Insights & Intelligence for Regulatory Leaders

“Regulatory has a seat at the table.” This quote, while seeming innocuous, is actually quite meaningful. The context is a discussion about regulatory digital transformation. At RegUP Boston, one of our customers was discussing the organizational conditions that led to a large-scale digital transformation initiative across regulatory affairs for an enterprise medical device manufacturer. The change was precipitated by a clear awareness of the impact that regulatory affairs has on both the top and bottom lines of the business. As a result, the regulatory team was given a voice in business strategy, and an opportunity to invest in growth.  

The challenges of ‘cost-center’ thinking

At some level, this would seem obvious. Of course regulatory affairs is strategic in a highly-regulated industry. Yet despite this, most RA teams are treated primarily as a cost center—a function that doesn’t directly contribute to revenue or profit. This means that the business is continually looking to minimize the cost incurred by regulatory activities, but more importantly, it leads to significant friction between teams. Rather than a go-to-market partner, regulatory is viewed as an operational impediment to revenue generation by sales and marketing teams.  

Cost-center thinking also manifests itself in poor measurement and objectives for regulatory teams. Often regulatory teams are assessed by volume-based metrics: number of submissions completed, speed of submission completion, and percentage completed ‘on-time’. While these are decent measures of output, they don’t have a direct correlation with revenue. Submissions or renewals that can be completed quickly aren’t necessarily associated with the highest-value products or markets.

Staffing levels also aren’t well optimized in a cost-center mindset. Apart from attempting to minimize full-time regulatory staff, many companies allocate regulatory headcount based on device risk classes or number of markets served. Again, these are good benchmarks for ongoing work volume, but they don’t necessarily align with future go-to-market plans or revenue targets for different product lines. This approach can leave RA teams under-resourced, and force businesses to rely on consultants when regulatory staffing levels “unexpectedly” don’t match got-to-market needs.

Regulatory is a key contributor to revenue and profit

Treating regulatory affairs as a cost center misses an important reality: regulatory clearance is an essential aspect of revenue generation in the medtech industry. It’s a prerequisite for growth, as any new product or geographic expansion of an existing product requires a new market submission and approval from health authorities before it can be sold. Regulatory affairs also has direct responsibility for sustaining revenue. The regulatory lifecycle of a product doesn’t end after market clearance. RA teams ensure the continued revenue stream from a product by keeping track of license expirations, relevant regulatory and standards changes, and managing post-market surveillance activities.

Unlike (necessary and valuable) support functions like accounting or IT, there’s a direct line between regulatory activities and revenue for the business. This means that RA functions are obviously important, but also that alignment between sales, marketing, and regulatory affairs is necessary for go-to-market success.

An analogy: sales & marketing alignment

There is a similar dynamic at almost any B2B business between sales and marketing teams. Nobody would question that both sales and marketing have responsibility for revenue generation, but that doesn’t always mean they are closely aligned. If teams don’t have an agreed-upon revenue target (X% of sales should be driven by marketing activities), marketing teams can end up measuring themselves on things that have less direct business impact such as website traffic or re-shares of social media posts. This leads to conflict between teams as different activities are prioritized, and sales teams perceive that marketing isn’t an active, helpful partner.

It’s not that marketing teams aren’t executing in the outlined scenario, it’s that the measures and priorities aren’t aligned. When sales and marketing share a defined revenue goal, upstream measurements like new lead and pipeline generation guide marketing activity prioritization. Marketing reports on results that are relevant to sales goals, and sales teams have clarity into how marketing is contributing. The result is an aligned and productive, rather than adversarial, go-to-market motion.  

What does revenue-aligned regulatory affairs look like?

Note that this is not an accounting discussion. Alignment here is not about how medtech companies should account for expenses associated with regulatory compliance. Rather it’s about how regulatory objectives and investments should be structured. Changing those structures to be revenue aligned produces two beneficial outcomes.

