Meeting Regulatory Requirements for Market Access

Before placing your medical device on the market, you must ensure it meets all applicable regulatory requirements. Obtaining CE marking certification is essential for accessing the European market.

Demonstrating Your Device Meets Standards

To demonstrate device compliance, you must show it meets safety and performance standards set out in applicable regulations. Therefore, the CE marking process requires thorough documentation that guarantees your device’s claimed performance and the safety of patients and users.

Your Responsibilities as a Manufacturer

As a manufacturer, you must address each applicable requirement and submit comprehensive evidence demonstrating conformity to regulatory authorities. Moreover, maintaining your CE marking certification requires ongoing compliance throughout your device’s lifecycle.

Identifying Your Medical Device Class

Before you apply for certification, you must first identify your medical device’s class. This classification directly determines which regulatory requirements apply to your product.

How Classification Works

You can determine your device class by following the classification rules outlined in Regulation (EU) 2017/745 on medical devices or Regulation (EU) 2017/746 on in vitro diagnostic medical devices. The classification process is based on three key factors: your device’s intended use, its specific characteristics, and its inherent risks.

Selecting Your Conformity Assessment Procedure

Once you identify your device class, you can then determine which conformity assessment procedure applies. In other words, this classification helps you select the right route to meet applicable requirements and demonstrate conformity with the relevant regulation.

Understanding the Requirements

Before placing your medical device on the market or putting it into service, you must first choose and implement the appropriate conformity assessment procedure to demonstrate conformity of your products. Specifically, European Regulations (EU) 2017/745 and 2017/746 lay out the rules to follow for selecting the required conformity assessment procedure for CE marking.

Determining the Right Procedure

The CE mark certification assessment procedure depends on your device’s intended use, risk class, and characteristics. Additionally, it depends on your choice to set up a quality assurance system (complete or not). Therefore, understanding your device classification is essential for successful CE marking for medical devices.

Meeting Conformity Requirements

Once you determine the required assessment procedure, you must then meet the corresponding requirements and ensure that proof of conformity is available. Moreover, you need to compile comprehensive documentation to support your CE marking certification application.

When You Need a Notified Body

While some class I or class A devices allow self-certification, higher-risk device classes require a notified body to assess your conformity assessment evidence. Subsequently, based on the assessment results, a CE marking certificate is issued, which is required before placing the device on the market.

Why You Need Technical Documentation

European Regulations require manufacturers to establish and keep updated technical documentation. This documentation must demonstrate that your device conforms with all regulatory safety and performance requirements.

What You Must Include in Your Documentation

Your technical documentation must cover all stages of the product’s life cycle, from the device’s design through to its disposal. Additionally, you need to include proof of conformity for each applicable regulatory provision.

How Technical Documentation Serves You

The technical documentation allows you, as the manufacturer, to provide all the information about the device for your own use. Furthermore, this documentation remains available to authorities and to GMED in the framework of conformity assessment applications.

The Purpose of Your Technical Documentation

Technical documentation clearly presents the device, its characteristics, and expected performance, enabling independent organizations to fully understand conformity evidence. Additionally, this documentation includes validations, test reports, and other supporting documents.

Why You Need a Declaration of Conformity

Before you can place your device on the market or put it into service, regulatory requirements mandate that you must establish an EU declaration of conformity. This step is essential for legal market access.

What the Declaration Represents

As the manufacturer, you must issue the declaration of conformity under your sole responsibility, formally attesting that your product fulfills all applicable regulation provisions. This declaration serves as your official commitment to compliance and product safety.

Ready to Place Your Device on the Market?

Once you meet all requirements, the notified body issues your CE marking certificate. As the manufacturer, you can then affix the CE marking to your device and place your product on the market.

Need More Information?

Furthermore, we offer extensive resources to support your certification journey. Visit our Knowledge Center where you’ll find practical guides, regular updates, and informative articles about CE mark certification and CE marking for medical devices.

The CE Mark certification process consists of 6 main phases: Pre-application stage, Conformity assessment application, Conformity assessment activities, Certification decision, Post-certification company surveillance, and Recertification.

There are 6 key elements: Demonstrate conformity, Identify the class of medical device, Choose and implement a conformity assessment procedure, Compile technical documentation, Establish the EU declaration of conformity, and Placing on the market.

GMED provides CE Mark certification for Medical Devices (MDD), In Vitro Diagnostic Medical Devices (IVD), and Electromedical Devices (EMD).