5 Key Stages of CE Marking
While CE Marking requirements can seem overwhelming, LNE/G-MED America 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:
1) Confirm Medical Device Status and Class
To determine what rules apply specific devices, manufacturers must identify the applicable EU Medical directive(s) regarding:
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 America can help you confirm the proper status and classification for your product, ensuring you start the process off right.
2) 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, safety, 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.
3) Technical Documentation
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
- the design verification and validation test reports
- the clinical evaluation
- the labeling
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.
4) Conformity Assessments
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 routes a manufacturer may take to CE Marking. 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.
5) 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.
Advantages
LNE/G-MED is recognized to assess Active Implantable Medical Devices and has significant experience certifying a wide range of devices for CE Marking, often in conjunction with ISO 13485, CMDCAS, third party FDA inspection and other certificates, to save the time and cost of multiple audits.
You also benefit from:
- Local Washington, DC based office with qualified auditors throughout North America to increase convenience and minimize travel costs
- Simultaneous certification for CE Marking, Quality Management Systems (ISO 9001, ISO 13485, ISO 14001) and other standards often performed by a single, highly-qualified auditor, to save you time and expense
- Widely recognized LNE/G-MED expertise as a European Notified Body (CE 0459), as an Accredited Certification Organization by France's accreditation body COFRAC, as a Registrar accredited by the Standards Council of Canada under the Canadian Medical Devices Conformity Assessment System (CMDCAS) and recognized by Health Canada and as a Third Party Accredited Person by the U.S. FDA
- Added services, such as product testing (EMC, electrical, mechanical, CB Scheme), product certification, pre-assessment audits and fast-track or onsite review for CE Marking
Find Out More
LNE/G-MED America offers in-person, online and other customized training on a wide range of certification and quality topics. For details, check out our training schedule or request a customized program.
