1. Medtech Insight
  2. >>Geography
  3. >>Europe

Pre-Market Question Attracts Debate At EU Parliament Session On Device Reforms

The Committee held a workshop Feb. 26 to address a proposal issued last year by the European Commission to impose reforms on EU device oversight. Some members of Parliament and others in Europe believe the proposal may not go far enough when it comes to pre-market oversight.

The level of government review necessary before a high-risk device is launched in markets in the European Union was a main point of contention at a workshop convened last month by the European Parliament’s Environment, Public Health and Food Safety Committee.

The Committee held the session Feb. 26 to address a proposal issued last year by the European Commission to impose reforms on EU device oversight

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Medtech Insight for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required
Start Free Trial

Already a subscriber?

More from Europe

More from Geography

FDA Announces Classifications On 8 Device Types

 
• By Elizabeth Orr

The US Food and Drug Administration has announced new classifications for eight device types that reached market via the de novo process, with most of the newly classified products in the diagnostics sector.

Medical Devices Not The Focus Of FDA’s Plans To Step Up Foreign Inspections, Expert Says

 
• By Brian Bossetta

The US FDA recently announced plans to carry out more unannounced inspections of foreign facilities. But those inspections will primarily target drug producers, with less attention and resources allocated to those making devices.

State And International Enforcement Agencies May Step Up Amid Uncertain Federal Environment

 
• By Elizabeth Orr

States and international regulatory bodies may increase their US enforcement role following federal staff cuts, Hyman Phelps & McNamara attorneys said in a recent webinar. The attorneys also expect False Claims Act enforcement and public health to remain key areas of focus at the federal level.