Directives 90/385/EEC, 93/42/EEC and 98/79/EC on medical devices stipulate that regulatory data collected in accordance with the Directives should be stored in a European database accessible to competent authorities. In particular, the database should contain the following:
data relating to registration of manufacturers and authorised representatives and devices, excluding data related to custom-made devices;
data relating to Notified Body certificates issued or modified;
data obtained in accordance with the vigilance procedure for incidents;
data relating to clinical investigations.
Such a databank has been developed by the European Commission in cooperation with the Member States under the name ‘European Databank for Medical Devices (Eudamed)' and is already being used by numerous Member States on a voluntary basis.
As concerns data existing collected by Member States before 1st May 2011, Member States shall only need to input data on registration of manufacturers, authorised representatives and devices into Eudamed. This Decision shall apply as from 1st May 2011.
The aim of Eudamed is to strengthen and facilitate market surveillance by providing competent authorities with fast access to information on medical devices, as well as to contribute to a uniform application of the regulations, in particular in relation to registration requirements.
The only expected impacts are the following:
Thanks to such rapid communication channels between market surveillance authorities, the risk for patients of a safety incident or malfunctioning will be reduced. In particular, rapidly sharing information on any known incidents will diminish the risk of recurring incidents elsewhere in the EU.
A change in administration and data inputting procedures is required at the national Competent Authority level.
When registering medical devices with the Competent Authority, manufacturers or importers will now be required to give their postcode, phone or email, and an internationally recognized nomenclature code for their devices, in addition to the already requested information. This shall not apply to registration of custom-made devices.
Such internationally recognised nomenclature for medical devices is necessary to allow a uniform description of the devices concerned and efficient use of that databank. Given that data can be entered in all official languages of the Community, a numeric code should be used so that devices can be easily searched. The Global Medical Device Nomenclature is such an internationally recognised nomenclature, but it is not the only option that can be used. Such nomenclatures are normally obtained at a cost from private agencies.
Who will be effected?
Competent Authorities, Manufacturers, Authorised Representatives, Notified Bodies and Importers of Medical Devices.
Any feedback on the Decision would be appreciated by 4th June 2010. Should you require any further information please do not hesitate to contact Mr. David Pulis at MSA on E: T: 2395 2000
The SME Chamber is your best business partner while you are in business. It is your first port of call for any issues related to your business. In addition the SME Chamber also updates you with the information that is most relevant to your business to ensure you do not waste time trying to catch up and do not miss any important information.
A membership with one of Malta’s largest business representative and the oldest registered national employer representatives and recognised social partner at law offers several advantages such as a representation at national level and EU level, a One Stop Shop for Businesses, Assistance with several applications, information sessions, masterclasses & conferences, networking events, free legal advice, identifying funding and schemes, expertise on local issues & legislation and employment support amongst several others.
The Malta Chamber of SMEs presently represents close to 7,000 businesses. As the oldest registered national employer representatives and recognised social partner at law, we are consulted on various legislation changes and represent businesses in local and EU issues.
A core value that is generated by networking events is social value which involves meeting with people at events to create and/consolidate various types of relations. For Businesses this is crucial and the SME Chamber throughout the year organises several networking opportunities which includes conferences, meetings, business breakfasts and lunches.
Funds and incentives are available for all businesses and the Malta Chamber of SMEs can help in finding those that are right for your business. These include grants to buy equipment and machinery and make upgrades in your business, tax credits, assistance on employment and training for employees, maternity trust fund and much more.
In order to stay competitive business owners and your employees need to update their skills, the SME Chamber tailor-makes courses, webinars, masterclasses and other information sessions for the needs of its members on topics such as health and safety, new legislations, access to finance, digitisation, amongst others.
BECOME A MEMBER
The Malta Chamber of SMEs represents over 7,000 members from over 90 different sectors which in their majority are either small or medium sized companies, and such issues like the one we're experiencing right now, it's important to be united. Malta Chamber of SMEs offers a number of different services tailored to its members' individual requirements' and necessities. These range from general services offered to all members to more individual & bespoke services catered for specific requirements.
A membership with Malta Chamber of SMEs will guarantee that you are constantly updated and informed with different opportunities which will directly benefit your business and help you grow. It also entails you to a number of services which in their majority are free of charge and offered exclusively to its members (in their majority all free of charge).
Strictly Necessary Cookies
Strictly Necessary Cookie should be enabled at all times so that we can save your preferences for cookie settings.
If you disable this cookie, we will not be able to save your preferences. This means that every time you visit this website you will need to enable or disable cookies again.