Out-Law News | 23 Oct 2013 | 4:34 pm | 3 min. read
On Tuesday the European Parliament voted to back changes to the rules governing the regulation of medical devices. MEPs backed a package of reforms that contained amendments to original proposals laid out by the European Commission last year. A new Regulation on medical devices (194-page / 646KB PDF), and a separate Regulation on in-vitro diagnostic medical devices (143-page / 501KB PDF), are envisaged under the reforms.
Under the European Parliament's proposals, which need the support of EU Ministers before they become law, 'medical devices' would not be subject to "pre-market authorisation" by regulators. Instead, manufacturers would be required to undertake a "conformity assessment", in partnership with designated 'notified bodies' (NBs), to ensure that the devices are certified as meeting quality management and other standards prior to their release to market.
Manufacturers would have to employ suitably qualified individuals responsible for ensuring regulatory compliance, under the plans. One of their duties would be to ensure that "the conformity of the devices is appropriately assessed before a batch is released".
NBs are generally private companies paid by the manufacturers to certify their products. Under the reforms, NBs would be subject to regulatory monitoring and could be issued with penalties if they fail to comply with the minimum standards laid out under the new medical devices Regulation. Regulators would also have the power to undertake unannounced inspections at manufacturers' premises.
If the Parliament’s proposed form of the new medical devices regulations is approved, only a limited number of notified bodies with the appropriate specialist scientific expertise and knowledge will be able to assess devices classified as "high-risk", such as implantable devices.
"There were concerns within the industry about any move that would have required manufacturers to obtain pre-market authorisation from regulators before being able to sell their products within the EU," said medical devices expert Indradeep Bhattacharya of Pinsent Masons, the law firm behind Out-Law.com. "Industry is understandably pleased that this requirement has been omitted from the Parliament's approved text."
Eucomed, which represents around 25,000 designers, manufacturers and suppliers of medical technology, said that MEPs had "improved some very essential elements of the approval system". However, it said that further improvements could still be made, and that it may be possible to scrutinise high-risk medical devices on a "post-market" rather than "pre-market" basis in accordance with "post market controls".
Under the reform package backed by MEPs, medical device manufacturers would be required to take out appropriate liability insurance covering them from damages caused to patients or users stemming directly from a "manufacturing defect". The level of coverage should be "proportionate to the potential risk associated with the medical device produced".
Medical devices put onto the market would also have to be given a unique device identification to ensure their traceability, under the Parliament's proposals. This broadly the recommendations made by the Commission.
In addition, new rules relating to the reprocessing of single use medical devices have been approved by the MEPs. A new list outlining which devices can be reprocessed is to be created, whilst a separate list indicating which devices are capable of single-use only is also to be formed. If devices are not listed specifically as 'single-use' only, they could be "reprocessed" by health bodies and others.
'Reprocessing' concerns the range of activities that need to be undertaken to ensure used medical devices can be safely reused. It involves the cleaning, disinfecting and sterilisation of used devices, and the re-testing of their "technical and functional safety", among other things.
Health bodies and others conducting this reprocessing would be liable for that activity and be considered to be the manufacturers of reprocessed devices, meaning they would be subject to all the regulatory requirements set out in the Parliament's draft, excluding obligations linked to conformity assessments.
"The Parliament-backed proposals appear to achieve a relative compromise between a very pro-regulatory stance and a light-touch approach, particularly by avoiding additional red-tape that would have been associated with pre-market authorisation requirements," Bhattacharya said. "It will be interesting to see how the proposals are received in the negotiations with EU Member States."
"The accepted norm has been that new medical devices hit the EU market sooner than they do in the US, where the Food and Drug Administration pre-approves devices before they are sold. The original European Commission proposals sought to maintain this competitive advantage on innovation whilst ensuring a stiffening of the regulation of those devices in light of the heavily publicised scandals in relation to defective breast implants and hip replacement parts. Whether both objectives can be achieved will be in the balance until a final text is agreed," he added.
A final text is not likely to be agreed until at least early 2014.