inefficiencies lead to problems such as marketing products with expired certificates, missing certificates, inaccurate and/or incomplete submissions, and even non-compliance with current regulatory requirements. Having a holistic RIM system is central to staying in compliance with standards, regulations, and guidance in the many markets around the world. Rimsys is the only RIM system of its kind built specifically for the medtech industry.

To learn how Rimsys can help your company get its regulatory ducks in a row, click here to schedule a demo.

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What is STED?

The STED, or Summary of Technical Documentation, format was created originally by the Global Harmonization Task Force (GHTF), the precursor to the current International Medical Device Regulators Forum (IMDRF). The original STED format, defined in 2007, was the first attempt to harmonize medical device submission information and standardize the information required under the EU MDD and regulations in other countries.  

As medical devices and corresponding regulations developed more stringent regulations that defined their market access submissions, regulators found that this original harmonized format did not require sufficiently detailed technical information, nor did it provide enough structure. As a result, more recent regulations have replaced STED with expanded requirements. Note that some in the industry may refer to “STED” when discussing the newer requirements that have replaced it.

Is STED still valid?

Technical documentation formatted using STED may come close to meeting current requirements in some cases. However, many major markets have updated their regulations and requirements for technical documentation, or they have standardized on MDR. EU notified bodies expect MDR technical files, which may have specific requirements depending on the notified body that a manufacturer is using.  

In addition to MDR in the EU, we have seen other countries over the past few years make changes to their regulatory systems and requirements, including:

• New regulations in China based on IMDRF in June, 2021 (Order #739)
• Emerging regulations in Canada and Brazil that are currently based on the IMDRF ToC
• New Regulations for Saudi Arabia that closely resemble EU MDR 
• Massive regulatory restructuring in ASEAN market

What has replaced STED?

STED has been replaced by the IMDRF Table of Contents (ToC) submission dossier. This submission template has more defined requirements than STED and we are seeing countries update their regulations to adhere closely to the IMDRF ToC. There are a few additional benefits to the IMDRF ToC:

• Additional Flexibility - The IMDRF ToC has a specific numbering structure for technical requirements that allow authorities to “pick and choose” requirements based on submission type and risk classification.
• Efficiency – Countries that use the IMDRF ToC will have a matrix structure for their submissions to note what is required (R), Conditionally Required (CR), Not Required (NR) or optional (O). This can cut down on extraneous information that does not need to be in a submission. Canada already has draft guidance in place with their matrix submission style.  
• Standardization – each country that follows the IMDRF ToC will number their submission document requirements with the same Table of Contents.

There are also other markets that are using alternative pathways to STED. The ASEAN market uses ASEAN CSDT (common submission dossier template), which is similar to the IMDRF ToC format, but uses different numbering. There are also two versions of the CSDT – one for standard medical devices and one for in vitro diagnostic devices.

Note that Singapore HSA has good information and is considered the “gold standard” for regulatory submission processes in the ASEAN market.

Expectations for future medical device submission requirements

We expect requirements to only get more complex and burdensome as countries move to further improve patient safety and address the needs of increasingly complex medical devices. A well-defined submission template strategy is critical to managing your device types. Within Rimsys, you can not only access standard IMDRF, NMPA, and other templates - you can design customized templates as needed for your holistic regulatory strategy.  

Additional resources

• IMDRF ToC IV
• IMDRF ToC n-IVD
• Health Canada ToC Matrixes
• NMPA Submission Matrixes (in Chinese)

Would you like to learn more about how Rimsys handles submission templates? Schedule a conversation with our experts now.

There’s no question that the medical device market is global, and the United Kingdom (England, Scotland, Wales, and Northern Ireland) is one of the world’s most viable and vital markets. It’s certainly one that you want your medical device in if you hope to make a global impact. The Medicines and Healthcare products Regulatory Agency (MHRA) is the gatekeeper of that market and one of the world’s most influential regulatory bodies.

Knowing who the MHRA is and understanding their role in ensuring that only safe, effective, high-quality medical devices enter the market is vital to your success in the UK. In this brief article, we’ll tell you more about who the MHRA is, their authority and responsibilities, and even some of the requirements you must meet to get your medical device into this market.

What is the MHRA?

The MHRA is an executive branch of the Department of Health and Social Care. It’s the UK’s equivalent of the US Food and Drug Administration (FDA), meaning that they set the quality and regulatory standards for medical devices in Great Britain.  

Because the UK used to be part of the European Union, products required a CE marking to enter the UK market. Since Brexit, the MHRA has been the sole regulatory authority in Great Britain (England, Scotland, and Wales) and the gatekeeper to its robust medtech market.

What does the MHRA do?

As you know, medical devices must meet specific requirements before they can be sold in most markets around the world. Generally, the more developed the nation and its healthcare and medical device industries, the more complex its healthcare regulations are.  

