Brussels, 28 October 2013
In a common press release, AIM, l'ISDB and the Medicines in Europe Forum observe that, although some small improvements have been made on the assessment of high-risk medical devices, major flaws remain in the legislation.
> Download the Common Press Release (pdf, 153 Ko)
Common Press Release
On 22 October, the European Parliament voted in the plenary on the report of MEP Roth-Behrendt as adopted by the ENVI Committee on the regulation of Medical Devices. While the Report of MEP Roth-Behrendt had managed to introduce more transparency on clinical data and the ENVI Committee proposed stricter rules for assessment before certain high-risk medical devices can reach the market (novelty of the device, safety concerns), MEPs in the plenary largely watered down this compromise. AIM, ISDB and MiEF warn that the opportunity to prevent large-scale scandals such as the hip implants case should now be seized by the Council.
Public health defenders – mutual and health insurance funds, patients' and consumers' organisations, health professionals and independent drug bulletins – have been struggling for years for safer high-risk medical devices submitted to pre-market assessment of their efficacy, based on strong evidence. We therefore require high-risk medical devices to be systematically submitted to pre-market assessment of their efficacy and safety, which is not happening now (1)(2). The introduction of specialised notified bodies approved by the European Medicines Agency and the creation of an Assessment Committee for Medical Devices (ACMD) giving a binding opinion on high-risk devices are indispensable measures if patients' safety is to be improved. These measures formed the basis of the compromise as adopted by the ENVI Committee. However, in plenary, MEPs put economic interest ahead of patient safety, watering down this compromise. They decided to reduce the scope of the ACMD making its opinion optional (if the MDCG requests it) and submitting only some of the high-risk medical devices of Class III and IIb to a clinical assessment. In fact, the opinion of this Committee should be binding.
This is a disappointing result: patients remain exposed to possible flaws for the many high-risk devices escaping specific assessment of the ACMD (and the MDCG) (3).
On the issue of clinical data, small improvements have been made. MEPs approved a measure whereby the industry can no longer deny access to scientific data by claiming commercial confidentiality. Access to clinical investigations' results on medical devices should be easier. Anyhow, they rejected the evaluation of new medical devices versus comparator, which was a great proposal to improve the quality of medical devices.
A positive aspect is the introduction of compulsory liability insurance for manufacturers. The liability insurance covering insolvency and damages to patients will make sure that the patients who suffered harm caused by a faulty medical device will be covered if the damage is recognised.
In conclusion, some small improvements have been made on the assessment of high-risk medical devices but major flaws remain in the legislation. The gap has not been filled, to help prevent any future scandal. AIM, ISDB and MiEF therefore ask the Council to go further and strengthen pre-market assessment of all high-risk medical devices in order to protect patients.
©AIM, ISDB, MiEF October 2013
References:
1 Nicola Kuhrt "Sales Over Safety: Medical Device Makers Battle Tougher EU Laws" October 17, 2013, Der Spiegel www.spiegel.de/international/europe/medical-device-makers-lobby-against-tighter-eu-licensing-rules-a-928191.html
2 Deborah Cohen "Devices and desires: industry fights toughening of medical device regulation in Europe" October 16, 2013 BMJ 2013; 347: f 6204. http://www.bmj.com/content/347/bmj.f6204 (with a quotation of Christian Zahn, AIM Vice-President)
3 Christian Zahn, AIM Vice-President, “EU medical devices directive a 'missed opportunity'” October 22, 2013, The Parliament, http://www.theparliament.com/latest-news/article/newsarticle/eu-medical-devices-directive-a-missedopportunity/#. Um4hVZ1kCP8
> Download the Common Press Release (pdf, 153 Ko)
