Members of the European Parliament’s health and environment committee voted today (25 September) to strengthen a European Commission proposal for new oversight on invasive medical devices.  

The proposal has been closely watched because it followed last year’s PIP breast implant scandal. Under current rules, dating from 1990, medical devices such as implants and pacemakers are given pre-market authorisation by accredited independent assessment bodies – known as ‘notified bodies’. There are roughly 80 of these bodies in the European Union, some public and some private.  

The Commission proposed that an EU-level supervisory co-ordination group be created to share information across member states. The committee position would make this EU authority much stronger, giving the EU scrutiny over notified bodies which handle the most complicated devices. This was a compromise between the centre-left, which wanted full EU authorisation, and the centre-right, who did not want central EU control.  

Eucomed, which represents the medical devices industry, blasted the compromise, saying it would create an “extremely heavy bureaucratic procedure which combines a complex, unpredictable scrutiny process with a de facto case-by-case centralised pre-marketing authorisation system (PMA).”  

“No-one has shown how any part of the proposed new PMA system would have changed the outcome of PIP or any other safety issue,” said Eucomed CEO Serge Bernasconi. “Bureaucracy will not prevent an alleged fraud like PIP. Concrete actions do.”  

Consumers group BEUC welcomed the committee vote. “Despite huge industry pressure, MEPs have put patient safety first,” said BEUC director-general Monique Goyens. “The Parliament has managed to enhance post-market monitoring and the new system will make it possible for consumers to report faults or mishaps. Furthermore, an appropriate increase in manufacturers’ liability will compel adequate compensation for harmed patients.”  

The committee also voted to ban harmful chemicals in medical devices. Phthalates would be banned from January 2020, and substances that are potentially cancer-causing, toxic to the reproductive system or distrupt the endocrine sustem would be phased out within eight years of the adoption of the law, if alternatives are available. The medical devices have opposed an outright ban, saying the legislation needs to take better account of product categories where alternatives are not available.

The MEPs rejected the Commission’s idea to make all devices containing nanomaterials go through the stricter pre-market authorisation process. The committee’s position would only apply this stricter process to products that intentionally release nanomaterials into the body.

Member states have not yet begun discussions on the dossier, prompting centre-right German MEP Peter Liese, who is guiding the legislation through the Parliament, to fear it will not be adopted before the end of this Parliament.   

“The text has been on the table for a year and the Council hasn’t agreed on anything yet,” Liese said last week. “The Lithuanian presidency needs to speed it up. I cannot go to elections in May and say, yes we have understood that there are big problems [after the PIP breast implant scare], but all we’ve done is a first reading, after one year.”  

Separately, the Commission yesterday adopted two measures to improve medical device safety, in response to the PIP scare. The measures require member states to conduct a ‘joint assessment’ with experts from the Commission and other member states before it authorises a notified body. It also requires member states to carry out surveillance and monitoring of notified bodies, and requires the notified bodies to conduct unannounced factory visits for the products they have authorised.  

“The measures that the Commission adopted yesterday do clearly help prevent incidents such as the PIP happening again…and are fully supported by the industry,” said Bernasconi.