The first is in regulatory planning. When marketing activities are derived from revenue goals (like pipeline generation) the result is that activities that have the highest revenue impact are prioritized. If regulatory affairs teams carry a revenue target, the projects that are prioritized are those with the highest revenue impact. This simple criterion drives closer alignment between regulatory, marketing, and sales teams, and prevents priorities from being determined by the “loudest” voices in the room, or project length/complexity—which can happen when RA teams are measured on activity alone.

The second outcome is a shift in investment strategy. In a cost-center mindset, all investments are designed to minimize costs. In a revenue mindset, investments are driven based on expected returns. When regulatory projects are prioritized according to revenue impact, it’s easier to allocate headcount based on the anticipated workload as a return on each additional hire can be easily estimated. The same goes for investments in technology and tools. With a direct line between work product and revenue, it’s easier to make the business case for investment. In the same way that marketing campaigns require investment to generate sales opportunities, regulatory projects require investment to create revenue for the business.

Revenue alignment improves organization and focus for regulatory affairs teams. It allows them to effectively prioritize activities, and plan to adequately staff them. It reduces a focus on activity for activity’s sake and instead strengthens alignment across all go-to-market teams. It also makes it easier to justify investments in improving regulatory processes. From new tools to end-to-end digital transformation, regulatory affairs can be optimized to deliver on revenue projections.

Why give regulatory a “seat at the table”?

Medical device and in vitro diagnostic companies simply won’t have a choice. The current approach to managing regulatory affairs isn’t keeping up with the pace of change in the industry. The MDR and IVR rollout in the EU is expected to leave 50% to 76% of the products currently on the market behind. RA teams that are measured on work volume (as much as possible), at the lowest possible cost aren’t effective in this environment, and the organizational friction between them and other go-to-market teams will only further hinder execution.

Companies that succeed in today’s environment are those that take a different approach to regulatory affairs. By treating regulatory as a revenue function and aligning regulatory activities to financial goals, companies can more strategically plan for regulatory workload. They can prioritize projects that have the largest impact on the business while reducing churn and repetitive administrative work within the team. They can justify investments in productivity and process improvement by tying them to expected return for the business. And they create tight alignment across marketing, sales, and regulatory affairs in an integrated go-to-market motion for the business.

Your submission questions answered for imported devices in China

Our latest “Ask us Anything” webinar this week focused on the topic of medical device submission strategies for China, specifically for devices being imported into China. Karen Cohn, Regulatory Specialist here at Rimsys was on-hand to answer everyone’s questions. Karen specializes in international submission strategies and was a subject-matter expert on NMPA submissions while at Philips.

In this article, we have included the most common questions we received and put them together with their answers, along with related links to additional information that was mentioned during the webinar.

‍Remember that you can always ask us a question by using #AskRimsys on Twitter or LinkedIn - or using our short survey. Your questions help us select topics for upcoming webinars, and every week we select one question to answer directly on our social media channels.

The following list provides direct links to relevant CMDE information (Center for Medical Device Evaluation of the NMPA). These sites are in Chinese, but we have found that Google translate does a good job of providing English versions for purposes of researching regulations, but be sure to obtain verified translations for documents and regulations that are important to your organization.

• CMDE Main Page
• CMDE QMS Guidance 
• Class I CMDE Guidance (requirements and instructions are in the documents at the bottom of the page)
• Clinical Evaluation Guidance (following the guidance depends on which Sub-Category your device falls under)
• Guiding Principles 
• Innovative Device Pathway

Karen’s answers are below.

Q: Do I need to have submission documentation translated into Cantonese or Mandarin?

Cantonese and Mandarin are spoken dialects of Chinese. What you are looking for is a Simplified Chinese Translation, which is the written language. There is also a written language called Traditional Chinese, but the NMPA only accepts translations into Simplified Chinese. You will also need to provide the original document as well. 

Q. How do I find the NMPA standards that may be applicable to my device?

The CMDE (Center for Medical Device Evaluation) has information on its standards and guiding principles (see additional links at the top of this article). 

