The Medical Devices Regulations 2002. Statutory Instrument 2002 No.618
The document is the statutory instrument, which outlines the requirement for the Medical Devices regulations 2002. It is divided into the following: - Part I: Explains the scope of the regulations Part II: General Medical Devices Includes: - a. Classification of general medical devices b. Essential requirements c. Determining compliance with relevant essential requirements d. CE marking and procedures for affixing CE marking e. Procedures for packaging to be sterilised f. Registration of persons placing general medical devices on the market Part III: Relevant information on Active Implantable Medical Devices Part IV: Information on In Vitro Diagnostic Medical Devices Part V: Notified Bodies, Conformity Assessment Bodies and Marking of products Part VI: Fees charged by the Secretary of State Part VII: General Enforcement and Miscellaneous Provides information on the statutory requirements for manufacturing, packaging, sterilising and placing on the market of medical devices as defined under the Act.