Clinical Evaluation as per MEDDEV 2.7.1 Rev 4 Latest requirement to fulfill MDD compliance for Medical Device Manufactures!!! Clinical Evaluation Reports (CERs) Preparing a clinical evaluation report (CER) is time consuming and always need the support of skilled consultants. A post-market surveillance plan for each medical device or device family that specifies the frequency of performing a review and update of your clinical evaluation report (CER). What are included in Clinical Evaluation Report? Published […]
A Competent Authority is the body, which has the authority to act on behalf of the government of a member state to ensure that the requirements of the Medical Devices CE Marking directives are carried out in that particular member state. The European Union (EU) comprises 28 member states. Each member state is party to the founding treaties of the union and thereby subject to the privileges and obligations of membership. Notified Body is a […]
Is CE MARKING valid ACROSS the world market? No. CE marking is required for the European market only. It is valid in all 32 countries of the European Economic Area. But its sure without any doubt, CE marking make it easier to obtain access to other markets, such as Australia, India, Middle East Countries, Turkey.