Standards for China have differences from their ISO and other standard association counterparts. There may be different labeling, testing, and other requirements. I would highly suggest that you get verified translations of these standards and review them during the developmental period of your device. 

Q. Could you elaborate on essential principles and using the EU GSPRs instead?

You can try to use EU GSPRs, but it is important that you do a gap analysis first and note that the EU GSPR will be using ISO and Harmonized Standards, whereas the NMPA essential principles will need to use NMPA standards. Note that the NMPA is very particular about the organization of their submission information, which includes essential principles.

Q. Is there a pathway for combination products, or is China similar to the EU in that the drug and the device need to be approved separately?

The short answer is that there is a combination pathway, which is closest to the pathway available with the FDA. You are required to submit to the CMDE and the CD (Center for Drugs) and they coordinate with each other and with you. I would highly recommend having a pre-submission meeting to determine which agency should be leading the process.

Q. How do I let leadership know of the personnel cost of registering in China?

It is important to align with your manager and director if you are a specialist, especially if they are not currently aware of the process of registering a device in China. 

Q. How do I effectively work with my China counterparts to coordinate my submission activities? 

I’ve been in situations where you are working with a China counterpart - sending them detailed information and documents mainly by email and SharePoint - but you don’t get the final documentation back to review and don’t see the final submission product. The actual submission can become a bit of a black hole, which is a compliance risk. Using a tool like Rimsys can help, because it allows you to create separate submission templates such as the NMPA PTR and the NMPA eRPS ToC. You can then use these templates to easily create the submission documents. You also can clearly assign owners and track progress for each section of the submission to clearly indicate who should be doing the work.

Q: Could you elaborate on QMS requirements?

QMS requirements have recently been updated, and the NMPA is now requiring QMS information in submission documentation. For a while, there was no guidance regarding QMS requirements, but guidance has recently been released for the inspection criteria.

Q: Could you elaborate on clinical evaluation requirements?

Clinical evaluation requirements depend on the device type. There are a number of pathways listed on the CMDE website and your clinical team will need to understand which one is applicable to your device(s). 

Q: For large devices, such as MRIs, are there any unique steps or additional information we need to provide? 

Building and installing a device can take 18+ months and special site requirements need to be met before clinical trials can start.

You can certainly include this information in your submission. Strongly consider sending someone from your organization with the device when it is time for type testing. It is up to the manufacturer to make sure that the type testing is done correctly, to your standard, and under conditions that are compliant with your requirements.

Q: Does NMPA have an abbreviated pathway if the device has been 510(k) cleared or EU CE marked?

China requires that the device be approved/cleared in its country of origin. This doesn’t provide an abbreviated pathway.  

Q: What is a PTR?

PTR stands for Product Technical Requirements. It is a document that outlines the device specifications and testing methods based on the applicable Chinese standards. This is an important document used for the in-country testing required for registration in China and for the NMPA submission. Once approved, the NMPA testing center will stamp the PTR and send a testing summary. Both items are needed for the market access submission for Class II and III regulated products. Class I devices also need a PTR even though they do not go through type testing. 

Q: Do medical device registrations expire?

Class II and Class III Registrations expire after 5 years from their certificate approval date.  The renewal must be submitted six months prior to the expiration date. 

If the mandatory standards for medical devices have been revised, you may need to submit a change notification. Note that a change notification and a renewal cannot be submitted in parallel, so be conscious of the requirements and leave yourself enough time to get through the submission process.

Q: Are pre-submission consultations available? 

Yes, pre-submission consultations are available through the NMPA. Ensure that you document all meetings and discussions, as it is required to include meeting notes in market-entry submissions for class II and class III devices.

You may also be interested in our Ultimate guide to the China UDI system and database.

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The FDA maintains many publicly accessible databases that are valuable to medical device manufacturers preparing product submissions, compiling post-market data, researching guidance documents, and more. We have listed some of the most commonly used databases below, along with a summary of information they provide and how they can be used.

FDA databases useful for new medical devices

Product Classification

This database contains medical device names along with the three-letter device product code and device classification. Manufacturers may use this database to properly classify a new device. 

