UEAPME Position Paper in response to the consultation - UEAPME

Document Sample
UEAPME Position Paper in response to the consultation - UEAPME Powered By Docstoc

PUBLIC CONSULTATION regarding the Proposal for a Directive of the European Parliament and of the Council amending Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
The UEAPME NORMAPME Healthcare Forum welcomes the Commission initiative to consult public on the draft revised Directive 93/42/EEC. The Forum hopes that this consultation is not only a formal act, but in integral part of the drafting process that serves to identify concerns and adjust the draft text where appropriate. In its reaction to the Commission Communication on medical devices COM(2003) 386 final, the UEAPME NORMAPME Healthcare Forum had already stated that Directive 93/42/EEC is generally functioning satisfactorily. A number of proposals were put forward in areas, where the directive has not provided the expected results. The draft revised directive suggests a number of amendments which the UEAPME NORMAPME Healthcare Forum clearly welcomes:  The deletion of article 1 (6) clearly finds our support. Especially ear moulds produced by hearing aid manufacturers for ear and noise protection serve as disease prevention. At the same time, they serve as a means of relief for handicaps in the sense of article 1. By removing article 1 (6), current uncertainties could be overcome.  It is also appreciated that the draft revised directive facilitates the use of modern IT tools and integrates new market and technological developments. In particular the inclusion of software in the definition of medical devices under article 1 takes account of ongoing developments. Manufacturers of custom-made devices are also increasingly using software to recognise or supervise special handicaps. Electronic audio tests are just one example. On the other hand, the draft revised directive fails to respond to several serious concerns raised by the manufacturers of custom-made devices on numerous occasions, including the meetings of the Medical Devices Expert Group.


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 therefore wishes to reiterate these concerns as part of this public consultation.

Surveillance of custom-made devices manufacturers
The situation according to directive 93/42/EC:  According to directive 93/42/EC, custom-made medical devices (CMD: dental prostheses, spectacles, orthopaedic footwear, orthopaedic prostheses, audioprostheses etc.) are class I and class II products, but are only subject to a declaration of conformity from the manufacturer (art. 11). CE marking is not required (art. 17).  While compliance of all other medical devices is checked by notified bodies, a derogation applies to CMD. In their case, competent authorities should verify the compliance of manufacturers with the Directive’s requirements.  However, practical experience shows an alarming situation. Statistically, a German dental laboratory is only checked by its Competent Authority once every 125 years. Although the figures are somewhat less dramatic for the UK with one check every 25 years, the situation clearly demonstrates the failure of the conformity assessment scheme for CMD. The rigour of the compliance check differs considerably throughout the EU and is non-existent for laboratories outside the EU.  This lack of regular consistent checks leads to a number of dangerous consequences: Product quality: The increasing financial pressure from health insurance systems bears the risk of a shift from quality to the lowest price. The absence of compliance checks facilitates and encourages this development. Patient safety: The increased pressure on prices along with the lack of compliance checks jeopardises patients’ safety. Particular risks arise from the use of cheaper, but more hazardous materials. As regards dental prostheses, hazards arise from devices using alloys, which contain beryllium, nickel, polymers or cadmium. Additional negative effects can be found in the fields of the suitability of CMD for the patient and the durability of the product. Unfair competition: The current system disadvantages the manufacturers who bear the cost of complete compliance with the directive’s requirements. Furthermore, it allows an uncontrolled influx of imports which, in a number of cases2, are known to fail to comply with the legislation. Consequently, tenths of thousands of highly qualified jobs in the EU have already disappeared over the past few years and this process is far from over.
Globudent were found to be bringing in work (dental prostheses) from the Far East and supplying this work to dentists in Germany to be fitted to patients. None of this work had a statement of conformity;

Study carried out by the Danish Dental Federation.


the majority were crowns, which are Class IIa devices. Did any of this work meet the essential requirements of the directive? The patients were not made aware that they had work fitted, manufactured outside the EU without any guarantee of compliance with EU rules. Art. 95 (paragraph 3) of the Treaty states: “The Commission, in its proposals envisaged in paragraph 1 concerning health, safety, environmental protection and consumer protection, will take as a base a high level of protection, taking account in particular of any new

development based on scientific facts. Within their respective powers, the European Parliament and the Council will also seek to achieve this objective.” As regards the surveillance of custom-made devices manufacturers, the Forum believes that the current provisions of directive 93/42/EC do not meet the requirements of Art. 95 of the Treaty. The directive’s revision must be used to improve the situation.

