Before you can offer your medical products to nations within the European Union (EU) and the European Free Trade Association, you must first satisfy the requirements for CE Marking, a conformity mark that signifies a product has met all criteria of the relevant EU directives, especially in the areas of Safety and Performance.
Gain market access to Europe
LNE/G-MED North America can assess a wide variety of Medical Devices under the following relevant Directives:
• Active Implantable Medical Devices (AIMD) (90/385/EC modified by the directive 2007/47/EC)
• In Vitro Diagnostic Medical Devices (IVDD) (98/79/EC)
• Medical Devices Directive (MDD) (93/42/EEC; modified by 2007/47/EC), including:
LNE/G-MED is the sole French notified body for the European Directives covering medical devices. It is notified by the French authorities (identification no. 0459) to the European Union member states and the European Commission for the following Directives:
- Directive 90/385/EEC covering active implantable medical devices modified by the directive 2007/47/CE
- Directive 93/42/EEC covering medical devices modified by the directive 2007/47/CE
- Directive 98/79/EC covering in vitro diagnostic medical devices
- Directive 2000/70/EC covering medical devices incorporating stable derivate of human blood or human plasma
- Directive 2003/32/EC covering medical devices utilizing tissues of animal origin
Its notification covers:
- All categories of medical devices
- All conformity assessment procedures:
- type approval
- approval of quality management systems
- EC verification
CE Marking: 5 Key Stages
While CE Marking requirements can seem overwhelming, LNE/G-MED educates and reassures its clients on the process and provides direct access to a locally-based certification project manager, along with a dedicated production manager, available throughout the certification process.
Regardless of your organization’s size, product types or location, our mission is to ensure you get the responsive attention and necessary support to facilitate your certification. Some of the major steps in this process include:
Confirm Medical Device Status and Class
You must further categorize your device into classes (I, IIa, IIb, III for Medical Devices / List A and B for IVD Devices) based on their level of risks. Other directives could also apply such as in the case of products containing human blood derivatives, animal tissues, pharmaceuticals (i.e., combination devices) or electrical elements.
With its experience reviewing a wide range of medical devices, LNE/G-MED will assess your rationale to confirm the status and classification of your product, ensuring you start the process off right.
Identify and Meet Essential Requirements
Under EU regulations, your Medical Device is required to be deemed acceptable in terms of certain key areas:
- Appropriateness for intended use,
- Acceptable risk vs. benefit,
- Effect of transport/storage,
- Labeling and other device-specific elements
Ultimately, the end goal is the Demonstration of Compliance to the Essential Requirements.
Also called the Technical file, the information demonstrating Conformity and satisfying the criteria from the Harmonized Standards includes the:
- Product Description and Specifications
- Manufacturing Information
- Risk Management file
- Design Verification and Validation Test reports
- Clinical Evaluation
As a separate service, LNE/G-MED operates a state-of-the-art testing facility for manufacturers who request independent product testing, which can support the demonstration of compliance to the Essential Requirements.
Using a review of the Technical Documentation, or Design Dossier in the case of Class III or Active Implantable Medical Devices, or List A and B for IVD devices, our reviewers can assess the validity of your Testing process without repeating testing.
The classification of the medical device determines which assessment route a manufacturer may take for CE mark. These routes will involve some of the following elements:
- Full Quality Assurance System
- Type/Design Examination
- EC Verification
- Quality Assurance System for Production
- Quality Assurance System for Product (excludes IVD and AIMD devices)
- Declaration of Conformity (“Self-Certification”)
- Batch Release (specific to IVD devices)
The choice of the assessment route dramatically affects the complexity and scope of the assessment. This is why an accurate classification of medical device is so critical upfront.
Declaration of Conformity
This final step is the statement by which a manufacturer affirms that its device meets all essential requirements, has undergone the appropriate conformity assessment procedures and is designed manufactured and tested in accordance with technical documentation.