• ‍Search the CDRH product classification database
• Read A primer of medical device classification (includes device classification information for multiple countries)

Pre-market Notifications - 510(k)

The 510(k) database includes all released 510(k) submissions and can be searched by 510(k) number, type, product code, device name, and more. In order to use the 510(k) pre-market notification process, a new device requires that an existing predicate device that also used the 510(k) process be identified. Use this database to identify devices that are substantially equivalent to the new device and meet the requirements of a predicate device. 

• ‍Search the 510(k) pre-market notification database
• ‍Read The beginner’s guide to the 510(k)

Pre-market Approvals (PMA) 

The PMA database lists pre-market approvals, including supplements that have been approved. PMA data can be searched by PMA number, device name, decision date, supplement type, and more. A new device that is substantially equivalent to a PMA-approved device means that the new device will require a PMA and be classified as a Class III device. 

• ‍Search the Pre-market Approval (PMA) database
• Read The beginner’s guide to the FDA PMA submission process

De Novo

The De Novo database includes all De Novo classification orders and can be searched by De Novo number, product code, 510(k) number, device name, and more. The De Novo process allows medical device manufacturers to request reclassification for novel devices with low to moderate risk profiles, that would otherwise be automatically classified as Class III devices.

• ‍Search the De Novo database
• ‍Read The beginner’s guide to the FDA De Novo classification process

Devices@FDA

The Devices@FDA database provides a simple search of both the 510(k) database and the PMA database. While convenient for initial searches, it only allows searches by device name and approval date.

• ‍Search the Devices@FDA database

Standards and guidance documents

CFR Title 21

The FDA provides a searchable online reference database for Title 21 that provides an organized table of contents and timelines of changes to the regulation.

• ‍View the eCFR system

FDA guidance documents

FDA guidance documents provide the FDA’s interpretation of regulatory policies, discuss the application of regulations to specific products, and also provide guidance for industry. Guidance documents can be searched for based on product, topic, issue date, FDA organization, and more. In addition, users may browse a list of guidance documents by topic.

• ‍Search for FDA guidance documents

FDA recognized consensus standards

The FDA provides a searchable database of voluntary consensus standards to which the agency will accept a declaration of conformity. Because these are standards developed by different organizations, this database can be searched by standards and organization, along with keywords, product codes, and more. 

• ‍Search the database of recognized consensus standards

Unique Device Identifier - UDI

GUDID 

AccessGUDID provides searchable access to the GUDID database of device information, including the device identifier, device name, company name, and more. 

• ‍Learn more about GUDID and searching the GUDID database
• If you are looking for information on submitting UDI information to the GUDID database, see the FDA’s GUDID submission page.

FDA post-market databases

522 Post-market surveillance studies program

This database allows users to search post-market surveillance studies by manufacturer or device. The 522 post-market surveillance studies program defines requirements for the design, tracking, oversight, and review of studies mandated under section 522 of the FD&C act.

• ‍Search the 522 post-market surveillance studies database

MedSun reports

The Medical Product Safety Network (MedSun) is an adverse event reporting program launched in 2002 designed to allow the CDRH to work collaboratively with the clinical community to identify, understand, and solve problems related to the use of medical devices.

• ‍Search the MedSun database

Post-approval studies (PAS) 

The post-approval studies (PAS) database contains information about studies that manufacturers are required to complete as a condition of device approval. The PAS database can be searched by applicant or device information.

• ‍Search the PAS database

Medical device recalls

The medical device recall database contains recall information since November 1, 2002, and can be searched by product, recall class, product code, recall date, root cause, and more. 

• ‍Search the medical device recall database
• ‍Recall information for biologics regulated by the CBER 

MedWatch

MedWatch is the FDA safety information and adverse event reporting system that is available to health professionals, patients, and consumers. Note that in addition to medical devices, MedWatch is available for reporting on medicines, biologics, cosmetics, and food.

