POSITION PAPER THE PROPOSED REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL ON MEDICAL DEVICES. Berlin, 29 April 2013

Transcription

1 POSITION PAPER ON THE PROPOSED REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL ON MEDICAL DEVICES Report of the Rapporteur of the ENVI Committee of 12 April 2013 Berlin, 29 April 2013

2 I. Introduction 1. Vanguard AG is the largest European medical device reprocessor. Vanguard AG undertakes the complete reprocessing of used medical devices and assigns them with a new useful life under substantially equivalent physical conditions that are applicable to the manufacturing of new devices. Vanguard AG has been operating under the German Regulatory System for the Reprocessing of Medical Devices (which covers both Single Use Devices and Multiple Use Devices) since its adoption in Vanguard AG has participated in several scientific studies demonstrating the safety of professional reprocessing. 2. As these studies show professionally reprocessed devices can, and do offer the same standard of safety as new products in terms of their material characteristics and functions. This is supported by extensive field data available both in Europe and in the US (set out in detail in our position paper dated 11 February 2013). Further, in times of unprecedented economic crisis, reprocessing can produce significant cost-savings for healthcare institutions and reduces medical waste. Reprocessing is a means of cutting healthcare costs while maintaining patient safety and quality of care and is an environmentally responsible practice. 3. On 26 September 2012, the European Commission adopted a Proposal for a Regulation of the European Parliament and of the Council on Medical Devices (the Proposed Regulation ). Article 15 of the Proposed Regulation contains rules on the reprocessing of single use devices ( SUD ). 4. Vanguard AG supports the Commission s initiative to introduce regulation to the field of medical devices reprocessing. Howevever as set out in detail in our position paper dated February we believe that two essential areas of the Proposed Regulation drafted by the Comission require amendment. In summary these are the following: Prohibition of Reprocessing of Critical Use Devices: In meeting the requirements of the Proposed Regulation, reprocessors have to demonstrate the same level of safety and protection of the users as original device manufacturers. Therefore prohibiting the reprocessing of critical SUDs until further demonstration of their safety is a disproportionate and excessive measure. Vanguard AG proposes that the ban on the reprocessing of critical SUDs should be replaced with measures that will allow only professional reprocessing, i.e. reprocessing carried out in a controlled environment and in full compliance with safety requirements. National Opt Out Clause: Allowing Member States to prohibit reprocessing services, reprocessed SUDs and exports of used SUDs when they are fully compliant with the Proposed Regulation violates the fundamental freedoms of the internal market and cannot be justified on grounds of protection of public health specific to any Member State, as the Proposed Regulation provides

3 Article 72 of the Proposed Regulation provides for a safeguard clause.thus, further restrictions on the free movement of services and goods as proposed in Article 15 of the Proposed Regulation are manifestly inappropriate and unlawful and should be removed in their entirety. 5. In the report to the ENVI Committee of the EU parliament, dated April , the rapporteur Dagmar Roth Berendt has proposed substantial changes to Article 15 of the proposed regulation. In summary the rapporteur proposes the creation of a European regulatory body which shall determine whether or not a device can be designated as single use. Manufacturers will have to provide evidence to this body that devices cannot be reprocessed before they are permitted to classify a device as single use. Third party reprocessors are entitled to change this designation if they can provide evidence that the device can safely be reprocessed. If the manufacturer proves that the device cannot be reprocessed and a third party cannot provide evidence that a device can be reprocessed, then reprocessing shall not be permitted. Reprocessors are to be held to the same standards as manufacturers. Regulatory standards for reprocessors are to be harmonised and improved by the EU. 6. Vanguard AG supports the objectives of the report to provide a coherent regulatory framework covering both so called single use devices and so called multiple use devices. In particular the proposal for implementing regulation to unify and raise standards of reprocessing across the EU is to be welcomed as this is in our view urgently required in the interest of patient safety. The two fundamental concerns we raised with regard to the Comission proposal ( probibition of reprocessing of critical use devices and national bans ) are addressed by this new proposal. The new proposal however raises some new concerns. Much hinges on the new definition of reprocessable and the regulator being able to determine what is reprocessable and what is not. Otherwise the Proposed Regulation will not be able to effectively curtail the common practice of manufacturers who label products as single use although they can safely be reprocessed by existing technology. In our opinion, as currently drafted, the new proposal would fail to meet this objective and therefore allow manufacturers to effectively continue their practice of mislabeling products as single use, imposing significant unnecessary cost on the healthcare system. However we believe that with some amendments the new Article 15 as proposed by the rapporteur can achieve its objectives and would then represent a real improvement on the Comission proposal and the status quo. The required amendments are set out below

