European Commission Publishes Recommendation on the Audits and Assessments Performed by Notified Bodies in the Field of Medical Devices

Brussels – 24 September 2013

Today, the European Commission published a recommendation on the audits and assessments performed by notified bodies in the field of medical devices. The Recommendation provides general guidelines for product assessments, quality system assessments and unannounced audits. The guidelines do not include new rights or obligations, but aim to ensure that notified bodies carry out a proper verification of the fulfilment of the legal requirements by the manufacturer.

List of harmonized standards for machinery

European Commission updates list of European Harmonized Standards for the Machinery Directive (2006/42/EC)

On April 5, the European Commission published an updated list of the European harmonized standards that pertain to the Machinery Directive (2006/42/EC). The standards on this list may be used by machinery manufacturers to prove that their machinery complies with the essential requirements of this directive.

Report shows fewer dangerous products reaching EU market

Brussels, 08 May 2012 – EU consumers want to be sure that the products – whether produced in the EU or imported from third-countries – are safe. The good news is that thanks to the increasing effectiveness of the EU’s rapid alert system for non-food dangerous products (“RAPEX”) dangerous products are detected earlier and more effectively and are more promptly removed from the EU market. This process involves a chain of actions including upstream efforts to design out risks at source, better risk assessment and close co-operation between EU authorities, notably customs, to identify risks at the points of entry.

List European Harmonized Standards for the Medical Devices Directives (93/42/EEC, 90/385/EEC, and 98/79/EC) Updated

On Friday 27 April 2012, the European Commission published updated lists of the European harmonized standards that pertain to the Medical Devices Directive (93/42/EC), In Vitro Diagnostics Directive (98/79/EC), and the Active Implantable Medical Devices Directive (90/385/EEC). The standards on these lists may be used by manufacturers to prove that their equipment complies with the essential requirements of this directive.

The updated list are important to all manufacturers of CE marked medical devices, active implantable medical devices and in vitro diagnostics that have used European harmonized standards to prove CE compliance. If you have applied standards to prove compliance with the aforementioned directives, re-evaluate your products against the updated standards and update your Declaration of Conformity.

European Commission updates list of European Harmonized Standards for the Machinery Directive (2006/42/EC)

On 29 February, the European Commission published an updated list of the European harmonized standards that pertain to the Machinery Directive (2006/42/EC). The standards on this list may be used by machinery manufacturers to prove that their machinery complies with the essential requirements of this directive.

Where the European Union stands on reducing administrative burdens

The Commission’s efforts to reduce regulatory burden, including administrative burden, are part of its smart regulation agenda. Smart regulation should ensure that European laws benefit people and businesses. It is essential if the EU is to deliver the ambitious objectives for smart, sustainable and inclusive growth set out by the Europe 2020 Strategy. The Commission therefore evaluates the impact of legislation during the whole policy cycle: when a policy is designed, when it is in place, and when it is revised. As smart regulation is a shared responsibility of all those involved in EU policy-making, the Commission works with the European Parliament, Council and Member States to encourage them to apply smart regulation in their work. Below the Commission presents an overview of achievements and examples in administrative burden reduction.