The MHRA is responsible for:

• Monitoring and regulating post-market surveillance of all medical devices currently on the market and creating regulations and requirements for medical devices entering the UK. They also enforce regulations, ensure medical devices meet the necessary safety, efficacy, and quality standards, and have the power to pull noncompliant products from the shelves.  

• Making sure that supply chains for medical devices and the materials that comprise them are safe and secure. This includes everything from the facilities where products are made and stored, to their packaging and the systems and logistics applied in their transport.  
• Educating the general public, healthcare professionals, and manufacturers about the risks and health benefits of medical devices.  
• Engaging in harmonization efforts with other countries to develop standardized pathways to global markets. They influence international regulatory standards, best practices, and frameworks to support this effort.  

How do you register a medical device with the MHRA?

Registering a medical device in the UK is different than in years past due to Brexit, which was the British exit from the European Union. Before Brexit, the UK adhered to the EU regulatory requirements as put forth in the EU MDD/IVDD, which Regulation EU 2017/745 (MDR) and Regulation EU 2017/746 (IVDR) eventually replaced. However, the MHRA will be instituting its new regulations currently set to be in force in July 2024.

One of the first steps of registering a product in the UK is getting the UK Conformity Assessment (UKCA) marking on your device and packaging. Manufacturers of Class I (lowest-risk classification) devices and general In Vitro diagnostic devices can self-certify against UKCA marking if these devices are non-measuring and non-sterile.  

Class II and III devices must go through conformity assessment by a UK approved body. Approved bodies are the UK’s equivalent of Notified Bodies in the EU. These organizations have the authority to perform conformity assessments and apply UKCA markings on medical devices. UK approved bodies also perform post-market surveillance of devices currently on the market to ensure they’re safe and compliant for as long as they’re in use.  

The process is a little different for device manufacturers outside of the UK who want to market their medical devices. Foreign manufacturers must designate a single person based in the UK to serve as their authorized representative (or UK Responsible Person). The UK Responsible Person acts as a liaison between the manufacturer and the relevant approved regulatory bodies, and handles the task of registering that company’s products with the MHRA.  

The MHRA and Northern Ireland

When registering a device in Great Britain and Northern Ireland, you’ll notice that there are different procedures even though both were part of Brexit. According to the Northern Ireland Protocol (Northern Ireland’s response to Brexit), Northern Ireland applies Regulation EU 2017/745 (MDR) and Regulation EU 2017/746 (IVDR) to its own regulatory framework, whereas Great Britain has decided to implement its own regulations over the next couple of years.

For instance, as Northern Ireland still adheres closely to  Regulation EU 2017/745 (MDR) and Regulation EU 2017/746 (IVDR), UK approved bodies cannot provide conformity assessments for them. In fact, if a manufacturer based in Great Britain wants to put a medical device on the market in Northern Ireland, they must designate an EU Authorized Representative to register the product for them.  

Furthermore, an EU Notified Body must provide a conformity assessment according to Regulation EU 2017/745 (MDR) and Regulation EU 2017/746 (IVDR) for the device to receive UKNI marking (Northern Ireland’s conformity assessment mark). Likewise, Northern Ireland Authorized Representatives cannot represent Northern Irish or other foreign manufacturers in Great Britain, nor can Northern Ireland Notified Bodies provide UKCA marking for medical devices. In short, Northern Ireland has decided to continue to abide by EU medical device and in vitro diagnostics regulations as set forth by the European Medicines Agency, whereas Great Britain has not.  

How to achieve compliance

The MHRA is firmly positioned as one of the foremost regulatory authorities in the world. They’re responsible for creating, implementing, and enforcing regulations for medical devices and IVDs in the UK while also providing research and education to promote the safety and efficacy of devices worldwide.  

Adherence to UK regulations is essential to getting your medical device on that market and keeping it there. Medical devices entering the Great Britain market must adhere to the MDR/IVDR (until June 30, 2023) or UK MDR 2002, whereas Northern Ireland still abides by EU regulations.  

Manufacturers based outside of Great Britain that want to put their devices on the market there must designate a UK Responsible Person (UKRP) to represent their interests and a UK-approved body to perform conformity assessments and apply UKCA marks. At the same time, Northern Ireland still adheres to EU regulations, requiring foreign manufacturers to utilize EU and NI responsible persons and notified bodies to assess medical devices, documentation, and manufacturing facilities while requiring the EU’s CE marking.

Bringing your device to market in the UK requires a dynamic regulatory strategy that enables you to optimize your projects and processes, ensuring your medical devices hit the mark for both the GB and NI markets. Also, it’s vital that you do your due diligence to ensure conformity with the regulations of both markets while also avoiding conflating their processes and regulatory requirements. Ultimately, getting your medical devices compliant with both markets could set your medtech company up to be a mainstay in the UK.  

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