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 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.

List European Harmonized Standards for the ATEX Directive (94/9/EC) Updated

On Friday 4 May 2012, the European Commission published an updated list of the European harmonized standards that pertain to the ATEX Directive (94/9/EC), the European CE directive that applies to equipment used in potentially explosive atmospheres. The standards on this list may be used by manufacturers to prove that their equipment complies with the essential requirements of this directive. The list introduces two new European harmonized standards: 1. EN 13617-2:2012 Petrol filling stations – Part 2: Safety requirements for construction and performance of safe breaks for use on metering pumps and dispensers. This standard replaces the 2004 version with the same number. By 30 September of 2012 the new standard must be applied in order to keep benefiting the presumption of conformity. 2. EN 60079-11:2012 Explosive atmospheres – Part 11: Equipment protection by intrinsic safety ‘i’ (IEC 60079-11:2011). This standard replaces the EN 60079-11:2007 + EN 60079-27:2008 + EN 61241-11:2006. By 4 August of 2014 the new standard must be applied in order to keep benefiting the presumption of conformity. This updated list is also important to all manufacturers of CE marked ATEX that have used European harmonized standards to prove CE compliance. If you have applied standards to prove compliance with the aforementioned directive, we recommend you to check the new list of standards to see if any of the standard you applied have been updated, or whether there are new standards available for your products. When standards have been updated by this list, you need to re-evaluate your products against the updated standard and update your Declaration of Conformity. The updated list of standards can be found in our Library shortly.

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.