Mixed response to watered-down medical device safety regulations

New rules to ensure all kinds of medical devices including hip replacements and breast implants are safer have been watered down by the European Parliament.

Aggressive industry lobbying was blamed for the result by the MEP responsible for managing the legislation through the parliament, Dagmar Roth-Behrendt.

The scandal that saw thousands of women with unsafe breast implants from the French PIP company focused attention on medical devices in 2011 and led to demands for tougher regulations.

The European Commission put forward a regime which sees all implants tested and passed as safe before being put on the market.

However, MEPs voted that just some of the devices classified as high-risk would be subject to such monitoring — it includes breast implants that were moved into the Class III category after the PIP scandal.

Ireland is home to around 130 medical device companies and around 100 SMEs servicing them with an annual turnover of around €8bn a year, or about 9% of the country’s total exports. It employs more than 25,000 — the highest proportion per population of any EU country.

Fine Gael MEP Máiréad McGuinness said the draft tightened current rules and addressed concerns about patient safety while allowing the industry to be innovative.

The new rules will increase the traceability of devices and allow for unannounced site visits to manufacturers, said Sinead Keogh, director of the Irish Medical Devices Association.

The failure to establish a system of pre-marketing authorisation was blamed on “aggressive and uninformed lobbying from the industry” by Ms Roth-Behrendt.

“We have partly achieved our main objectives today: to better protect patients from defective products and create a more efficient system for granting market access for new devices. This is a step in the right direction, but unfortunately it is not a milestone,” she said.

However specialists will re-examine some devices where new technology is involved or when problems are reported but their recommendations as a result of the clinical tests will not be binding on member states, she said.