• ‍MedWatch reporting and database search

Additional FDA databases

Establishment registration and device listing

The registration and listing database contains information on all establishments engaged in the manufacture, preparation, propagation, compounding, assembly, or processing of medical devices. It also includes listings of medical devices in commercial distribution by both domestic and foreign manufacturers. Establishment owners are generally required to register their facilities and devices with the FDA annually.

• ‍Search the registration and device listing database

Total product lifecycle (TPLC)

The TPLC database includes both pre-market and post-market data about medical devices, including PMA and 510(k) approvals, adverse events, and recalls. The TPLC database can be searched by device name or product code and includes full reports by product line.

• ‍Search the TPLC database

Do your research!

In many cases, the same information is contained in multiple databases, so take the time to understand which databases provide the right combination of data for your needs. This article references only a portion of the FDA database. See the FDA’s Medical Device Databases listing for all of the available FDA databases.

The medical device industry is vast and diverse, with each country or regional authority having its own regulatory body and requirements. For instance, medical devices are classified in ascending order in the United States, with Class I devices being the lowest risk class. Devices that pose the highest risk to users or patients and require the most regulatory oversight (pacemakers, defibrillators, etc.) are Class III devices, and devices that pose a moderate risk, such as syringes and catheters, are Class II devices. While this is a logical way to categorize medical devices, not every country uses this model. 

Medical device regulations will likely never be universally uniform. Still, there is a concerted effort on behalf of regulatory experts from some of the largest medical device markets in the world to harmonize regulations and regulatory best practices. The International Medical Device Regulatory Forum (IMDRF) is a body of medical device regulatory specialists from around the world working together to standardize regulations and “accelerate international medical device regulatory harmonization and convergence.” While the IMDRF isn’t a regulatory body, its guidelines are often adopted by its member countries and adapted to fit their regulations and initiatives. In this article, we’ll give you an overview of the IMDRF, including its history and how its work impacts the global medical device industry.

The IMDRF’s beginning

The IMDRF was conceived in 2011 when Australia, Brazil, Canada, China, the EU, Japan, the US, and the World Health Organization (WHO) met to discuss the formation of this forum. One of their main goals was to build on and expedite the work of the Global Harmonization Task Force (GHTF), the organization that laid the foundation for the IMDRF. 

The idea for the GHTF came from a meeting between representatives from the US, EU, Canada, and Japan in 1992. They met to discuss the possibility of forming a “consultative body” of regulatory specialists with the goal of “harmonizing medical device regulatory practices” worldwide. The GHTF held its first meeting in January 1993, forming study groups to evaluate different aspects of regulatory processes, including each member nation's quality management and Good Manufacturing Practices (GMPs). Today, the IMDRF continues to build on the strong foundation laid by the GHTF.

IMDRF members

As mentioned, the IMDRF works to harmonize medical device regulatory best practices worldwide. This mission requires the cooperation of regulators from many countries, performing in-depth studies and publishing guidelines that shape the global regulatory landscape. There are 11 members and their regulatory authorities that comprise the IMDRF:

• Australia - Therapeutic Goods Administration (TGA)
• Brazil - Brazilian Health Regulatory Agency (ANVISA)
• Canada - Health Canada
• China - National Medical Products Administration (NMPA)
• The European Union - European Commission (EC)
• Japan - Pharmaceutical and Medical Device Agency (PMDA)
• Russia - Russian Ministry of Health
• Singapore - Health Sciences Authority (HSA)
• South Korea - Ministry of Food and Drug Safety (MFDS)
• The United Kingdom - Medicines and Healthcare products Regulatory Agency (MHRA)
• The United States of America - US Food and Drug Administration (FDA)

IMDRF functions

The IMDRF is an international medical device regulatory body that offers guidance rather than implementing binding regulations, i.e., they don’t have the authority to mandate directives. According to the FDA, they “develop internationally agreed upon documents related to a wide variety of topics affecting medical devices.” Its members develop these documents by conducting studies via working groups, which we discuss in the next section.

