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CE Mark For Medical Devices

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

CE Mark Consulting

Marketing a medical device or IVD in Europe requires the manufacturer to show compliance with the applicable directive. By obtaining CE Marking, the manufacturer demonstrates that the applicable requirements for the device have been met.

It is critical to understand the regulations and develop a solid regulatory strategy for the device’s entry into the EU.

CE Mark support includes: 

  • Determining the classification, regulatory pathway, and applicable directive (MDD/AIMD/IVDD) for your device.
  • Performing a gap assessment of existing data and documentation against the requirements of the applicable directive (MDD/AIMD/IVDD).
  • Compiling the Technical File or Design Dossier, including the clinical evaluation and risk assessment.
  • Evaluating or implementing an ISO 13485-compliant quality system.
  • Preparing for the Notified Body inspection.

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

In May 2016, European Union (EU) institutions agreed to draft text for two new regulations to replace the current Medical Device Directives: the Medical Device Regulation (MDR) and the In Vitro Device Regulation (IVDR). The new regulations are intended to harmonize and strengthen laws relating to medical devices within the EU. These regulations will affect all aspects of CE Marking, including pre- and post-market requirements, and will have a significant impact on high-risk and novel devices.

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.

A valid CE Mark affixed to your medical device or IVD denotes that it is approved for sale in the European Union. This mark indicates that the device meets the requirements of the applicable EU 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).

Requirements for receiving CE Mark approval include:

  • Characterizing the product and determining the applicable directive.
  • Determining the class for your product (Class I, Class IIa, Class IIb, or Class III for medical devices; List A, List B, Self-Testing, or Self-Certified for IVD devices). The classification of the medical device or IVD determines the appropriate conformity assessment procedure required to obtain the CE Mark. As such, it is critical to determine the correct classification from the start.
  • Demonstrating conformity of the quality system with the applicable Annex in the MDD/IVDD. Many manufacturers meet this requirement by showing conformity with ISO 13485 and ISO 14971.
  • Compiling the technical documentation (Technical File or Design Dossier) necessary to satisfy the requirements of the applicable directive. This documentation should contain all of the test data, specifications, and design information related to the device or IVD.
  • Preparing a Declaration of Conformity – the statement affirming that the device meets essential requirements; has undergone the appropriate conformity assessment procedures; and has been designed, manufactured, and tested in accordance with technical documentation. All of these elements must be in place before the Notified Body (NB) will award CE Marking, and evidence of these elements are required for the Technical File.
  • Appointing a European Authorized Representative, if the company has no physical location in Europe.
  • Selecting a Notified Body, unless your device can be self-certified. The NB will conduct a full Conformity Assessment (including conducting on-site audits) to determine your product’s conformance with the essential requirements.
  • Affixing the CE Mark to your product labeling.
  • Registering the medical device or IVD with the Competent Authorities in the countries where you plan to market the product.

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

In May 2016, European Union (EU) institutions agreed to draft text for two new regulations to replace the current Medical Device Directives: the Medical Device Regulation (MDR) and the In Vitro Device Regulation (IVDR). The new regulations are intended to harmonize and strengthen laws relating to medical devices within the EU. These regulations will affect all aspects of CE Marking, including pre- and post-market requirements, and will have a significant impact on high-risk and novel devices.

These requirements take time and expertise to address correctly. 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
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]

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.
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