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CE Marking Medical Devices

Class I or IIa Medical Device CE Mark Applications on Your Behalf

As part of the overall concept-to-completion service, Europlaz can support the regulatory CE marking processes for medical devices. CE marks (and UKCA marks by extension) are critical to the trade of medical devices in the EU and the UK. Our team provide regulatory application and support as part of the complete Europlaz development cycle, ensuring you work with the same team from initial prototyping to final production.

Our CE mark services range from individual Technical File elements such as testing and production documentation to managing the complete CE Marking process, including the generation and ongoing maintenance of the Technical File.

In order to apply a CE mark to a medical device, it is necessary to demonstrate the device meets the requirements of the appropriate Medical Device Directive/Medical Device Regulation by following the relevant, comprehensive conformity assessment procedures.

To find out more contact our team and get your medical device development journey started today.

CE Marking Medical Devices
CE Marking process in detail

How to get a CE Certification for your Medical Devices

To qualify your medical device or product for CE marking certification, you need to determine the intended use of the product.

Clearly and concisely define the intended use of the product.

  • What medical condition is the product intended to diagnose or treat?
  • What is the mode of action of the product?
  • Who is the intended user (layperson / professional)
  • What patient population will the product treat?

These questions will help determine if your product falls under the CE medical device mark requirements. If you need a hand determining whether you need CE certification for a medical device, please feel free to contact us and we can help with a wide range of medical device manufacturing services.

Determine the Risk Classification the Product falls into

The Medical Device Directive / Medical Device Regulations detail the rules for determining the classification of the product. These classification rules are based on risk and include examples of factors that influence the associated risk.

There are four classification categories to certify medical devices for CE marking:

  • Class I is the lowest risk category
  • Class IIa is considered low to medium risk
  • Class IIb is medium to high risk
  • Class III is the highest risk category

In addition, there are 2 sub-classes for Class I: Class I devices that are sterile and Class I devices that have a measuring function.

Find out more about the changes to risk classifications in the UK following Brexit and in the EU following the introduction of the EU MDR here.

CE Marking Risk Classification
CE Marking Medical Devices

Determine Compliance with the Essential / Safety & Performance Requirements

The Medical Device Directive / Medical Device Regulations detail the Essential / Safety and performance requirements for all classes of medical devices, and includes requirements for safety, performance, design and construction, as well as labelling and instructions for use. If the Requirement is applicable to the Device in question it must be complied with.

Determine the appropriate Conformity Assessment Procedure

The Annexes of the MDD / MDR details the various procedures for demonstrating conformity and it is the responsibility of the manufacturer to choose the appropriate procedure based on the classification of the product. The choice of assessment route dramatically affects the complexity and scope of the assessment. Therefore an accurate classification of the device is a critical upfront step in the assessment process.

CE Marking Medical Devices
Business women checking Technical Documentation

Compile the Technical Documentation

A Technical File must be compiled describing the design and manufacture of the product, and the objective evidence to demonstrate how conformity with each of the applicable requirements has been achieved.

Read more about the technical files required for CE medical device certification here.

Implement Post-Market Surveillance

In order to ensure incidents in the market are assessed and, where applicable, reported to the national competent authority a Post Market surveillance system must be implemented. This process reviews all information gained once the device is being used in the market and ensures key information is fed back into the ongoing risk analysis in the technical file.

Post Marketing Surviellance
CE Marking Medical Devices

Issue the Declaration of Conformity and Affix the CE Mark

Once all other steps to qualify your medical device for CE marking have been satisfactorily completed and approved, a declaration of conformity to the Medical Device Directive / Regulation is made. This affirms that the device meets all of the applicable essential / safety and performance requirements, has undergone the appropriate conformity assessment procedure and is designed, manufactured and tested in accordance with the Technical documentation. A ‘Declaration of Conformity’ to the MDD / MDR can be generated and signed, and the CE Mark applied to the device so that it can be sold throughout the EU.

About Europlaz

Since 1970 we have built a reputation for innovation, quality, and cost-effectiveness.

We use our experience and state-of-the-art technology to streamline all stages of the medical device manufacturing process for you – moving your product quickly and safely through development, and speeding up regulatory approval of medical devices.

Our UK-based ISO 13485 certified and FDA-compliant facility means that we have complete control of the process, from under one roof. We are flexible, and resourceful, and can take on projects of any size. Our clients range from small start-ups to international blue chip medical device suppliers.

For further information you can watch our Corporate Video to the left-hand side, view our Corporate Brochure or Contact Us.

Book a Meeting

To learn more about Europlaz’s services and the different medical devices we have helped develop, book a telephone meeting with one of the team.

To do this simply use the Schedule Meeting button below.

Alternatively you can contact us by telephone or email.

01621 773471

All Other Services

Medical Device 3PL

Assisting with the entire logistic process from manufacturing, storage, picking to shipping.

Renting R&D Space

For clients who are undertaking advanced stage R&D work and require our facilities and services.

Sterilisation

Understand our Ethylene Oxide, Gamma and Auto Clave sterilisation process.

Risk Management

Providing you with a risk management plan to ensure all risks are identified, managed and mitigated.

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