IMDRF working groups

The IMDRF working groups are like subcommittees that focus on specific regulatory issues pertaining to medical devices. They address new technology, trends, and areas where harmonization of standards and regulations would be most beneficial. Their working groups conduct studies and research with the aim of providing regulatory best practices and universally applicable guidelines. There are currently seven active working groups:

• Adverse Event Terminology 
• Artificial Intelligence Medical Devices  
• Good Regulatory Review Practices  
• Medical Device Cybersecurity Guide  
• Personalized Medical Devices (PMD)  
• Regulated Product Submission  
• Software as a Medical Device (SaMD)

There are various participants in every active working group, and these groups can also include regulatory bodies that aren’t IMDRF members. Through their sharing and collection of data, working groups gain valuable insights that enable them to create guidelines that IMDRF members can relatively and easily implement around their existing medical device regulations. This helps to ensure the safety and efficacy of medical devices while promoting the harmonization of regulatory best practices and standards. These documents serve to accelerate the convergence of medical device regulations around the globe and have produced 69 guidances to date.

The IMDRF might not be a regulatory body or have any binding authority, but they are well respected within the medical device community. Their guidance documents help to shape regulatory standards in the world’s largest medical device markets.  Staying abreast of IMDRF developments is a regulatory intelligence best practice (much like having a holistic regulatory information management system that provides structure for the medical device industry). Shameless plug aside, understanding the current undertakings of IMDRF working groups is a great way to better understand what’s going on in the medical device regulatory world and what changes might be coming down the road.

To learn more about the IMDRF, visit their website at imdrf.org.

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At Rimsys, we pride ourselves on delivering tools that empower medical device regulatory affairs professionals to simplify and automate daily workflows, react quickly to changing regulations, and track product registrations around the globe. In order to deliver software that empowers RA teams to exceed regulatory campaign expectations, we not only need to understand current and changing global regulations; but we also work hard to understand what the community is talking about, what issues they are trying to solve, and what they would like to explore in more depth. 

So - we are asking for your input!

In order to address the topics that are of most interest to you, we’re launching our “Ask Rimsys” campaign. As part of this initiative, we invite you to submit your medical device regulatory questions to us - and once a week we’ll choose a question to answer either via direct social media response, a blog post, or even a short video response. Preference will be given to the following:

• Questions with interest to the broader regulatory community (we will not be able to provide individual or company-specific consultation).
• Questions which touch on regulatory workflows and best practices.
• Questions dealing with the use of technology in optimizing regulatory activities.

If your question is selected, we’ll send you some Rimsys gifts - typically one of our highly requested “Regulatory Ducks in a Row” t-shirts featuring our too-cool for regulatory problems mascot, Reggie the Regulatory Duck. Look for random giveaways during the week too!

We’ll also be holding periodic “As us Anything” webinars with our regulatory team and other experts. These webinars will most often cover a broad topic, such as UDI, and we will take questions ahead of, and during, the webinars. Check out our events page for a list of upcoming webinars and recordings of past webinars.

As a company built by regulatory professionals, we understand the constant pressure on regulatory affairs professionals to stay on top of the changing regulatory landscape and improve your game. That’s why we’re committed to being a reliable friend and a source of relevant information - as well as a provider of world-class RIM software and services. So, help us focus on the issues most important to you by submitting your regulatory questions on Twitter by using #AskRimsys (and be sure to follow us) or answering our short 3-question survey.

And feel free to respond to any of questions or our responses with any regulatory insights you have as well. We look forward to hearing from you, and remember, #AskRimsys!

The medical device industry is vast, diverse, and heavily regulated, with different countries and regions having varying regulatory requirements and processes. The European Union (EU) is one of the largest markets in the world for medical devices, and if you intend to put a medical device on the market in the EU, there is a good chance you’ll have to work with a Notified Body. 

So, what is a Notified Body? In this brief blog post, we’ll discuss what Notified Bodies are, what they do, and how to work with one. 

What is a Notified Body?

