DearSir/Madam,
Please find belowthe contribution of the Medical Device Industry, represented by COCIR, EDMA and EUCOMED, to the EU Commission review of Directive 2002/95/EC on the Restriction of Hazardous Substances in Electrical and Electronic Equipmentas well as the Joint Medical Industry Comments on the ERA Final Report, in attachment.
Medical Device Industry Contribution to the EU Commission review of Directive 2002/95/EC on the Restriction of Hazardous Substances in Electrical and Electronic Equipment
The European Trade Associations shown above, representingapproximately 90% of the EU Medical Device Industry, welcome the opportunity to comment as part of the European Commission’s ‘Invitation for Comments on Topics and the Supply of Information’ in support of the European Commission Article 6 review of Directive 2002/95/EC (RoHS).
COCIR, EDMA and EUCOMED fully support the ERA report number 2006-0383 ‘Review of Directive 2002/95/EC (RoHS) Categories 8 and 9’ dated July 2006, as prepared by Dr Paul Goodman of ERA. For more details, refer to the document titled ‘Comments on the ERA report’ dated Oct 31 2006. Although Dr Goodman’s report covered Category 8 and 9 devices, the medical industry associations can only comment on how the review will impact medical devices that are Category 8 products.
In summary the key differences of Category 8 products compared to other electronic products are that:
1. Medical devices improve public health and are life-enhancing and life-supporting;
2. Medical device designs and products can have a long life expectancy;
3. Some substances classified as ‘hazardous substances’ are essential for the technical function of some medical products (e.g. electrodes, x-ray shielding, transducers and sensors). Lead, in particular, provides the solder joint integrity and stability critical to printed circuit assembly performance needed to meet the reliability requirements of medical devices.
Although medical devices are currently exempt from the RoHS Directive, the medical device manufacturers represented in our associations are being impacted to a lesser or greater extent. Some larger manufacturers (primarily of low-risk medical devices) are exploring lead-free manufacturing because they do not wish to run two different production lines and they are having increasing difficulty obtaining non-RoHS compliant components.
Supply issues identified so far include but are not limited to:
1. Medical Devices are being made obsolete prematurely due to the difficulty in obtaining off-the-shelf parts. (Low usage parts are not being converted to ‘hazardous substance free’ versions. This is focusing engineering resources away from next generation designs and delaying the introduction of more beneficial diagnostic methodologies);
2. Component suppliers are withdrawing non-RoHS compliant parts from the market due to low volume as non Category 8 & 9 manufacturers switch to RoHS compliant components (this may necessitate ‘life time’ buys) with associated risks of component deterioration and storage costs. Even though this increases control complexity and cost, these are preferable to the substantial costs associated with product redesign.
3. There is generally poor differentiation by component suppliers between compliant and non-compliant components - thus is causing declaration, manufacturing process and spare part/repair difficulties. Consideration needs to be given to ensuring appropriate declaration of component RoHS status by component manufacturers/suppliers;
4. RoHS compliant parts from some suppliers do not always have the same form, fit and function as the original non-RoHS parts. This makes it very difficult to evaluate and ultimately integrate these parts into existing products;
5. Compliant components are more expensive (up to 20%). This is being absorbed by the manufacturer in the short term but inevitably will have to be absorbed by the customer in the long term, potentially resulting in higher healthcare costs;
6. Development costs to migrate to RoHS-compliant parts are significantly higher due to additional reliability testing, manufacturing testing, re-qualification of staff, additional personnel, capital equipment upgrading etc;
7. The industry would like to see greater consideration of international standards (e.g. IEC 60601-1-9, Medical electrical equipment - Part 1-9: General requirements for basic safety and essential performance - Collateral Standard: Requirements for environmentally conscious design) to reduce environmental impacts. This is also suggested in Dr Goodman’s report (12.2, page 229).
