Guide for Manufacturers of System and Procedure Packs regarding Legislative Requirements
09 August 2010
This document applies to all products that fall within the definition of a system or procedure pack under the European Communities (Medical Devices) Regulations, 1994, S.I. No. 252 of 1994, which will hereafter be called the ‘Regulations’. Active implantable and in-vitro diagnostic medical devices are outside the scope of this document. The requirements for post-market vigilance or adverse event reporting are also outside the scope of this document.
The manufacturer of a system or procedure pack which also contains a medicinal product must, additionally, adhere to the legislative requirements for medicinal products, particularly those relating to the distribution and sale of these substances. These requirements are outside the scope of this document. Further information on this aspect may be obtained by contacting the Compliance Department of the Irish Medicines Board (IMB).
Guide for Manufacturers of Systems and Procedure Packs regarding Legislative Requirements