Medical devices

Health 10-01-2018

Commission reassures ‘worried’ member states on Health Technology Assessment

The Commission’s upcoming proposal on Health Technology Assessment (HTA) will focus on clinical aspects and leave member states to decide on economic or ethical parts, a European Commission spokesperson told
Health 03-05-2017

Brexit regulatory uncertainty ‘threatens UK med tech’

Regulatory uncertainty in the wake of Brexit could leave Britain's multi-billion-pound medical technology industry out in the cold, with separate regulatory systems threatening exports and jobs.
Health 06-04-2017

Parliament wants medical devices traced, scrutinised

After almost five years of talks with member states, on Wednesday (5 April), the European Parliament adopted two new regulations imposing stricter rules on medical devices’ safety.
Health 23-01-2017

Breast implant victims win payout from German safety body

A French court on Friday ordered German safety certifier TUV to pay €60 million in compensation to 20,000 women who received defective breast implants that the group had approved.
Health 21-10-2016

Andriukaitis: Health Technology Assessment will make EU healthcare ‘sustainable’

EXCLUSIVE / National healthcare systems should embrace the digital era and use Health Technology Assessment (HTA) to become truly sustainable and cost-effective, European Commissioner for Health and Food Safety Vytenis Andriukaitis told in an interview.
Health 13-06-2016

New medical devices rules should avoid ‘unnecessary’ red tape, industry says

The implementation of new rules on medical devices should avoid extra burdens and unnecessary bureaucracy, health industry officials have told
Health 23-10-2013

Parliament wants tougher medical devices control without extra burdens for SMEs

The European Parliament on Tuesday (22 October) voted to improve the control on medical devices via strengthened traceability rules and transparency of information for patients and medical staff, but without creating additional burdens for small manufacturers.
Health 26-09-2013

MEPs vote for stricter approval system for medical devices

The European Parliament's committee for the environment and public health (Envi) on Wednesday (25 September) voted for stricter rules on medical devices, including a new pre-market approval system, more transparency and better traceability.
Health 09-07-2013

Danes want chemicals out of medical devices

Danish Health Minister Astrid Krag wants phthalate chemicals, which are used to soften plastic, phased out as part of the EU's new medical devices regulation.
Health 05-07-2013

MEPs divided ahead of vote on medical devices

SPECIAL REPORT / A vote in the European Parliament's Environment, Public Health and Food Safety (ENVI) Committee over the EU's proposed new medical devices regulation, which was supposed to take place on 10 July, has been postponed until September to give lawmakers more time to work on compromise amendments.
Health 04-07-2013

Medical tech sector worried about innovation, SMEs

SPECIAL REPORT / The European medical technology industry worries that a centralised pre-market authorisation system in Europe will destroy innovation, research and development within the sector. It warns especially that small and medium-sized enterprises (SMEs) could disappear with the proposed new system.
Health 02-07-2013

Patient groups: Safety first in new medical devices regulation

SPECIAL REPORT / Recent health scandals involving faulty breast implants and toxic replacement hips have illustrated the need to strengthen safety checks on medical devices in the EU, according to patient groups. A new EU regulation currently in the works must rectify this by putting patient safety first, they argue.