Choosing the Right Notified Body for CE Marking: A Manufacturer’s Guide

12 Mar

CE marking is a crucial regulatory requirement for medical devices in Europe, signifying compliance with the European Union Medical Device Regulation (EU MDR 2017/745). This certification ensures that a product meets essential safety and performance requirements before being marketed in the European Economic Area.

One of the most critical steps in obtaining CE marking is selecting the right Notified Body (NB). Not all NBs are designated for all device types, and choosing an unsuitable one can lead to costly delays or non-compliance. This guide will help manufacturers navigate the selection process, outlining key factors to consider and providing a list of designated EU MDR-compliant NBs.

Understanding Notified Bodies: Their Role in CE Marking and EU MDR Compliance

When seeking CE marking for a medical device under the EU Medical Device Regulation (MDR 2017/745), selecting the right Notified Body (NB) is one of the most crucial decisions a manufacturer will make. A Notified Body is an independent third-party organisation designated by an EU member state to assess medical devices for regulatory compliance. The role of a Notified Body extends far beyond simply approving a product - it involves ongoing oversight, ensuring that medical devices remain compliant throughout their lifecycle.

What Does a Notified Body Do?

A Notified Body acts as a gatekeeper to the European medical device market. Unlike government regulatory agencies (such as the MHRA in the UK or BfArM in Germany), Notified Bodies are private entities that have been accredited to conduct conformity assessments. These assessments certify that a medical device meets EU MDR requirements before it can bear the CE mark and be legally placed on the market within the European Economic Area (EEA). These assessments determine whether a medical device meets EU MDR requirements before it can bear the CE mark and be legally sold within the European Economic Area (EEA).

Core Responsibilities of a Notified Body

Evaluating Technical Documentation for Compliance
A Notified Body rigorously examines the technical file of a medical device to ensure it meets the stringent General Safety and Performance Requirements (GSPR) of MDR. This includes:

Reviewing risk assessments, design specifications, and manufacturing processes
Ensuring all safety measures and clinical evidence are properly documented
Checking that post-market surveillance (PMS) and vigilance procedures are in place

Auditing Quality Management Systems (QMS)
Most Notified Bodies conduct ISO 13485 audits, ensuring that manufacturers maintain a robust Quality Management System (QMS). This includes:

Examining production and quality control procedures
Verifying compliance with ISO 13485:2016 requirements
Assessing how well manufacturers handle corrective and preventive actions (CAPAs)

Reviewing Clinical Evaluation Reports (CERs)
Clinical data is a core requirement under MDR, and Notified Bodies must review the Clinical Evaluation Report (CER) to confirm the safety and efficacy of a device. The review includes:

Analysing clinical trial data or literature reviews
Checking compliance with MEDDEV 2.7/1 Rev 4 and MDCG 2020-6, MDCG 2020-13 guidelines
Ensuring real-world evidence supports claims made by the manufacturer

Issuing CE Certificates and Conducting Post-Market Surveillance
If a device meets MDR requirements, the Notified Body grants a CE certificate, allowing it to be marketed within the EU. However, MDR also mandates that Notified Bodies:

Perform regular surveillance audits to ensure ongoing compliance
Monitor post-market clinical follow-up (PMCF) activities
Ensure that any reported adverse events or device modifications are appropriately managed

Conducting Unannounced Audits and Verifying Product Consistency
Under MDR, Notified Bodies are required to perform unannounced audits, meaning manufacturers must always be prepared for compliance checks. These audits ensure:

Devices being manufactured are consistent with those approved for CE marking
There are no unauthorised changes to materials, design, or production processes
Proper labelling, UDI (Unique Device Identification), and traceability systems are in place

Why Choosing the Right Notified Body Matters

Selecting a Notified Body is not just about obtaining certification - it is about ensuring a smooth compliance journey throughout the entire product lifecycle. A poorly chosen Notified Body can result in:

Significant delays in market access
Unexpected costs due to excessive audit findings or inefficiencies
Regulatory setbacks if the Notified Body lacks experience in a specific device category
Increased risk of non-conformance, leading to product recalls or legal penalties

A strategic approach to selecting the right Notified Body will ultimately save time, reduce regulatory risks, and ensure seamless market entry.

Factors to Consider When Selecting a Notified Body

Not all Notified Bodies are the same. Some specialise in high-risk devices, while others focus on lower-risk classifications. Choosing the wrong NB can lead to delays, increased costs, and regulatory roadblocks. Below are the key factors every manufacturer must consider.

1. Scope of Designation and Expertise

Notified Bodies are not all accredited for the same types of medical devices. Each NB is assigned specific MDR designations, often classified using MDR codes. These define the device categories a Notified Body is allowed to assess.

