Healthcare forum /
COMMENTS of the UEAPME NORMAPME
HEALTHCARE FORUM
regarding the
PRELIMINARY DRAFT COMMISSION DECISION
on a European Database on Medical Devices (Eudamed)
The UEAPME NORMAPME Healthcare Forum brings together European representatives from almost 100,000 manufacturers of custom-made medical devices (CMMD) from all EU Member States and beyond. The overwhelming majority of these manufacturers are small enterprises.
The UEAPME NORMAPME Healthcare Forum wishes to comment on the provisions regarding custom-made devices.
Recital 6 states that "more preparation work is needed before custom made devices can be incorporated in the database."
Article 3 stipulates that "Member States shall ensure that the data …, with the exception of data for custom-made devices … is entered into Eudamed using the format referred to in the Annex.
We strongly oppose to the explicit exclusion of custom-made devices (CMD) from Eudamed without any clear reasons.
Lack of political goodwill
Already in our position regarding the revision of the Medical Devices Directive (dated 20 November 2002) we had provided a number of arguments as to why Eudamed should include CMD. Astonishingly enough, the European Commission never reacted on this position paper nor did it inform the CMD manufacturers why "more preparation work is needed". It is also regrettable that also the Eudamed Committee never sought a dialogue with the CMD manufacturers although they are best placed to provide professional input in this matter. It would be interesting to know the reasons for this behaviour.
Most CMD's are made by SMEs. The exemption from the database would thus clearly discriminate against small manufacturers.
Workable solutions for CMD already available
We insist on the fact that databases based on harmonised nomenclatures for CMD already exist and could be easily used for a European system. As a matter of example, Italy is using such a database including all CMD manufacturers and types of CMD manufactured. This document is published and can also be consulted on the internet by all interested parties.
Sweden has also introduced a system including CMD.
INTERBOR - the International Association of Orthotists and Prosthetists - has developed a complete nomenclature on the basis of all relevant ISO and CEN standards and WHO guidelines. This nomenclature could thus easily be adjusted to the Global Medical Device Nomenclature.
Why is the exclusion of CMD dangerous?
The CMD market is a multibillion Euro market. Most devices are used over a very long period of time. Dental prostheses, for example, are permanently fitted within the oral cavity, some are implanted into teeth and bone and may be in use for a lifetime.
A steadily increasing part of this work is being sources from outside the EU. There is little or NO surveillance carried out on CMD manufacturers within the European Union or on agents placing such devices on the market. Many of them are not even registered with a Competent Authority. Hence, nobody knows, whether these devices meet the essential requirements of Directive 93/42 EEC. Consumers have no possibility to know whether the manufacturer is authorised to put CMD on the market.
In this context, the Directive's basic objective to ensure consumer and patient protection, becomes an empty phrase. To exempt such a large part of devices from the database means that political decision makers accept to potentially putting the consumer at risk.
In the light of these arguments we invite the Medical Device Export Group to reconsider the Eudamed proposal and to ensure that the Eudamed Committee closely co-operates with the competent CMD manufacturers' associations to develop a workable European solution.
Proposals of the UEAPME NORMAPME Healthcare Forum
The PRELIMINARY DRAFT COMMISSION DECISION on a European Database on Medical Devices (Eudamed) should be modified as follows:
Recital (6)
Old:Whereas more preparation work is needed before custom made devices can be incorporated in the database, / New:
Whereas the European Commission will closely co-operate with the relevant stakeholders so as to ensure that custom-made devices can be incorporated in the database within the shortest possible period of time.
Recital (11)
Old:Whereas the database is accessible to the Member State competent authorities, whereas manufacturers and notified bodies should nevertheless have access to the data they provided, and competent authorities may consider providing data from the database that is already currently publicly available to interested parties, / New:
Whereas the database is accessible to the Member State competent authorities, whereas manufacturers and notified bodies should nevertheless have access to the data they provided, and competent authorities shall provide certain data with particular relevance to the patient from the database to interested parties,
Article 3:
Old:Member States shall ensure that the data referred to in Article 14 a (a), (b) and (c) of Directive 93/42/EEC, with the exception of data for custom-made devices as defined in Article 1, 2 (d) of Directive 93/42/EEC, is entered into Eudamed using the format referred to in the Annex. To this end, Member States shall ensure that notified bodies submit data relating to certificates issued, modified, supplemented, suspended, withdrawn or refused to the Member State in a format that supports data entry into Eudamed. / New:
Member States shall ensure that the data referred to in Article 14 a (a), (b) and (c) of Directive 93/42/EEC as defined in Article 1, 2 (d) of Directive 93/42/EEC, is entered into Eudamed using the format referred to in the Annex. To this end, Member States shall ensure that notified bodies submit data relating to certificates issued, modified, supplemented, suspended, withdrawn or refused to the Member State in a format that supports data entry into Eudamed.
Custom-made devices are exempted from the database for up to two years counted from the date of entry into force of this Decision. The European Commission, in co-operation with the Competent Authorities and relevant stakeholders, shall undertake to define a workable solution for custom-made devices before that date.
Article 5:
Old:Member States shall ensure that notified bodies and manufacturers have access to data they submitted for inclusion into Eudamed. Member States may, taking due account of Article 19 of Directive 98/79/EC and of Article 20 of Directive 93/42/EC, provide other interested parties with data from Eudamed. / New:
Member States shall ensure that notified bodies and manufacturers have access to data they submitted for inclusion into Eudamed. Member States shall, taking due account of Article 19 of Directive 98/79/EC and of Article 20 of Directive 93/42/EC, provide other interested parties with data from Eudamed.
In particular, patients shall have the right to know whether a manufacturer of medical devices is duly registered.
We hope that our comments will be taken into due account at the MDEG meeting of 30-31 March 2004.
Brussels,