4 II. Proposed Amendments to the New Article 15 proposed by the Report of the Rapporteur 1. In her report to the ENVI Committee of the European Parliament dated April 12, 2013, the rapporteur proposes that the SCENHIR group should carry out the evaluation under Article 15 to determine whether a medical device can be classified as single use. This evaluation is triggered by either a proposal from the original manufacturer or by third parties. In the latter case a positive outcome leads to a reclassification of the device from single use to reprocessable. We believe that the very substantial volume of device dossiers which would need to be reviewed as well as the specific knowledge required in a variety of areas (engineering, biocompatibility, materials analysis, hygiene etc.) to effectively challenge/evaluate manufacturers claims with regard to processability require a level of staffing which is beyond the scope of SCENHIR as currently constituted. A possible alternative would be to coopt member country regulatory experts within the auspices of the European Medicines Agency by establishing a committee for MEDICAL DEVICE REPROCESSING (analogous to the organisations created under EU Pharmaceuticals Law within the European Medicines Agency: e.g. CAT, PRAC, COMP, PDCO, CHMP). In any case the new regulatory agency needs to be adequately staffed/resourced. Otherwise there will be a substantial delay in approving reprocessing procedures at considerable cost to the healthcare system. 2. Article 15 d states that any natural or legal person that reprocesses a device labelled as reusable shall be treated as the manufacturer of that device. This requirement is in line with the proposal made by the Comission in its proposal. We believe that requiring a full conformity assessment for a reprocessor is excessive and economically wasteful. Such an approach would unnecessarily restrict the application of safe reprocessing at significant cost to the healthcare system.the original device has already been subject to a conformity assessment and either the manufacturer or a third party has provided evidence of the product s reprocessability. Therefore a full conformity assessment by the reprocessor would be a duplication of evidence already provided. An alternative would be to require manufacturers to file full product dossiers and allow subsequent filings from reprocessors to reference these dossiers. In the US where current regulation also treats reprocessors as manufacturers, the FDA and Congress have introduced specific modifications to the 510 (k) and the PMA process to strike a balance between holding reprocessors to the high manufacturing standards necessary to ensure the safe and effective reprocessing of SUDs while acknowledging that not every OEM requirement can or should apply to reprocessors. In particular a new type of application was introduced (the Premarket Report PMR ) for Class III devices, which would otherwise have been subject to the PMA requirement

5 The primary distinction between a PMR and a PMA is that a PMR is not required to contain certain information about the original manufacturing of a device (eg manufacturing specifications and product designs), which is typically required in a PMA. In the USA these manufacturing specifications are publicly filed, as are changes to the manufacturing specifications, allowing reprocessors to reference these materials. This considerably reduces the cost of reverse engineering which reprocessors would otherwise have to undertake. We propose therefore, that Article 15d of the PROPSED REGULATION requires manufacturers to publicly file manufacturing specifications and any changes thereto and that reprocessors are allowed to reference these documents in their regulatory filings. 3. The Article 15 b. procedure as currently drafted does not address arbitrary product design features whose sole purpose it is to limit reprocessability. This is a significant shortcoming as it is common practice for manufacturers to incorporate design measures exclusively intended to frustrate the reprocessing of their products (use of certain materials, geometry of the devices, electronic barriers preventing more than one use). This practice if allowed wound undermine the objective of the current proposals by the European Parliament, which is to permit a single use designation only if patient safety requires this. Manufacturers should therefore be required to demonstrate to the EU regulatory body that design features which limit the reprocessability of the device are required for the functionality of the device. If this cannot be demonstrated these design features should be removed. 4. Article 15 c. should be extended to products already in the market when the regulation comes into force, ie third party reprocessors should be able to have these legacy single use devices reclassified as reprocessable. If they have been certified as reprocessable under a member state regulatory regime (eg under the German RKI BPharm system) these certificates should be deemed as evidence of reprocessability. Similarly manufacturers should be given a period of one year to prove that their existing single use label is justified. If they provide no such evidence then they have the option of relabeling the device as reprocessable or taking the device off the market. 5. Provisions should be introduced requiring a detailed decription of the processes required for reprocessing a medical device (eg the specific sterilization method ETO, Plasma or Steam -, the procedures for cleaning and disinfection or the specific tests of functionality required) to be added to the regulatory filing. Only reprocessors that can demonstrate access to the relevant reprocessing technologies and compliance with these processes should be permitted to carry out reprocessing. Otherwise patient safety could be compromised. 6. The scientific evidence which a manufacturer provides to the Commission shall be made available upon request to any natural or legal person who wishes to reprocess the device and wishes to challenge the manufacturer scientific evidence

6 7. There should be some level of protection for the IP of the reprocessor who has developed and filed the amendment transforming a single use device into a reprocessable device. The reprocessor needs to invest time, effort and know-how to develop, test and file a reprocessing method. If subsequent to filing any competitor can apply this procedure this will limit the incentive of reprocessors to develop such methods. This could be addressed by allowing reprocessing only by those reprocessors who have filed reprocessing dossiers. 8. It is not defined what possibilities of appeal exist against decisions by the new regulatory body. Decisions of the EU Comission, can be challenged in the European Court. The decisions relating to Article 15b and 15 c are not decisions by the Comission but decisions by the new regulatory body. We propose that decisions by the new regulatory body are treated as EU commission decisions. 9. It should be clarified that a challenge by a manufacturer of a decision by the new regulatory body does not have delaying effect. Otherwise legal procedures could delay the reprocessing of products for a long time. ********* - 6 -