How do you know if a standard is harmonized?
You can find a list of harmonised standards on the EU official website. Importers and manufacturers should first determine which directives and regulations cover their products, and then look for relevant harmonised standards.
How do I get an EC declaration of conformity?
How to draw up a declaration of conformity
- your name and full business address or that of your authorised representative.
- the product’s serial number, model or type identification.
- a statement, stating you take full responsibility.
- means of identification of product allowing traceability – this can include an image.
What is meant by harmonized standards?
Harmonized Standards means technical specifications meeting the essential requirements of the EU directives, compliance with which will provide a presumption of conformity with the essential requirements for the Licensed Product.
Is ISO 14971 harmonized?
Regulatory requirements for risk management EN ISO 14971:2012 is harmonized to the European Medical Device Directives (AIMDD, IVDD and MDD), which allows presumption of conformity to the Directives.
What is EC Conformity certificate?
A EU Declaration of Conformity (also called a CE Certificate, EC Declaration of Conformity, or CE Declaration of Conformity) is the document confirming that the product complies with the applicable CE marking directives or regulations.
What is the difference between EC and CE?
It is a EC declaration of conformity. A CE declaration does not exist formally. However, a product consists of the product itself, a User manual and an EC declaration of conformity. In general, the EC declaration of conformity is also called a CE Statement or CE certificate.
What is harmonization process?
Process harmonization is the activity of designing and implementing business process standards across different regions or units, so as to facilitate achieving the targeted business benefits arising out of standardization, while ensuring a harmonious acceptance of the new processes by the different stakeholders ( …
What is a harmonised standard?
A harmonised standard is a European standard developed by a recognised European Standards Organisation: CEN, CENELEC, or ETSI. It is created following a request from the European Commission to one of these
What are the harmonised standards for machinery safety?
The harmonised standards for machinery consists of three types of product safety standards. A-type standards specify basic concepts, design principles and terminology that apply to all different categories of machinery.
Where can I find information on harmonised European standards for medical devices?
It is available in the “ Standardisation – Mandates ” database as M/575 ( EN version Search for available translations of the preceding link EN ••• – FR and DE available, clicking on the linguistic icon). The first publications of references of harmonised European standards under the medical devices regulations are available:
What are the harmonised standards published in the OJEU?
References of harmonised standards and of other European standards published in the OJEU 1 Cosmetics products 2 General product safety 3 Personal protective equipment (PPE) 4 Toys safety