The proposals of the UEAPME NORMAPME Healthcare Forum:  The current system clearly fails to guarantee patient safety in the field of CMD. Therefore, two other options should be examined:  1st option: Improving Surveillance Through Competent Authorities The current system could be enforced by clearly defining the scope of inspection and setting minimum (percentage of manufactures) number of inspections per year. While this could be an acceptable solution as no change of system is required, competent authorities are unlikely to raise the necessary funds to finance more frequent compliance checks (for example: 20 % of manufacturers must be inspected every year).  2nd option: Third party audits Industry has therefore proposed Third Party Audits, which would not involve any additional costs for the Competent Authorities, but still guarantee compliance with the directive. The system would consist of the following elements: (a) Introduce a standard GMP (good manufacturing practice) for all manufacturers of custom-made medical devices. This could be based on a CEN standard mandated by the European Commission. (b) Introduce affordable annual third party inspections of all registered custom-made device manufacturers. Such schemes have already been developed on a voluntary basis in the UK, Norway, Denmark, Belgium, Spain, France, Italy and the Netherlands. (c) Introduce annual inspections of all registered agents placing custom made medical devices on the market. These inspections could be carried out by the notified bodies. (d) All custom made medical devices must have a declaration statement of conformity, which includes name and address of manufacturer a copy of which must be passed to the patient. (e) Make register of custom made manufacturers public. The costs of the system would be entirely borne by industry.



Statement of conformity with Class IIA Custom-Made Devices
In some EU countries, the advice given by Competent Authorities requires manufacturers or agents to pass on the advice to the prescriber and not the final user, the patient. Since CMD are not CE marked, patients are not given any advice about the manufacturer, the CMD, and whether the device meets the essential requirements of the directive. UEAPME has information highlighting the rapid increase in CMD coming from outside the EU. This work is often placed on the market by persons who have not even registered with a Competent Authorities in their country. This has led to the following situation:  Agents are ignoring the MDD believing nobody bothers to enforce it;  EU manufacturers work at an economic disadvantage to non-EU because they have to comply with the relevant directives;  Patient’s health is at risk because materials may be used that don’t meet the essential requirements. The manufacturer himself is the only person who is able to document the manufacturing process (use of CE marked components, instructions for use). No other member of the supply chain is able to provide this, and should therefore no be allowed to issue statements of conformity;  Patients are not provided with any information about their CMD. The proposals of the UEAPME NORMAPME Healthcare Forum:  Since manufacturers and agents must already provide a statement of conformity, it will be easy to supply a patient copy at no extra cost to anybody;  Patients will know the name and address of the manufacturer should there be a problem with the CMD;  The patient will have a detailed description of the device and information relating to its use and storage;  This enables the system of traceability. The patient would be able to find out if the manufacturer or agent was registered with their CA;  If the statement is combined with the invoice patients will know the original cost of the CMD and if the prescriber has added to the cost;  Any non-conformities would be contained in the statement.

EUDAMED Database and Custom-Made Devices
The UEAPME NORMAPME Healthcare Forum has repeatedly invited the European Commission to work towards the inclusion of CMD in the Eudamed database. Article 14 of the draft revised directive is now explicitly excluding CMD. It is regrettable that the Commission and the Eudamed Committee never sought a dialogue with the CMD manufacturers although they are best placed to provide professional input in this matter. 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. As already outlined above, for reasons of health and safety, the patient should be able to verify whether his CMD was made by an authorised manufacturer. If this is not possible and, in addition, he neither receives a statement of conformity nor are CMD manufacturers properly checked, then 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 exemption regarding CMD introduced in art. 14 (4) should be removed.  The Commission should launch a real dialogue with the CMD manufacturers with a view to integrating CMD in Eudamed.

Annex VIII – German version
The German version of annex VIII, point 2.1, forth point, is in contradiction with Article 1 (d) of the directive. This article states: “Die oben genannte Verordnung (for a custom-made device) kann auch von jeder anderen Person ausgestellt werden, die aufgrund ihrer beruflichen Qualifikation dazu befugt ist.“ However, annex VIII, point 2.1, forth point, speaks only of prescriptions made out by medical practitioners (ärztliche Verordnung). Proposals of the UEAPME NORMAPME Healthcare Forum With a view to avoiding ambiguities, the term “ärztliche Verordnung” used in annex VIII should be replaced by the one used in article 1 (d), which is “schriftliche Verordnung”. If this is not possible, the forth point of annex VIII (2.1) should be extended in accordance with article 1 (d): — die spezifischen Merkmale des Produkts, die sich aus der betreffenden ärztlichen Verordnung ergeben. Diese Verordnung kann auch von jeder anderen Person ausgestellt werden, die aufgrund ihrer beruflichen Qualifikation dazu befugt ist.“

Brussels, 20 June 2005