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Getting the Support You Need at Every Step of the CE Marking Process

CE marking provides access to a market of over 500 million consumers across all 27 member states of the European Union (EU), as well as Iceland, Norway, and Liechtenstein. For medical devices and in vitro diagnostics (IVDs), a CE mark is a must for placing products on the market. With the implementation of the EU Medical Devices Regulation (MDR) and In Vitro Diagnostics Regulation (IVDR), the regulatory framework has undergone a major overhaul, with stricter pre-market requirements, increased notified body involvement, and a greater emphasis on clinical evidence.

In our experience, manufacturers seeking CE certification for their products often encounter challenges that can delay or complicate the CE marking approval process. A key to success is recognizing and avoiding common mistakes such as:

  • Misclassifying the product, leading to selection of the wrong conformity assessment route
  • Misunderstanding the applicable regulations, standards, or guidance documents
  • Submitting incomplete or poorly organized technical documentation that fails to demonstrate conformity with the relevant regulatory requirements
  • Providing insufficient clinical or performance evidence
  • Overlooking post-market surveillance and vigilance requirements
  • Underestimating the important of a quality management system (QMS)
  • Failing to engage with a suitable notified body early in the development process

Increasingly, manufacturers are turning to consultants with regulatory expertise to help them navigate the CE marking process. These consultants can assist with:

1. Determining the classification for your medical device or IVD

The classification or your medical device or IVD according to the risk-based classification systems defined in MDR and IVDR, respectively, will determine the conformity assessment route and requirements for CE marking.

2. Identifying the applicable standards and guidance documents

An understanding of the applicable regulations, standards, and guidance documents is essential for complying with legislation and completing the application for the EU notified body for CE certification.

3. Reviewing your existing technical documentation

Technical documentation must comply with the General Safety and Performance Requirements (GSPRs) of either MDR or IVDR, depending on your device type.

4. Reviewing your existing Technical File or Design Dossier

The objective of this review is to identify and, if necessary, address any gaps in your technical documentation.

5. Reviewing your existing policies and procedures

CE marking requires the implementation of a QMS that meets the requirements of ISO 13485 and complies with Article 10 of MDR or IVDR, depending on your device type.

For medical devices, the QMS must include clinical evaluation, post-market surveillance (PMS), and post-market clinical follow-up (PMCF) plans. For IVDs, the QMS must include performance evaluation, post-market clinical follow-up (PMS), and post-market performance follow-up plans.

The goal of this review is to identify and, if applicable, address any gaps in your QMS.

6. Acting as your European Authorized Representative (EC REP)

In accordance with Article 11 of MDR or IVDR, manufacturers that do not have a physical location in Europe must have an EC REP to act on their behalf in the EU.

7. Assisting with EU notified body selection

Under MDR and IVDR, the role of notified bodies has been expanded, with more stringent requirements for their designation and heightened scrutiny of their assessments. It is critical to identify, select, and qualify a notified body that has experience in your product category and capacity to handle your application in a timely manner.

8. Helping with your application for CE certification

The application for CE certification comprises several key components, including a draft Declaration of Conformity (DoC), comprehensive QMS policies and procedures, technical documentation, instructions for use (IFU), and product labeling. The notified body may ask for additional information, and it is important to stay abreast of any changes in regulations, standards, or guidance documents that may affect compliance.

At Premier Consulting, we provide regulatory guidance throughout the product lifecycle, from investigational product through approval and post-market support. Often, our knowledgeable team of medical device and IVD consulting subject matter experts (SMEs) are called upon to perform gap analyses of technical documentation and to review technical files and design dossiers in support of applications for CE certification.

Gap Analysis is a high-level review of the technical documentation prepared by the manufacturer to demonstrate compliance with the relevant regulations, standards, and guidance documents. The gap analysis evaluates what is currently in place against a comprehensive checklist of regulatory requirements to pinpoint gaps in the technical documentation. This exercise is pivotal to identifying any steps that must be taken to comply with the regulatory requirements prior to finalizing the technical documentation.

Technical File and Design Dossier Review is an in-depth review of the technical documentation prepared by the manufacturer. This deep dive assesses what is currently in place and documents the current level of compliance, any outstanding areas of concern, areas for potential improvement, and recommendations on actions that need to be taken to achieve the required level of compliance in advance of an application to the notified body for CE certification.

Undertaking a gap analysis followed by a technical file and design dossier review will identify any compliance issues prior to submission and allow you to remediate those issues, thereby reducing the number of non-conformities and shortening the notified body review process.

Key takeaway

Partnering with an expert regulatory consultant can help to streamline the CE marking process. At Premier Consulting, we have decades of experience in helping medical device and IVD manufacturers successfully navigate the complexities of CE certification. As regulations, standards and guidance documents evolve, we keep pace with changes in the landscape, ensuring that the manufacturers we partner with stay in compliance, both pre- and post-market.

To learn more about how Premier Consulting can help you at every step of the CE marking process, contact us.