Combination Products. CE Mark medical device, certification ISO 13485, AIMD, Canadian medical device regulations

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Combination Products

Although the notion of Combination Products under U.S regulations can be broad, the EU medical directives cover essentially three configurations:

Medical device incorporating a drug
Medical device incorporating a human blood derivative
Medical device using a material of animal origin

According to one survey, an estimated 30% of products under development are such "combo" products. The convergence of drugs/biologics and devices brings a host of regulatory challenges.*

Challenges

Combination products are Class III devices which require a thorough assessment procedure. Because of their complexity and risk, not all Notified Bodies can assess combination products, which may be subject to additional directives if devices incorporate a substance of animal origin (if considered a risk of transmissible spongiform encephalopathies) or human blood derivatives.

Determining a device's status, whether it is a drug or medical device, depends upon its primary mode of action. This can be a difficult determination involving not just the Notified Body, but also the Competent Authority and the European Commission.

Your selection of a credible, respected Notified Body is critical, so that you can have confidence in their assessments and collaboration with other organizations. LNE/G-MED has significant experience with various families of combination products and can call on experts in biological and viral safety when necessary to certify products.

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.

Contact LNE/G-MED America

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