Europe medical device QA/RA blog

News and commentary on regulatory changes.

Italy registration deadline extended; recast of WEEE/RoHS; adverse event reporting possible changes

Medical devices sold in Italy were required to be registered in the Italian Ministry of Health database by December 31, 2008. However, the Italian MOH just announced that this deadline has been extended to April 30, 2009. Again, registration only applies to companies currently selling their products in Italy.

Commission proposes revisions to electrical and electronic equipment recycling and use of hazardous substances

The European Commission proposed a recast of the Directive on Waste Electrical and Electronic Equipment (WEEE) 2002/96/EC and the Directive on the Restriction of the Use of Hazardous Substances in Electrical and Electronic Equipment (RoHS) 2002/95/EC. According to the Press Release (IP/08/1878), the two main objectives of the revision are to improve implementation and enforcement of laws on electrical and electronic equipment and diminish unnecessary administrative burdens.

In the past four years, only one third of electrical and electronic waste was compliant to the directives while legislation has been costly and difficult to implement and enforce. The new WEEE Directive would harmonize producers' registration and reporting obligations as well as develop interoperable national registers. The new RoHS Directive would include medical devices and monitoring and control instruments. The text of the proposed revisions are available online:

Extensive impact assessment documents are also available:

Commission promotes patient safety, including prevention and control of healthcare associated infections (HCAI).

In its press release (IP/08/1973), the European Commission announced its comprehensive approach to improve patient safety with a Communication (COM(2008)836) and a Council Recommendation (COM(2008)837) on patient safety, including prevention and control of HCAI.

The Commission recommended that member states establish or strengthen reporting and learning systems on adverse events and develop systems that would adequately describe errors or near misses: extent, type, and cause. Member states were also advised to encourage health care worker reporting. Obviously, there are recommendations for national policies and programmes, one of which is to empower and inform patients. Information from the European Commission web site:


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