{{ phone }} {{ location }}

Emergo by UL logo


european commission

European Commission Requirements for Marketing Medical Devices in a No-deal Brexit Scenario


  • Definition of “placing on the market” linked to economical ownership;
  • Economical ownership only counts for goods already produced;
  • CE Mark certificates of UK-based Notified Bodies will become void after Brexit day;
  • No exceptions made for medical devices when it comes to certificates.

EU Considers Applying Transparency Directive to Medical Devices

The European Commission may extend its Transparency Directive covering pricing and reimbursement transparency of medicinal products to medical devices. EU regulators have launched a public consultation in conjunction with a process review of the Transparency Directive (89/105/EEC) intended to revise pharmaceutical pricing rules, which have not been updated since 1989.

Eucomed: Ease Regulatory Requirements for Smaller-tier Medical Device Makers

European medical device industry trade group Eucomed has issued four major recommendations to the European Commission regarding easing regulatory requirements for small and medium-sized enterprises (SMEs) in order to foster innovation. Eucomed has published a position paper, European Health and SMEs: Big Challenges, Small & Medium Sized Solutions, following a survey the group conducted over the course of 2010 of 12 European national medical technology industry associations to pinpoint major regulatory barriers to SMEs.

Eucomed Proposes Wider Adoption of Remote Cardiac Device Monitoring Tools

European medical device trade association Eucomed has made adoption of technology to remotely monitor implantable cardiac devices a key element of its four recently submitted proposals to the European Commission Innovation Union Strategy's Active and Healthy Ageing Innovation Partnership program.