Frequently Asked Questions

FAQsAs a service to our clients and other industry professionals, LNE/G-MED America has compiled questions our technical staff are often asked regarding our services, CE marking of medical devices and other regulatory issues.

We regularly answer new questions, so check back often. Submit your own questions using our Ask Our Experts form and we'll respond personally.

Most Recent Questions

In terms of CE Marking a medical device, what directives are concerned?
Three specific directives relate to CE marking for medical devices:

  • 90/385/EEC active implantable medical devices
  • 93/42/EEC medical devices
  • 98/79/EC in vitro diagnostic medical devices

Depending on the specifics of your product, other specific directives could apply, such as those related to electromagnetic compatibility or those covering substances which are delivered by your device.

Are the rules for selling a medical device in Europe the same in all European countries?
Yes. The “new approach” Directives 90/385/EEC, 93/42/EEC and 98/79/EC provide a common legislative base for all European countries (European Union and European Free Trade Association). However, we recommend that you consult the national law from which the Directives were adapted (e.g., the Public Health Code in the case of France).

Is CE Marking valid for the world market?
CE Marking is a requirement in more than 30 countries, including all of those in the European Economic Area (EU plus EFTA). While not required in other markets, CE Marking may make it easier to obtain access to other markets, such as Australia, Egypt, Morocco or Turkey.

Where can I find the MEDDEV classification guides and the list of harmonized European standards?
These guides are available for download on the European Commission website.

How soon after our audit will be receive the audit report and certification?
Your auditor will leave a copy of the report (draft) at your site after the closing meeting. Although the timing depends on your audit results and how soon you address any issues, the notification of committee decision/issuance of certificate is approximately 8 weeks after the audit. LNE/G-MED offers a Fast-Track review process for CE Marking and works closely with manufacturers on the necessary planning to meet business deadlines.

For answers to your technical questions, use the Ask Our Experts form and we'll respond to you personally.

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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