Notified Bodies play the role of gatekeepers to the EU market for a majority of medical devices/in vitro diagnostics. Notified Bodies for medical devices are independent organizations appointed by EU member states to assess the conformity of certain products before they are placed on the market. Conformity assessments ensure that products are technically safe, compliant, correctly documented, and manufactured under the correct conditions as outlined by applicable legislation, primarily the EU MDR and IVDR in the case of medical devices. 

It’s important to note that not all Notified Bodies have the capability to perform assessments for all types of products. For instance, some Notified Bodies have been designated for MDR, meaning they can perform conformity assessments according to EU MDR 2017/745, Article 35, and others can provide conformity assessments for in vitro diagnostics (IVDs) in accordance with EU IVDR 2017/746, Article 32. It’s essential to make sure you work with the right Notified Body to get your medical device to the EU marketplace. 

What types of medical devices require a Notified Body?

Medical devices regulated under the MDR as Class IIa, Class IIb, or Class III devices require that a conformity assessment be performed by an accredited Notified Body before receiving a CE marking and being placed in the market. Some Class I devices also require an assessment by a Notified Body, including devices that are sterilized, have a measuring function, or are reusable surgical instruments. Other Class I devices can be self-assessed by the manufacturer. 

In vitro diagnostic (IVD) devices designated as Class B, Class C, or Class D also require a conformity assessment by a Notified Body. Only Class A IVDs can be self-assessed by the manufacturer.

What is the role of Notified Bodies under the EU MDR/IVDR?

All medical devices must have CE marking before they can enter the European market. One of the main roles of Notified Bodies is to provide conformity assessment on medical devices before granting them a CE marking, which is also known as a “European Passport,” as it allows products to move relatively freely throughout the EU. 

Notified Bodies provide conformity assessment during both the design and production phases of a product, ensuring that medical device manufacturers live up to the requirements of the MDR/IVDR. They audit manufacturing processes and conditions, quality management systems (QMS), and product specifications to make sure that they conform with EU regulations before being placed on the market. It’s also the role of the Notified Body to make sure the manufacturer has the infrastructure in place to market and provide post-market surveillance in the EU.

Notified Bodies provide conformity assessment in support of the EU MDR/IVDR General Safety and Performance Requirements (GSPR) but ultimately, it’s the manufacturer’s responsibility to ensure all requirements have been fulfilled. This includes choosing the right Notified Body to work with to get their medical device on the EU market. 

How do you choose the right Notified Body to work with?

It might surprise you to know that not all Notified Bodies are designated for both MDR and IVDR, meaning that it is critical that you do your due diligence to connect with the right Notified Body for your product. Notified Bodies are designated by the competent authority of EU member states to perform certain types of conformity assessments for certain types of medical devices and manufacturing processes/conditions. This means that the Notified Body you work with is largely dependent on the type and classification of your medical device as well as the type of conformity assessment process you want the Notified Body to perform. A list of accredited Notified Bodies is available in the EU NANDO database, which can be searched and filtered by country, specific legislation, and other technical competencies.

A lot rides on selecting the right Notified Body, so it’s imperative that you find the organization that best fits your company’s needs. Learn what you can about their processes, how they communicate with their clients, and even their submission templates and processes. Choose an organization whose standards and processes align with your company’s goals. 

According to Rimsys regulatory expert, Bruce McKean, when it comes to working with a Notified Body, “You can benefit from building a relationship with your Notified Body and collaborating with them on various topics. Although MDR and IVDR have forced more stringent requirements that may hinder a consulting relationship, they’re usually willing to offer a certain level of guidance to help you.”

Choosing and working with an Notified Body is a critical step towards getting your product on the EU market, especially for new medical devices. Be sure to do your research before selecting an Notified Body, and communicate with them throughout the product realization phases to ensure your medical device is in compliance with MDR/IVDR requirements. Working successfully with a Notified Body is the best way to fast-track your medical device into one of the largest markets in the world. 

Read more about the general safety and performance requirements (GSPR) that Notified Bodies use as the basis for conformity assessments.

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