Manufacturers who have undertaken lead-free production report that:
1. They are not able to determine reliability with sufficient accuracy, which raises uncertainty as to whether manufacturers who adopt lead-free soldering techniques are compromising their legal CE marking of medical devices to Directive 93/42/EEC concerning medical devices. (There have already been cases of ‘whiskering’ and tin whiskers are a source of risk that is difficult to prevent and control because tin whiskers are not detectable until long after the product has been manufactured and shipped to the clinical user.);
2. Conversion to RoHS compliance invariably uncovers reliability problems that take time and resources to solve. To-date, this presents two critical issues: (1) there are no field data on reliability performance of RoHS compliant products; and (2) there are no proven solutions for those problems that have been identified thus far through research;
3. For leadless (pronounced “leed-less”) components such as Ball-Grid Arrays, Chip Scale Packages and Wafer level Chip Scale Packages, the lead (Pb) substitute, commonly know as the SAC (SnAgCu) alloy has poor solder joint integrity and electro-mechanical robustness. Balled-Grid components present a very serious reliability risk for medical products.
In addition to manufacturing and support issues, the medical device industry has identified some potential trade consequences. These are important as medical device manufacturers typically have low volume production and have to think globally in order to justify development:
1. There are an increasing number of barriers to trade between EU companies and non-EU countries. The adoption of similar, but not identical, legislation outside of the EU will necessitate production of market specific versions of medical devices;
2. There is a possibility of a competitive disadvantage if EU companies have to sell (more expensive, RoHS compliant) devices into non EU-markets in competition with non-RoHS compliant devices.
Our associations and their members fully support the aims and objectives of the RoHS Directive, but would appreciate the ability to be able to use the substances controlled by the RoHS Directive where it can be shown this is justified on the basis of a risk analysis. With the current state of knowledge, the use of RoHS substances in critical applications of medical devices is necessary to minimize the risk of product failure and recalls.
The inclusion of Medical Equipment under the RoHS Directive should be subject to the reliability of lead free technology under field conditions being assured based on the ongoing studies.
Our associations and their members would welcome the opportunity to further discuss any of these matters in person with the appropriate representatives of the European Commission. Please let us know when such meeting would be possible.
With our best regards,
Freimut Schröder, Karen Howes, Maurice Wagner,
COCIR EDMA Eucomed
(1) COCIR, The European Committee for the Radiological, Electromedical and Healthcare IT Industry, is the European Trade Association representing leading companies and national trade associations in these fields. COCIR supports the development of new and innovative technologies and their access to patients worldwide. COCIR and its members is actively participation in European and International initiatives promoting global harmonisation.
(2) EDMA, the European Diagnostic Manufacturers Association is the trade association that represents the In Vitro Diagnostic (IVD) industry active in Europe. EDMA membership brings together 20 National Associations in European countries and 29 of the major companies engaged in the research, development, manufacture or distribution of IVD products. Through its affiliated National Associations, EDMA represents in total more than 500 companies (or over 700 legal entities) across Europe.
(3) Eucomed is the Voice of the medical technology industry in Europe. Eucomed represents directly and indirectly 4500 designers, manufacturers and suppliers of medical technology used in the diagnosis, prevention, treatment and amelioration of disease and disability. Small and medium sized companies make up more than 80% of this sector. The European medical technology industry invests some €3,7 billion in R&D and employs near to 435.000 highly skilled workers. The mission of Eucomed is to improve patient and clinician access to modern, innovative and reliable medical technology.
Please do not hesitate to contact us should you have any questions.
Best regards,
Cristian Manoiu
Project Coordinator
Place des Maïeurs 2 - 1150 Brussels
Tel: +32(0)2.761.22.80
Eucomed is the Voice of the medical technology industry in Europe. Eucomed represents directly and indirectly 4500 designers, manufacturers and suppliers of medical technology used in the diagnosis, prevention, treatment and amelioration of disease and disability. Small and medium sized companies make up more than 80% of this sector. The European medical technology industry invests some €3,7 billion in R&D and employs near to 435.000 highly skilled workers. The mission of Eucomed is to improve patient and clinician access to modern, innovative and reliable medical technology.
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