Step 1 – Define the intended purpose

The first step is to define your device’s intended purpose. The intended purpose determines whether your product qualifies as a medical device under the MDR. It also specifies the regulatory requirements your product must meet.

Incorrectly defining the intended purpose of a medical device can cause huge problems further down the line. A common pitfall is the misclassification of a wellness or fitness product as a nonmedical device when it contains a medical function. For example, a fitness tracker that also detects ECG irregularities. 

The good news is that our experts can assist with correctly defining and documenting the intended purpose of your medical device. They also make sure your claims are carefully aligned with MDR guidelines, helping you avoid costly misclassification issues.

Step 2 – Identify the risk class

Once you've established the intended purpose, the next step is to classify your device under MDR’s risk categories: Class I, IIa, IIb, or III. The classification determines the level of regulatory scrutiny and whether you need a Notified Body to assess compliance.

To get this right, it’s important to study the classification guidance documents from the Medical Device Coordination Group (MDCG). That’s because underestimating the risk class can be a major pitfall, especially when you assume a device qualifies for self-certification when it actually requires assessment by a Notified Body. 

To help you, not only do we offer Quick Scan – a free MDR classification tool – our consultants are continuously kept updated with the latest MDCG guidance to ensure your product is correctly classified. Their expertise can prevent delays and mitigate the costs and delays associated with incorrect classification.

Step 3 – Understand which compliance rules apply

With your device classified, the next step is to identify all applicable General Safety and Performance Requirements (GSPR) under the MDR. These requirements outline the standards your device must meet. In addition, manufacturers of medical devices need to comply with the obligations stated in Article 10 of the MDR. 

For established companies, thorough verification is necessary to ensure any existing quality management processes meet the stringent MDR requirements. Similarly, newer companies like startups will need a detailed understanding of the compliance rules and regulations. 

The great thing about Peercode is that our regulatory consultants can work with you to map out the specific requirements that apply to your product and guide you in preparing the necessary documentation. They will also clarify whether you need Notified Body approval.

Step 4 – Prepare your QMS and technical file

A robust Quality Management System (QMS) is essential to comply with the MDR. If your device requires Notified Body approval, your QMS must align with ISO 13485. Alongside your QMS, you must also prepare a technical file containing all the required documentation as per Annex II of the EU MDR.

Lack of early management buy-in can result in underfunded compliance efforts. This in turn can delay the time to market. It’s important not to underestimate the time and resources needed to develop and implement an MDR-compliant QMS. At the same time, poorly structured or incomplete technical files can lead to repeated rejection by the Notified Body.

To avoid unnecessary costs and delays, our expert team can help you set up an MDR-compliant QMS, ensuring your technical file is complete before submission. We can also provide guidance on structuring documentation correctly, reducing the risk of extensive revisions.

Step 5 – Implement testing and reporting

Once all risk controls are defined and implemented, the next step is testing. If your test results show the risk controls are ineffective or the product does not meet safety and performance requirements, or it does not perform as well as an equivalent product, you may need to revisit the design and risk management process. 

This iterative process can take time, but it’s essential for both compliance and product reliability. It’s crucial to establish traceability so that for every product requirement, there is a corresponding test and documented evidence of its fulfillment. For that reason, a structured testing strategy is key.

Our consultants can assist in designing and validating testing strategies, advising on required tests, selecting suitable testing partners, and ensuring that planned tests are sufficient. We also have in-house expertise in software-based products.

Following testing, all results need to be consolidated into reports that confirm regulatory compliance and support the product’s technical file. This process is similar to writing a scientific thesis: stating a hypothesis, defining methods, executing tests, analyzing results, and reporting conclusions. 

These reports demonstrate that the product meets its intended requirements and regulatory expectations, forming the foundation for submission to a Notified Body. It’s important not to underestimate the time it takes to prepare the technical dossier. Depending on the product, its intended purpose, and its risk class, a rough estimate is between 400 and 600 hours.

Step 6 – Submission to a Notified Body

Once testing and documentation are complete, the next step is submission to a Notified Body. It is advisable to engage with a Notified Body early in the process, as not all Notified Bodies cover all product types, and many have long waiting lists. Typically, companies initiate contact at least three months before the planned submission, but if starting from scratch, it may be beneficial to engage up to a year in advance.

Applying to a Notified Body involves submitting an extensive application form, specifying the product type, risk classification, and required standards. Only after reviewing this documentation does the Notified Body confirm if they can assess the product. Given the current high demand, waiting times can range from one to two years. However, gaps can come up in the review schedule, allowing for earlier assessments.

Selecting the right Notified Body is crucial. Some larger Notified Bodies follow rigid procedures, while smaller ones may offer a more personalized approach. After submission, the Notified Body may request clarifications or modifications. Typically, companies have three chances to address feedback before their application is rejected. The good news is our pre-assessment services can help identify and rectify potential gaps before submission, reducing the risk of delays.

Once any issues are resolved, your Notified Body issues the necessary certification, allowing you to affix the CE mark and launch your product in the market. This milestone marks the end of the regulatory approval process and the beginning of ongoing compliance and audit cycles. 

Got the CE mark? That’s just the start

Maintaining a good relationship with your assigned point of contact at the Notified Body is essential, as they facilitate communication and scheduling. They’ll also work alongside you going forward when it comes to Post Market Surveillance (PMS). 

Given the complexity of the compliance journey, expert guidance and early planning significantly enhance your chances of a straightforward go-to-market. And that’s where Peercode Regulatory Consultancy comes in. We can help you to:

• Define the intended purpose
• Identify the risk class
• Understand which compliance rules apply
• Prepare your QMS and technical file
• Implement testing and reporting
• Submit to a Notified Body

Need help to navigate the complexities of regulatory compliance for medical products? The experts at Peercode Regulatory Consultancy are here to help. 

Get in touch or connect with us on LinkedIn