Medical Device Marketing
Your medical device marketing for Europe has new rules in 2010. You have come to the right place for help with your certification of medical device. The new medical directive requires additional proof that your device is safe.
Regulatory Affairs Associates (RAA) http://www.regaffairs.net/ is a team of highly experienced experts that can deliver results for you. Certification is our game. We have over 35 years of experience in this dynamic process that has delivered quality results for large and small clients.
We know how to make sense of the legal jargon and the alphabet soup of global rules and regulations.
Our mission is to:
- Get the approval
- Maintain the approval
- Expand the approval
- Restore the approval
The following link takes you to the text of the directive as published by the Council of the European Communities. It includes all the definitions of medical devices and the articles governing those devices. http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CELEX:31993L0042:EN:HTML
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The Medical Device Directive has been in place since June 14, 1993. It was amended on September 5, 2007. The consolidated directive became mandatory on March 21, 2010. This directive establishes essential requirements and standards for the manufacture, design and packaging of medical devices. [dlt1]
Medical device marketing falls into three classes.
- Class I devices are low risk, such as stethoscopes, and wheelchairs. Manufacturers of sterile (Class Is)products and devices with a measuring function (Class Im) must apply to a Notified Body for certification of the aspects of manufacture relating to sterility or metrology.
- Class IIa are low-medium risk devices, such as hearing aids, and ultrasonic diagnostic equipment. They require a conformity assessment according to an audit of the full quality assurance system or an audit of final inspection and testing.
- Class IIb are medium-high risk devices, such as surgical lasers and ventilators. It requires a Type Examination of the product except for the full quality assurance route.
- Class III devices are high risk, such as balloon catheters and prosthetic heart valves. Routes to compliance are audit of the full quality assurance system and Type Examination of the product or audit of the production quality assurance system.
For all classes you must prepare a “Technical File.” It should demonstrate compliance of the device with the directive’s essential requirements. Products shipped must bear the CE marking to show compliance with the directive.
“The biggest change in the directive is in the area of clinical evaluations.” All devices now require these data, including Class I devices. Also, this imposes more stringent requirements as to what constitutes "clinical evidence" and mandates stronger enforcement by authorities. Annex X on Clinical Evaluations has been significantly amended. The new medical directive specifically defines what clinical data is and what companies must do to ensure the safety, and demonstrate the performance of the medical device. In the past, citation of other similar products’ clinical data was sufficient for the CE Marking application. In 2010, this literature comparison will require exact device comparisons. Your company may have to perform more clinical investigations to qualify for certification.
Another change is the definition of a medical device. For the first time, software will now be considered an active medical device, whether integral with the device or as a stand-alone product. Software engineers will need to have their products CE Marked before release in Europe.
The classification system has also changed. Some devices that are currently lower risk devices under the new medical directive will be considered Class III, high-risk devices. Your product may need a design dossier[dlt2] .
A major change in the medical directive requires companies to conduct sustained and coordinated clinical post market surveillance of their products. The rules have tightened. You will now need to proactively monitor how your device is being used and performing in the field. There is significantly more emphasis on your post-market clinical follow-up[dlt3] .
Your medical devices may need recertification. 2010 is the beginning of these changes. Please consider contacting us to help you with your medical device marketing.. Our company is ahead of the curve and ready to help you with your CE Marking applications.
Written by: Margaret Stenerson
9 28 2010
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