EU Labeling, Vigilance and EN 60601-1 News
Guidance on CMC labeling decision
As we mentioned last year, the Central Management Committee (CMC) on Medical Devices made a decision in 2011 that affects labeling for manufacturers and Authorized Representatives. The decision was made to achieve a common interpretation of the manufacturer’s address requirement as expressed in the Essential Requirements. We have noted that there will be a draft guideline describing how Competent Authorities will enforce the CMC Decision, though Emergo Group’s guidance has always reflected the CMC Decision. The CMC decision becomes effective 1 September 2012, at which point manufacturers will be required to include their complete street address, postal code, city, state, and country.
On the topic of vigilance, the EU Commission web site now offers the Trend Report Forms and PSUR Forms of MEDDEV 2.12/1. The FSCA Report form has also been updated to reflect revision 7.
Standard changes in the EU: EN 60601-1 3rd Edition and ISO 13485:2012
While not mandatory, compliance with European Norm (EN) harmonized standards published in the Official Journal of the European Union (OJEC) presumes compliance with relevant Essential Requirements. EN 60601-1, 2nd Edition, relating to electrical equipment, will finally lose its harmonized status this summer. The 3rd Edition will be adopted in its stead. On June 1, 2012, the 2nd Edition will no longer offer a presumption of conformity (or be considered “state of the art”).
There is a dramatic revision between the two editions. An EU working document for the new edition addressing the question about retesting states: “In general: yes, retesting is necessary because of the many differences [between the editions].” Additionally, many Notified Bodies (NB) offer their own guidance on the upcoming standard change. One NB suggests a technical gap analysis with a comprehensive technical rationale and perhaps limited testing. We strongly recommend that a strategy be developed to address compliance with the 3rd edition, and the NB be engaged in discussions as soon as possible.
There is less difference in the update from EN ISO 13485:2003 to the new EN ISO 13485:2012. The European Commission recently raised concerns about the legal text in standards supporting presumption of conformity to the Directives. As an outcome, the European Committee for Standardization published EN ISO 13485:2012 with a revised Foreword and Annexes ZA, ZB and ZC. The core text remains unchanged.
Italian repertorio fee to be dropped
Last, an update from Italy. Member states may require notification of Class IIa, IIb, III, AIMD, and IVD devices. To this end, the Italian registration system serves two purposes. First, registration of all Class IIa, IIb and III AIMDs is required under the Italian transposition of the Directives. Second, the listing provides an online catalog (or “repertorio”) of devices that may be purchased by healthcare facilities within the Italian National Health Service. Until now, a €100 “repertorio fee” has been charged by the Italian Ministry of Health for each device family registration. A new Decreto, effective from 3 April 2012, has rescinded this payment. Thus, with immediate effect, there are no repertorio fees when registering new device families in Italy. There is, however, no provision for previously submitted fees to be refunded.