NHS European Office response to the European Commission Questionnaire on Medical Devices

July 2008

The National Health Service (NHS) is one of the largest publicly funded healthcare systems in the world providing the majority of healthcare in England. The NHS is committed to the principle of universal access to healthcare which is free at the point of use. Every 36 hours the NHS sees over one million patients who make use of a wide range of health services ranging from primary care, in-patient care, long term health care, ophthalmology and dentistry. The NHS is a major employer in Europe with 1.3 million people on its payroll.

This response has been coordinated by the NHS European Office[1]in consultation with NHS organisations. The views presented correspond to those questions which are directly relevant to the role of the NHS as a commissioner and provider of healthcare and do not attempt to answer some of the more technical or cost -related questions.

The NHS welcomes the European Commission’s proposals to merge the existing nine legal texts on medical devices into one single document. However we are concerned that some of the proposals in the consultation document are aimed at tackling areas where a problem may not exist. Furthermore, we are of the view that several of the proposals put forward by the consultation paper require further supporting evidence and clarification of their legal basis before being implemented. While we are in favour of the over-riding objectives underpinning the consultation, we do not support extending the role of the EMEA to cover medical devices, or diminishing the authority of the Notified Bodies. In short, we encourage the European Commission to concentrate on the consultation paper’s primary purpose of consolidating the legislative framework, before embarking on a wider set of actions.

Detailed response

  • Scope

The NHS supports the proposal to consolidate all nine existing harmonisation measures on medical devices into one single legislative text, on the condition that such a merger is carried out with due care to the specificities of each of the existing texts.

We welcome proposals to introduce a risk-based classification system for in vitro diagnostic medical devicesand would support this as part of a total review of the classification system for such devices. The current system is too rigid to allow for any individual characteristics within in vitro devices, and classification takes too long. A total review of the classification system for in vitro medical devices would help to overcome this.

The NHS is not aware of any medical devices which are not currently regulated at EU level. However, we agree that the scope of the medical devices directives should be extended to include medical devices consisting of, or containing, non-viable human cells or tissue or their derivatives, to address the regulatory gap identified in the consultation paper.

  • Quasi medical devices

The Consultation paper’s proposal to include ‘quasi medical devices’ under the umbrella of the medical devices regime raises a number of concerns. The NHS believes that including quasi-medical devices in the medical devices regime has the potential to cause considerable confusion. In particular, it could mislead some patients into believing that a quasi-medical device has a health benefit, rather than a purely cosmetic effect. As well as misunderstanding the purpose of such devices, patients may erroneously think that as ‘health products’ they would be available under public health systems. This would not usually be the case. In addition, patients may underestimate the risks associated with use of such devices, as they may perceive them to be ‘safe’ because they are regulated as medical devices. Any regime to regulate quasi medical devices should therefore not be associated with any health endorsement by government or public authorities

In the interests of clarity, the NHS believes that only devices that meet the current definition of a medical device should be regulated within the existing medical device regime. If additional regulation of quasi-medical devices is required for the protection of public health and safety, a separate (potentially similar/parallel) regime should be established for ‘cosmetic devices’.

  • The revision of the New Approach

Deviating, modifying or adding requirements to the New Approach should only be considered after the Commission has received notification of a particular problem by a Notified Body. As the NHS is not aware of any such problems at present it does not see any need to recommend changes to the New Approach.

  • Evaluation Procedures

No changes are needed to the essential requirements beyond what has already been achieved. If quasi medical devices are to be regulated by the medical devices regulation then they should meet the requirements of regular medical devices. In this respect they should have the right to classification, but not be entitled to any specific exceptions.

Where medical devices undergo technological change the existing medical devices legislation should be robust enough to deal with it and it should not become necessary to introduce any new requirements.

The NHS recognises the importance of corresponding interpretations of the essential requirements between Member States. However we are unable to provide evidence or cite instances of Member States introducing their own national specific device, method or material requirement.

Regarding the functioning and activities of the Notified Bodies the NHS agrees in principle with the six proposals outlined, however we believe that proposals two and three are already covered in the revision of the New Approach, while proposal four is already a requirement in the medical devices directives.

Furthermore while we would support the avoidance of ‘forum shopping’ by manufacturers, the NHS is not aware of any evidence of ‘forum shopping’ taking place.

We do not support coupling the proposals with either of the two options put forward in the Consultation paper but would favour option 1[2]should the Commission see a need to press ahead with one of them. We do not support transfer of authority away from the existing Notified Bodies to a centralised system of final designation and control of monitoring by the Commission.

The NHS considers that there is a lack of evidence to suggest that not having a system to evaluate high-risk medical devices has been problematical in the past. We would not oppose some public authority input into the approval of such devices but would encourage the Commission to give further thought to whether a specific system is absolutely necessary and how ‘high risk’ would be defined.

  • Role of the EMEA

The NHS does not believe it is appropriate to extend the competence of the EMEA into the medical devices legislative framework and questions whether such a proposal is in line with the principles of the New Approach. The authorityand responsibility of the Notified Bodies should first and foremost be supported and promotedby the European Commission rather than be superceded by the EMEA and a new ‘Medical Devices Committee’. The NHS believes that the EMEA does not have the appropriate levels of expertise in the field of medical devices to carry out the requirements of the evaluation process outlined in the consultation paper. Rather than widen the EMEA’s remit, we encourage the Commission to support the EMEA in its primary role of evaluating medicines.

Should the Commission press forward with the proposals outlined in the paper the NHS urges the Commission to make clear the legal basis behind extending the role of the EMEA, and to guarantee that the new evaluation system does not incur additional costs to the production and regulation of medical devices to the extent that it could result in fewer innovative technologies entering the marketand consequently restricting patients’ access to effective new innovations in care.

  • Vigilance

The NHS agrees with the need to improve the vigilance system for medical devices throughout Europe, but stresses that this should be approached in a way that introduces the minimum possible bureaucracy.

  • Imports, Exports and Counterfeiting

While the NHS supports in principle measures to tackle counterfeiting of medical devices, we are not aware of any evidence of a problem concerning counterfeit medical devices that would justify specifying new legal requirements.

In the context of imports, we would highlight the need to consider whether medical devices, or their components, imported into the EU have been produced in ethical working conditions.Although this is not something to be addressed through legislation, we would encourage the Commission to take this into consideration, and, where relevant, promote this principle in external contacts..

Contact:

Jenny-Lee Spencer

NHS European Office

Tel: 0044 (0)20 743 200

NHS European Office

July 2008

[1] The NHS European Oftice was launched in September 2007. It represents the English National Health Service. Its role is to inform the NHS of EU issues and to ensure that the NHS contribute positively to EU developments.

[2] ‘The reinforcement of controls on the nomination (including setting out and defining the role of accreditation) and monitoring of the Notified Bodies by member states