Before selecting an NB, manufacturers must:

Check the European Commission’s NANDO Database (https://ec.europa.eu/growth/tools-databases/nando/) – This lists all Notified Bodies and their scope of designation.
Ensure the NB is accredited for the correct MDR code – Engaging a Notified Body that lacks expertise in your device type will result in wasted time and effort.
Evaluate their knowledge of specific device technologies – Some Notified Bodies specialise in software as a medical device (SaMD), while others focus on implantable devices.

💡 Pro Tip: If your device is innovative or falls under a niche category (e.g., AI-driven diagnostics, combination drug-devices), you need an NB with specific expertise in your field.

2. Experience with Similar Device Classifications

Even if an NB is designated for a specific device category, their practical experience matters. Manufacturers should assess:

The number of similar devices the NB has certified
How many high-risk (Class III) certifications they have issued
Their familiarity with relevant clinical and regulatory challenges

3. Review Speed and Efficiency

Under MDR, certification timelines have significantly increased. The time required varies based on device classification and clinical data requirements, but the average certification process now takes 12–18 months, compared to 6–9 months under the MDD. Some Notified Bodies have backlogs exceeding 24 months.

Key questions to ask before engaging an NB:
✔ How long is the queue before assessment begins?
✔ What are the average approval timelines for a device of my classification?
✔ What percentage of applications are approved on the first submission?

💡 Pro Tip: If an NB has a backlog exceeding one year, consider alternative options or strategies to expedite the process.

4. Cost and Service Fees

Notified Bodies charge fees for:

Initial application processing
Annual surveillance audits
Change notifications (if the device is modified post-approval)

NB fees can vary significantly. Some charge flat rates, while others bill per review hour. Manufacturers should obtain detailed pricing quotes upfront to avoid hidden costs.

5. Geographic Location and Accessibility

Although CE marking is an EU-wide system, the location of a Notified Body can influence:

Audit logistics – Travel costs for on-site inspections
Ease of communication – Time zones and language barriers
Familiarity with national regulatory nuances

💡 Pro Tip: If your company is based outside the EU, choosing an NB with strong international experience can streamline the approval process.

6. Reputation and Industry Feedback

Manufacturers should research:

An NB’s track record in handling complex devices
Their transparency and responsiveness
Feedback from other manufacturers

Checking industry forums, regulatory bodies, and trade associations can help verify an NB’s reliability and consistency.

7. Level of Support and Communication

The MDR process is complex, and some NBs offer more support than others. Manufacturers of in vitro diagnostic devices should also consider the requirements of IVDR (EU 2017/746), which has its own Notified Body designation process. Look for:

Pre-assessment services – Helps identify compliance gaps before formal submission
Training workshops – Guides manufacturers through MDR updates
Regular updates – Keeps companies informed of regulatory changes

💡 Pro Tip: Select an NB that offers strong communication channels, ensuring a collaborative and transparent relationship.

Challenges in Obtaining CE Marking Under MDR

Obtaining CE marking for medical devices under the EU Medical Device Regulation (MDR 2017/745) is a far more rigorous and time-consuming process than under its predecessor, the Medical Devices Directive (MDD). The MDR places a much greater emphasis on clinical evidence, risk management, and post-market surveillance, significantly raising the bar for manufacturers seeking compliance. Below are some of the key challenges companies face when navigating the MDR landscape.

1. Increased Scrutiny and Regulatory Burdens

The MDR introduces far stricter conformity assessment requirements, making it one of the most demanding medical device regulations in the world. Manufacturers must be prepared for:

Enhanced Clinical Data Expectations

Clinical evaluation requirements have been tightened considerably. Many devices that previously required little or no clinical investigation under MDD must now demonstrate robust clinical evidence that supports their safety and performance. This includes:

More rigorous clinical trials – Manufacturers must provide real-world clinical data where applicable.
Stronger justifications for equivalence claims – If a manufacturer is relying on existing clinical data from a similar device, it must prove it has full access to the original data and that the devices are identical in all relevant aspects.
Continuous post-market clinical follow-up (PMCF) – Once a device is approved, manufacturers must implement an ongoing clinical data collection strategy to detect long-term risks.

Additional Expert Panel Reviews for High-Risk Devices

For specific high-risk devices, particularly some Class III implantable devices (Article 54, MDR), the regulation requires an independent expert panel to review the Notified Body’s conformity assessment before certification. This extra layer of scrutiny can result in:

Longer approval times – Additional review cycles extend the certification process.
Stricter clinical evidence expectations – The expert panel can request more extensive data before granting approval.

💡 Manufacturers should anticipate longer review times and invest heavily in clinical validation to meet these heightened regulatory expectations.

