Brussels, 26 April 2012 – The European medical technology industry association Eucomed welcomes most of the measures in the PIP resolution proposed by the Environment and Public Health (ENVI) Committee of the European Parliament. The PIP resolution was passed unanimously yesterday. Many of the measures will improve the current legislative framework for medical devices and have a positive effect on patient safety. However, Eucomed does not understand the need to call for a pre-market authorisation system for Class III devices as Europe currently has a de facto approval system for these devices.
Eucomed recognises the need for improving the effectiveness of the current European regulatory framework for medical devices and has called for a legal framework that provides a consistent, EU-wide regulatory approach through improved coordination, evaluation and certification of medical devices; consistent and comprehensive implementation across all EU Member States, as well as efficient vigilance and market surveillance systems. Europe needs smart regulation that makes efficient and effective use of existing resources and involved structures (European Commission, Competent Authorities, Notified Bodies and industry) so as to retain a simple, adaptable and highly efficient system and merit public confidence.
Eucomed welcomes most of the measures in the PIP resolution such as:
- the strengthening of the designation and control of Notified Bodies in the EU, also with respect to their skills and resources;
- better vigilance reporting and coordination of member states on incident assessments;
- increased and unexpected controls of manufacturers by notified bodies based on experience from the post-market phase;
- establishing tools to ensure the traceability of devices, in particular implants;
- establishing registers for implants and having the registers interconnected.
In addition it is a very positive signal that the ENVI committee recognises the need for innovation in order to address current and future healthcare challenges. This should also be reflected in the revision of the medical devices legislation that is currently being drafted by the European Commission and is expected to be published before the summer.
Eucomed is surprised that some of the adopted positions are not fact-based and could potentially mislead public opinion. For example, the metal-on-metal hip incidents are positioned as proof of the failure of the European system. This is inaccurate as these devices were also granted access in other large markets such as the United States and the regulatory authority in the UK (MHRA) was the first in the world to issue guidance. Eucomed is confident that the debate around the regulatory system will continue and that these misperceptions will be discussed before the Commission’s proposal comes out in the summer.
One element of the current resolution that needs clarifying is the confusion with pharmaceuticals and the suggestion that medical devices need a pre-market authorisation system. The confusion centres on the difference in availability of clinical evidence for pharmaceuticals and medical devices.
To clarify, an appropriate clinical evaluation of clinical data is required for all medical devices before they are marketed. In particular, for both implantable devices and devices in Class III, the clinical evaluation must be based on data obtained from clinical investigations unless it is justified to rely on existing clinical data.
When comparing the clinical data requirements for devices and drugs, it is worth highlighting that for pharmaceuticals randomized control trials are relatively straight-forward to perform, and efficacy and relative safety can be statistically demonstrated in support of obtaining a marketing authorization provided that the clinical trials are sufficiently powered (depends on the number of patients). For some medical devices, randomized clinical trials are impossible to perform (e.g. it is impossible to implant a placebo hip). Unlike in pharmaceuticals, randomized clinical trials are not the ‘gold standard’ for assessing effectiveness and safety in medical devices because:
- Most devices cannot be evaluated with randomized clinical trials as it is hard to blind and randomize due to strong ethical and practical issues in the choice of the ‘comparator’ (e.g. what would have been a comparator for an implantable cardiac defibrillator? How would one implant a placebo hip?).
- Device impact depends on clinician training and experience, patient selection and the care delivery setting. This varies per doctor, hospital, region and country and is thus nearly impossible to predict with any precision. We therefore believe that ‘real world’ data from observational studies performed under routine conditions are equally important (structured post market surveillance).
In summary, medical technologies are part of the whole healthcare delivery system and their efficacy relies on the skills and experience of the physician, the quality of the hospital, and many other factors (contrary to pharmaceuticals). Suggesting that a pre-market authorisation system is needed is inaccurate as Europe currently has a de-facto approval system for Class III devices.