Medical Device Directive
The European Union defines medical device broadly, including any instrument, apparatus, appliance or even related software intended for the diagnosis, prevention, monitoring, treatment or alleviation of disease.
Falling under the Medical Device Directive (MDD; 93/42/EEC) are all of those devices not covered by more specific directives for In Vitro Diagnostics (IVD) or Active Implantable Medical Devices (AIMD).
Challenges
The MDD is a complex document which outlines the essential requirements, classification rules and conformity routes for assessment of medical devices. Determining the specifics related to your device requires an understanding of the MDD's 23 articles, dozen annexes and 18 classification rules.
The assessment criteria and requirements depend on the complexity of the device, so manufacturers must determine whether their device is covered by the MDD or another directive (for example, the Active Implantable Medical Device Directive).
In the case of "borderline" products, which appear to be related to multiple directives, a positive determination is required. And certain products face more stringent requirements to ensure their safety. For example, implantable items must have a quality system that takes into account concerns of biocompatibility and sterility.
Trust the certification of your medical devices to a Notified Body with the authority and expertise to properly assess a wide range of devices, so you can ensure a reliable assessment that stands up to regulatory scrutiny.
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.
