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CE MARKING New Approach Directives New Approach Directives set out the essential requirements for products to be sold in the European Community. The New Approach Directives apply only when the products are placed on the Community market for the first time and to new and second-hand products imported from third countries. The Directives set the essential requirements for the products and European harmonised standards provide the detailed technical information enabling the manufacturer to meet these requirements. Standards are voluntary, however products conforming to harmonized European Standards enjoy a presumption of conformity with the essential requirements of the applicable Directives. New Approach Directives have been transposed to Maltese Regulations by the Malta Standards Authority.
Affixing of the CE marking to a product is a declaration by the manufacturer that the product has been designed and manufactured to meet all the essential requirements of the applicable EU Directives. The CE mark on a product symbolises safety and is mandatory for products subject to it. These products can be sold anywhere in the Community/EEA, therefore enhancing the single market by promoting free trade and harmonization of rules amongst the Member States of the EU.
Products sold in the Community market must have a proper level of safety. Market surveillance is a necessary tool for ensuring that this goal is satisfied. Member States must establish authorise to carry out such surveillance. The Market Surveillance Directorate is responsible for products on sale locally.
Further information regarding the above principles consult the Guide to the implementation of directives based on the New Approach and the Global Approach and the following link regarding the Market Surveillance Directorate: http://mfea.gov.mt/policy/about_msd.htm Medical Devices Registration CIG201 - Medical Devices Registration Form (.doc) CIG202
- In Vitro Diagnostic
Medical Devices Registration Form (.doc) Vigilance The Medical Devices Regulations include requirements for medical devices manufacturers to report certain types of incidents to the Competent Authority. The Consumer and Industrial Goods Directorate (CIGD) of the MSA is the Competent Authority for Malta for medical devices. The CIGD has the responsibility to institute and co-ordinate a reporting system known as the Vigilance System for adverse incidents associated with the use of medical devices and to share reported incidents with the other competent authorities and the European Commission. The aim of this system is to safeguard the health and safety of patients, users and others by reducing the likelihood of the re-occurrence of the same incidents. All data held by the CIGD in relation to vigilance is held in confidence. Manufacturers have the responsibility by law to report all serious incidents to the Competent Authority on whose territory the incident occurred. There is currently no mandatory reporting system for users, however reporting of serious incidents by the user is encouraged. Users should also inform the manufacturer of the incident and that the user has reported the incident to the competent authority. Further information on the Vigilance System can be found in the European Commission’s official guidelines:MEDDEV 2.12-1 rev 4 CIG001 - Medical Device Adverse Incident User Report Form CIG002 - Initial Vigilance Report Form CIG003 - Final Vigilance Report Form CIG004
- Recall Notification
Form Back to Part 1>> Publications CIG-G-201 - Guidance Notes for the Registration of Persons Responsible for Placing Medical Devices on the Market (.pdf)
Contents
will be available soon
Construction Products Click here to download a list of construction products for which CE marking is mandatory. Lifts
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