CE Marking of Medical Device: Access to Europe

Before you can offer your products to any of the 31 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. Download our free guide on CE Marking of Medical Devices

Challenges

Achieving CE Marking for medical devices requires serious commitment and planning. An essential step includes obtaining the services of a Notified Body, an assessment organization designated by the Competent Authority of an EU member country, to verify that your organization complies with the relevant directives.

Partnering with an experienced and recognized Notified Body, such as LNE/G-MED, can be one of your most important steps to ensure a smooth audit and efficient review of your design dossier or technical files. Our team of technical experts, certification project managers and auditors work closely with you throughout the process so you can benefit from valuable feedback on your quality processes and convey credibility to your customers, business partners and regulators.

EU Directives by Device Type

LNE/G-MED America has the necessary expertise and experience on a wide variety of medical devices and the relevant directives:

LNE/G-MED America can educate you on available paths to certification and  verify which of these directives, or others, apply to your device.

Additional Guidance on CE Marking

As your partner, LNE/G-MED America is committed to your knowledge of the regulations and considerations for offering your products in Europe. Please review the following free documents for additional information:

Advantages

LNE/G-MED America has the necessary expertise and experience working with manufacturers in obtaining 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.

 

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