Fabian Demicoli

ATTN: Importers/ Distributors of medical devices

 GRTU received the communication below from the MSA: As national competent authority for the implementation of the EU Directives on medical devices (93/42/EEC, 90/385/EEC and 98/79/EC), the Malta Standards Authority wishes to remind you of your legal obligations when importing medical devices both from within the EU and from outside the EU.

 

The basic (non-exhaustive) legal requirements for each individual medical device placed on the Maltese market are:

Devices must be CE-marked on the outer packaging, instructions leaflet and, where possible, on the product itself. The CE-mark must be in the format required by the Directives;

Devices must display all the information and warnings required by the relevant Directives (e.g. for general medical devices, refer to Annex I section 13 of Directive 93/42/EEC);

All information on the outer packaging, instructions leaflet and on the product itself must be in, at least, the English or Maltese language;

The outer packaging, instructions leaflet and, where possible, the product itself must bear the full name and full address of the original manufacturer and, in cases where the manufacturer is based outside the EU, the full name and full address of his EU authorized representative must also be present. Hence, when importing products manufactured outside the EU, ensure there are 2 addresses present;

In case of products marked as sterile, have a measuring function or present a medium or high risk, the CE-mark must be followed by a 4-digit number which is the identification number of the third-party laboratory authorized by the EU to check compliance of medical devices. You can use the EU Commission's website to check whether a particular laboratory is approved for testing medical devices –http://ec.europa.eu/enterprise/newapproach/nando/index.cfm?fuseaction=notifiedbody.main   

Some medical devices require registration in at least 1 Member State. You are required to ensure the product is registered already in another Member State, otherwise contact us to check whether registration is required;

Ask the manufacturer for a "Declaration of Conformity" before importing devices. The Declaration of Conformity will state which EU Directives and EU standards have been used. These must refer to the Medical Devices Directives mentioned above;

The details on the Declaration of Conformity (including manufacturer's name and address, EU representative's name and address, product name and product traceability numbers) must perfectly match the details on the product and product packaging.

These regulations have been in force in Malta since 2001. No excuses for non-compliance will be accepted and full responsibility for the compliance and safety of medical devices falls exclusively on the economic operators. The fact that a device has been already marketed in Malta or in another EU Member State for several years does not replace the above obligations. The fact that a device has been accepted by users (be it private or Government entities) in the past does not replace the above obligations. The fact that similar products are already on the market does not replace the above obligations.

Failure to adhere to the regulations will not be tolerated. Non-compliant products will be withdrawn from the market, actions will be taken against the economic operator, and all other EU Member States shall be informed so that the product is also withdrawn from their markets.

Should you require any clarifications kindly contact:            Mr. David Pulis, or 23952000

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