EU proposes postponing medical device legislation by four years

To avoid shortages, the EU proposes postponing medical device legislation by four years.
The new regulation establishes stronger safety requirements than previous laws for tens of thousands of items sold in the EU, ranging from prosthetic limbs to blood glucose monitors, and requires all devices to be re-certified.
The EU Health Commissioner recommended postponing the deadline for corporations to comply with a new legislation governing medical devices from 2024 to as late as 2028 on Friday, a significant adjustment she claimed is required to avoid shortages of lifesaving equipment.
The decision, which was reported by Reuters on Thursday, comes in response to an uproar from physicians’ organisations and trade groups. They warn that if the Medical Equipment Regulation law, which went into force last year, is not amended, many critical devices would soon disappear from the EU market.
The new regulation establishes stronger safety requirements than previous laws for tens of thousands of items sold in the EU, ranging from prosthetic limbs to blood glucose monitors, and requires all devices to be re-certified.
Commissioner Stella Kyriakides told a conference of EU Health Ministers that, if approved, she will propose an amendment to adjust the deadlines for compliance with the regulation in January.
She advocated setting a new deadline of 2027 for manufacturers to certify high risk items under the new approach, and a deadline of 2028 for medium and low risk devices. She also proposed reducing a “sell-off” deadline of May 2025, so that existing items do not have to be discarded.
She stated that the new schedule will be formally submitted as an amendment to the legislation, which she would present at the start of next year.
The transition to a new regulatory structure for the EU’s multibillion-euro medical devices industry has taken longer than expected, according to Kyriakides.
That under new rule, all devices marketed in the must be re-certified by May 2024, including implants and prostheses, blood glucose metres, and pacemakers.
A lack of regulatory agencies, along with the COVID-19 epidemic and raw material shortages caused by the Ukraine crisis, “has put a pressure on market preparedness,” she added.
If the poor rate of certifications continues, the EU Commission warned earlier this week that thousands of gadgets presently sold in the EU might have their documentation lapse by the current deadline.
Following a 2010 controversy in which a French business profited from selling leaky breast implants, the new regulation attempts to better safeguard patients and customers.