2. Notified Body Capacity Constraints

One of the most pressing challenges under MDR is the severe shortage of designated Notified Bodies. When MDR replaced MDD, all existing Notified Bodies had to reapply for designation under the new, stricter rules. Many either failed to meet the new criteria or opted not to continue offering medical device certification services.

Impact on Manufacturers

Fewer Notified Bodies Available – Under MDD, there were around 80 Notified Bodies. Under MDR, this number has dropped to fewer than 50.
Severe Backlogs – Most Notified Bodies now have long waiting lists for new applications. Some manufacturers report delays of 12-24 months before their review even begins.
Increased Costs – With fewer NBs available, demand has skyrocketed, leading to higher fees for certification services.

Why Early Engagement is Crucial

Given the backlog, manufacturers must secure a Notified Body as early as possible. Waiting until late in the development cycle can result in missed market launch deadlines or even loss of market access if existing MDD certificates expire before MDR certification is granted.

💡 Tip: Approach multiple Notified Bodies early to secure a contract. If your first choice has a long queue, having a backup option can prevent costly delays.

3. Common Pitfalls to Avoid

Manufacturers navigating MDR should be aware of common mistakes that can derail or delay CE marking approval:

Underestimating MDR Timelines

One of the biggest pitfalls is assuming the MDR certification process will take a few months, similar to the old MDD system. In reality:
The MDR process now takes 12-18 months on average, and longer for high-risk devices.

Complex devices requiring clinical investigations can face delays of up to 24 months.

💡 Manufacturers should factor in regulatory timelines when planning product launches to avoid costly delays.

Incomplete or Poorly Organised Documentation

Notified Bodies are extremely strict about technical documentation under MDR. The most common causes of rejection include:

Missing clinical data – Inadequate real-world performance data leads to non-conformities.
Disorganised files – NBs expect clear, structured submissions following MDR Annex II requirements.
Gaps in risk management documentation – Failing to provide a comprehensive risk-benefit analysis can trigger rejection.

💡 Tip: Before submission, conduct an internal audit to check for documentation gaps. Investing in an external regulatory expert can help identify weaknesses.

Misclassification of Devices

Misclassifying a device can lead to significant regulatory setbacks. Under MDR:

Many previously low-risk devices have been reclassified into higher-risk categories.
Software-based devices and some diagnostic tools now require Notified Body involvement.
Incorrect classification results in delays and extra costs if an NB requires a manufacturer to resubmit using the correct classification.

💡 Tip: Carefully review MDR’s classification rules before starting the conformity assessment process.

Failing to Prepare for Post-Market Surveillance (PMS)

Unlike MDD, where PMS was often seen as an afterthought, MDR requires PMS to be in place before certification is granted.

Manufacturers must submit PMS plans with their initial application.
Lack of a clear strategy can lead to rejection or additional review cycles.

💡 Tip: Develop a PMS plan early and ensure it aligns with MDR’s data collection and reporting expectations.

4. Selecting the Right Notified Body for MDR Compliance

With limited Notified Bodies available, manufacturers must carefully evaluate their options based on:

Expertise and Scope of Designation

Ensure the Notified Body is designated for your specific device type.
Check whether they have experience certifying similar devices.

Review Timelines and Capacity

Ask about the current backlog and expected certification timeline.
Consider whether the NB has sufficient resources to handle your application efficiently.

Reputation and Industry Feedback

Seek feedback from other manufacturers who have worked with the NB.
Look for an NB that is known for clear communication and regulatory expertise.

💡 Tip: Some Notified Bodies are better suited for high-risk devices, while others focus on software, diagnostics, or surgical instruments. Choose accordingly.

5. Best Practices for a Successful CE Marking Process

To navigate MDR efficiently and avoid delays, manufacturers should adopt the following strategies:

Start Early

Engage a Notified Body at least 12-18 months before expected certification.
Conduct MDR gap assessments to identify compliance weaknesses.

Ensure Robust Documentation

Follow MDR Annex II for technical documentation formatting.
Invest in regulatory expertise to ensure high-quality submissions.

Communicate Proactively with Your Notified Body

Establish a strong working relationship with your NB to prevent misunderstandings.
Address any issues or non-conformities as quickly as possible.

Prepare for Long-Term Compliance

MDR compliance is not a one-time event - it requires continuous monitoring and reporting.
Ensure post-market surveillance, risk management, and clinical follow-up plans are in place before approval.

Final Thoughts

The transition to MDR compliance is challenging, but with the right approach, manufacturers can successfully navigate the process. By planning ahead, engaging a Notified Body early, and ensuring documentation is complete and well-structured, companies can reduce approval times, avoid common pitfalls, and secure market access for their medical devices in Europe.

Steven Clarke