Medical devices are an integral part of the modern healthcare. No medical task is possible without them; be it diagnosis or treatment. There is a wide range of medical devices, from the thermometer, medical glove to high technology implants, monitoring, etc.
Medical device industry works on strong regulatory policies. Forna medical device to be able to circulate in the European market, a medical device must comply with the regulatory approval, i.e., it must bear a CE Mark.
What is a CE Mark?
The CE-mark indicates devices compliance with EU legislation and thus, implicates that they meet EU safety, health, and environmental protection requirements.
CE-mark is obligatory for medical devices placed on the European Union single market. The medical device bearing CE mark is considered safe for application in clinical practice with sufficiently proven performance.
What are the requirements for CE Marking?
The process of obtaining a CE-mark, considering the non-transparency in the process and varying requirements of different types of medical devices is often deemed as a complicated, expensive and cumbersome procedure. But with proper guidance and understanding of the elements to meet the compliance, you can easily obtain CE mark for your medical device.
Keep into account the following essential steps for obtaining the CE Mark.
- CLASSIFY AND IDENTIFY :
The manufacturer will have first to know under which category the medical device falls? It is necessary to define the characteristics of the medical device like how does it function? What is its purpose? You can follow the rules for classification available on the official website of CE Marking. The manufacturer will have to ensure that the device adheres to all the regulations laid down by the EU derivatives and legislation.
The manufacturer also has to end the medical device is compliant with all the standards and health and safety requirement listed by the European Harmonized Standard.
- GATHER TECHNICAL DOCUMENTS:
The manufacturer has to compile the necessary technical documentation like medical device tests, assessments, product inspections and relevant audits. All medical devices of all classes require a Technical File which is proof of compliance with applicable directives.
- EUROPEAN AUTHORIZED REPRESENTATIVE:
If you are a manufacturer of a medical device that does not have a registered address in the European Union, you will have to appoint a European authorized representative, to seek a CE mark.
Depending upon the device classification, if its class I product, a manufacturer can self-certify the product and if it belongs to an upper-class category, a notified body will be required to inspect technical documents.
After acquiring the certification, the manufacturer should get the CE marking affixed clearly along with the EAR’s details, on both the device and the packaging.
- COMPLYING WITH NATIONAL REQUIREMENT:
By registering their medical device with the National Competent Authorities, your device can now be introduced to the several EU companies.
Keep these crucial points into consideration to obtain CE Mark for your medical device, without any complication. If you wish to let instead a legal firm manage it for you or help you with the technical documentation, identification, you can reach out to reputed law firms online that will help you by giving adept business legal advice encompassing every domain be it: medical, alternative dispute resolution, intellectual property etc without any unexpected billings.
Published by Evie Mills