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CE Mark For Medical Devices

Oriel STAT A MATRIX has helped hundreds of companies successfully complete the steps necessary to obtain CE Marking and begin commercializing their medical devices in the EU.

CE Mark Consulting

Marketing a medical device or IVD in the European Union (EU) requires the manufacturer to show compliance with the applicable requirements.

The EU requirements apply to all Member States and any manufacturer wishing to place medical devices on the market in the EU. By obtaining CE Marking, the manufacturer demonstrates that the device meets these requirements.

It is critical to understand the requirements and develop a solid regulatory strategy for the device’s entry into the EU. CE Marking a medical device can also be helpful to leverage registration in other countries around the world.

From the 1990s to 2017, the EU requirements were found in the Medical Device Directives. In 2017, the EU published two new regulations that will replace these directives over a multiyear period.

New EU Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR)

In May 2017, the European Union (EU) published two new regulations: the Medical Device Regulation (MDR) and the In Vitro Diagnostic Regulation (IVDR). These new regulations will replace the three existing EU directives covering active implantable medical devices, medical devices, and IVDs.

Medical device manufacturers will have a 3-year transition period, and IVD manufacturers will have a 5-year transition period. Learn more.

Complete the steps to get your medical device or IVD on the market in the EU more quickly with Oriel STAT A MATRIX’s medical device industry experts. 

CE Mark support includes: 

  • Determining the classification, regulatory pathway, and applicable regulation (MDR/IVDR) for your device.
  • Performing a gap assessment of existing technical documentation that supports safety and performance against the requirements of the applicable regulation.
  • Compiling the necessary technical documentation to support the General Safety and Performance Requirements (GSPR), including device information, clinical evaluation, and risk assessment.
  • Evaluating or implementing an ISO 13485-compliant quality system.
  • Preparing for the Notified Body inspection of the quality system and review of the technical documentation.

 

You must affix a valid CE Mark to your medical device or IVD before placing the finished device on the market in the EU. The CE Mark is a statement that the device conforms to the applicable EU requirements.

Currently, the requirements are found in the directives: Medical Device Directive (MDD 93/42/EEC), In Vitro Diagnostic Device Directive (IVD 98/79/EC), or Active Implantable Medical Device Directive (AIMD 90/385/EEC). In 2017, the EU published two new regulations that will replace these directives over a multiyear period.

New EU Medical Device Regulations (MDR) and In Vitro Diagnostic Regulations (IVDR)

As noted above, in May 2017, the European Union (EU) published two new regulations: the Medical Device Regulation (MDR) and the In Vitro Diagnostic Regulation (IVDR). These new regulations will replace the three existing EU directives covering active implantable medical devices, medical devices, and IVDs.

Medical device manufacturers will have a 3-year transition period, and IVD manufacturers will have a 5-year transition period. Learn more.

CE Marking requirements in the new EU regulations include:

  • Characterize the product as a medical device and determine the applicable requirements.
  • Determine the class for your product (Class I, Class IIa, Class IIb, or Class III for medical devices; Class A, Class B, Class C, or Class D for IVD devices).
  • Identify the appropriate conformity assessment procedure required to obtain the CE Mark. The device classification determines the appropriate conformity assessment procedure, so it is critical to determine the correct classification from the start.
  • Demonstrate conformity of the quality system with the applicable requirements. Many manufacturers meet this stipulation by showing conformity with ISO 13485/EN ISO 13485 – an internationally recognized management standard.
  • Compile the technical documentation needed to satisfy the requirements. This documentation should contain all of device information, specifications, test data, and design activities related to the device or IVD.
  • Prepare a Declaration of Conformity. This statement affirms that the device meets safety and performance requirements; has undergone the appropriate conformity assessment procedures; and was designed, manufactured, and tested in accordance with its technical documentation.

You must have all these elements in place before the Notified Body (NB) will recommend/approve a device for CE Marking, and you must provide evidence of these elements in your technical documentation.

Additional steps in the new EU regulations that pertain to use of a CE Mark include:

  • Appoint a European Authorized Representative (AR) if the company has no physical location in Europe. The AR is a regulatory liaison with Competent Authorities. The AR both ensures that the device is CE Marked legally and has permanent access to the device’s technical documentation.
  • Select a Notified Body (unless your device can be self-certified). This step is critical, as the NB will be your partner through this process. The NB will conduct a full conformity assessment (including performing on-site audits and reviewing technical documentation) to determine your product’s conformance with the general safety and performance requirements.
  • Affix the CE Mark to your product labeling and issue the Declaration of Conformity.
  • In the future, as the EU transitions to the new regulations, manufacturers will need to register their establishment and any medical device or IVD that they plan to place on the EU market. Manufacturers will complete this step in the EUDAMED system, where they will receive a Single Registration Number (SRN).

After placing a CE Marked product on the market, the new EU regulations require manufacturers to:

  • Ensure that the distribution chain is established, as there are specific requirements for importers and distributors of medical devices in the EU.
  • Establish and implement a postmarket surveillance system, including any necessary vigilance reporting of field safety notices.
  • Maintain the finished medical device throughout its full life cycle, from clinical evidence, customer feedback, and updates to hazards to end of life.
  • Maintain design and manufacturing changes throughout the product life cycle and understand their impact on current general safety and regulatory requirements.
  • Maintain a quality system that supports the safety and performance of medical devices, and continuously improve the system’s effectiveness.

These requirements take time and expertise to address properly. Oriel STAT A MATRIX’s medical device industry experts can help your company complete these steps correctly and efficiently, so you can get your medical device or IVD on the market in the EU more quickly.

Select a course below to learn more or to register.
 
Course Name Public On-site
NEW!   Transition to the New EU Medical Device Regulation (MDR)
Quality Systems for Medical Devices:
FDA’s QSR and ISO 13485:2016
Updated!   Medical Device Submissions in the US and EU [Emphasizing 510(k) and CE Mark]

In this new 2-day course you will learn about the new requirements in the MDR and how to plan an efficient transition. Click to learn more.

Gain a solid understanding of the necessary components of an effective, compliant quality system for medical device manufacturing. Click to learn more.

Learn about the available options for bringing a device to market in the US and/or EU. Click to learn more.

Provided below are a variety of practice related white papers, market updates and case studies.

The New EU Medical Device Regulations: What You Need to Know

Pathfinder for the New EU MDR and IVDR

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