Introducing Medical Device in Europe
Do you have a product ready for deployment in the European market? Every company or entity that trades medical equipment in the European market is required to obtain a CE-mark. CE-Mark is proof that your equipment conforms with all legal requirements of the European market. As the responsible party, you must comply with the set of requirements and processes known as The Medical Device Regulation (EU) 2017/745. The Medical Device Regulation (EU) 2017/745 will set the requirements needed to obtain the CE-Mark, after which you can introduce your medical equipment to the European market.
Classification – Medical Equipment:
The most important part before getting certified is to understand whether your product can classify as a medical device. This step serves as the basis for conformity. Medical devices can range from a simple syringe to body implants, and all of them are included in Medical Device Regulation. The devices are divided into three risk classes: Class I, Class IIa, Class IIb, and Class III. The risk class of your product depends on its characteristics. Class I represents a low risk, Class II represents a moderate risk, and Class III represents a high risk.
Access the EU Market: Our Assistance:
Your medical device and its documentation need to comply with the EU Medical Device Directive. Every case is unique and requires an approach according to its attributes.
We will verify your medical device will meet all mandatory requirements by offering a certification support process that is quick and customized according to your needs. If you are unsure whether your product can classify as a medical device, we can provide a confirmation service. We will handle everything after you provide specific information about your product and guarantee that your medical device complies with the requirements.
7 Steps to Reach Compliance to EU MDR
Is classification changed for the device? We will review and help you confirm the proper classification.
Is conformity route changed? What is the right one for your case?
Find Notified Body/ Do you need to find or switch NB?. We have contact and liason to most renewed and efficient Notified Bodies.
Prepare technical file as per Annex II MDR.
Is Clinical Evaluation still compliant (MEDDEV 2.7.1 rev 4)?
Review and make sure your QMS is compliant to Art. 10 (9) and ISO 13485:2016. Reach out to ask support
Apply udi and get ready for eudamed. Reach out to ask support
Prepare PMS processes and documentation according to Annex III MDR.