Brussels, 26/05/2016 (Agence Europe) - The European Union will soon have new standards for ensuring the quality and safety of medical devices and in vitro medical devices. On Wednesday 25 May, the European Parliament and Council managed to reach an agreement on two proposals for a regulation on the subject. The Commission, however, did not support the compromise.
The legislative proposals date from 2012 and provide rules for the marketing and follow up of medical devices and in vitro medical devices. They strengthen the surveillance of products deemed dangerous and provide more powers to the approved bodies (the third-party public organisations or private companies appointed by the member states and responsible for the marketing of devices that have the "EC" label). The main objective is to prevent new health scandals arising, such as the one involving adulterated breast implants manufactured by the PIP company in 2010 or the metal on metal hip prosthetics in 2012.
The difficult question of withdrawal. During the 10th trilogue on 25 May, the co-legislators ultimately completed the 400 pages of proposals. They managed to settle the last pending question, namely the one on withdrawal. They decided to ban this practice, which consists of reusing a single use device after sterilisation, unless a member state introduces a derogation for a device that is not included on the EU "negative list". This reference to a negative list had been supported by the Parliament and Council for a long time but had been largely opposed by the Commission, which wanted it to be removed or replaced by a positive list. According to one observer, the Commission's position can be explained by it not wanting to be held responsible in the event of another health scandal. At the end of the trilogue, the Commission therefore announced that it was unable to support the overall compromise due to the question of withdrawal and, to a lesser extent, the question of data confidentiality. This decision, however, is not expected to block the legislative process, at least not for the time being. The question, however, will certainly arise again at the end of the year during the final adoption of the text.
Future rules: the new regulations include more upstream and downstream surveillance.
Classification: the text divides the devices into class I, class II a, class II b and class III, depending on their usage and their inherent risks (the devices in class III contain the highest risk); manufacturers' obligations vary according to the category decided. According to the compromise text, medical devices containing nano-materials should be considered as devices: class III if they present a potentially high or medium risk of internal exposure; class II b if the internal risk exposure is low; class II a, if the internal exposure risk is negligible. Similarly, the new regulation will cover "Substance-based", in other words, products similar to medicines but which do not come under the relevant legislation due to their mechanical function (rather than a pharmacological or biological function), such as cranberries to treat urinary infections or cough syrup which soothes the larynx. The draft compromise classes these products as category III devices if they are absorbed or are intended to act on the stomach or intestines, category II b in all other cases and category II a if they are applied to the skin, nasal cavities or oral cavities down as far as the larynx.
The compromise will also apply to certain cosmetic devices: the Commission will be responsible for publishing and updating the consolidated list of cosmetic device is classed as medical or in vitro devices and for drafting common specifications for each product or group of products.
Control procedure: the draft agreement brings in an obligation for approved bodies to inform the committee of experts of any new evaluation and compliance requests regarding innovative category III implants and active category II b devices (used to administer or withdraw medicines). The text gives the committee of experts 60 days to respond. For its part, the approved body is not obliged to take account of the opinion of the experts, as long as it can provide reasons for doing so.
- Liability: in-line with the directive on faulty products (85/374/EEC), the text lays down liability for the manufacturer in the event of damage. This means that the manufacturer must take out insurance or subscribe to a compensation fund. The text is expected to specify that the member states can choose to go even further. Manufacturers are also obliged to produce regular reports on product safety updates (annually for devices of category II b and III, twice a year for II a). They must also produce "trend reports" to take stock of the products long-term development.
- Endocrine disruptors, medical devices containing endocrine disruptors or CMR substances (carcinogenic, mutagenic, harmful to reproductive health): the text requires manufacturers to provide justification if any device contains endocrine disruptors or CMRs to a level of more than 0.1% of its mass. For its part, the approved body must carry out checks.
- Genetic Advice: the new rules stipulate that patients must be informed when it is appropriate, of the implications resulting from the use of an in vitro device used to diagnose predispositions to a disease.
Comitology: the Commission will have to produce almost 100 implementing/delegated acts as well as guidelines to clarify certain provisions (such as CMR).
The compromise text now has to be formally endorsed by the European Parliament and Council, following translation and verification by legal linguists. The new rules are expected to apply three years after adoption for medical devices and five years after for in vitro devices. (Original version in French by Sophie Petitjean)