Brussels, 31/03/2016 (Agence Europe) - The new Community rules aiming to avoid a repeat of the breast implants scandal is taking shape. Following three a half years of discussions, the Parliament and the Council should to be in a position to tie up matters on medical devices and in vitro medical devices under the Dutch Presidency of the Council of the EU. This is, at any rate, what emerged from the inter-institutional meeting held on 16 March.
The proposed regulations govern the marketing and monitoring of medical devices and in vitro medical devices. These texts, which are based around 200 articles and 30 appendices (or a total of 350 pages), lay down the checks on these devices following their sale. They clarify all of the powers and responsibilities of the approved bodies - third-party public organisations or private companies appointed by the member states to authorise the sales of devices with the “CE” label. Readers may recall that the Parliament reached its position at first reading in April 2014 and the Council did likewise in June 2015. Since then, seven trialogues have been held and, according to a number of observers, two more are expected to be needed in order to reach a final compromise.
Reprocessing, the main stumbling block. The question of reprocessing, on which was agreement had effectively been reached between the Parliament and the Council, was reopened at the last trialogue by the European Commission. This practice, which is banned in France and authorised under certain stringent conditions in Germany, consists of re-using a single-usage device following sterilisation. According to information we have received, the Parliament and Council had more or less agreed to ban reprocessing, whilst allowing the member states a derogation should they so wish. In such cases, manufacturers would have been obliged to obtain the “CE” mark, rather than hospitals and resellers (which would only have had to be supervised by approved body). At the last trialogue meeting, the Commission is reported to have stated that this practice could lead to market fragmentation and harm the principle of fair competition between operators. It is currently looking at a new version of this Article 15 and, at the next trialogue meeting, is expected to propose a reprocessing regime which does not differentiate between operators or between member states.
It is worth noting that other issues also remain outstanding, such as the idea of a control procedure for in vitro devices, or the rules to be applied to genetic tests on the internet, both issues which are very important to Peter Liese (EPP, Germany).
Outlines of the future agreement. The rule of thumb in any inter-institutional negotiations is that “nothing is decided until everything is decided”, but over their seven meetings, the co-legislators have already clarified many points:
- Classification: the text classes the devices into category I, category IIa, category IIb and category III depending on their use and inherent risks (category III devices being the highest-risk), with the manufacturers' obligations varying between the different categories. Under the draft compromise, medical devices containing nano-materials should be classed as category III devices if they present a high or median potential risk of internal exposure, category IIb if the risk of internal exposure is low, and IIa if the risk of internal exposure is negligible. Similarly, the new rules are expected to cover “substance-based devices”, 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 syrups which soothe 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 IIb in all other cases and category IIa if they are applied to the skin, nasal cavities or oral cavities down as far as the larynx.
The draft compromise will also apply to certain cosmetic devices: the Commission will be responsible for publishing and updating the consolidated list of cosmetic devices 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 a committee of experts of any new evaluation and compliance requests regarding innovative category III implants and active category IIb 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 so doing.
- 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 IIb and III, twice a year for IIa). They must also produce “trend reports” to take stock of the product's long-term development.
- 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.
- Comitology: the Commission will have to produce almost a hundred implementing/delegated acts as well as guidelines to clarify certain provisions (e.g. CMR).
The next trialogue will take place on 7 April. The Dutch Presidency aims to reach an agreement with the Parliament as soon as possible with a view to the formal adoption of the text at second reading by the Health Council of 16 and 17 June. (Original version in French by Sophie Petitjean)