IEC 60601-1 3RD EDITION STANDARD AND THE MARKET ACCESS RULES FOR MEDICAL DEVICES IN NORTH AMERICA
In recent years, there has been a noticeable increase in the number of certifications for electro-medical devices awarded both under the US ANSI/AAMI and the Canadian CSA2 version of the IEC 606601-1, 3rd edition standard3. The legal market access requirements for electro-medical devices in the US and Canada are slightly different from other major markets. The workplace safety and its related certification requirements must beconsidered.
HIGHER-RISK ELECTRO-MEDICAL DEVICES ON THE NORTH AMERICAN MARKET
To place higher-risk electro-medical
devices on these markets, manufacturers have to submit device application files to US FDA and Health Canada. In most cases, this process runs in parallel to the certifications that a manufacturer wishes to gain for the two countries. For example, with IT products a certification mark by itself may be adequate to ensure market access. Furthermore, both in the US and Canada certification marks are required for the workplace safety of electrical & electronic (E&E) devices.
In the US and Canada the certification process based on the IEC 60601 3rd edition is quite different from for example the CE marking process or other country-specific certifications for electro-medical equipment.
THE REGULATORY TIMELINE FOR IEC 60601-1 3RD EDITION
For the 2nd edition of the IEC 60601-1 standard, up until recently no withdrawal policy has been in place in the US or in Canada. Existing medical devices that obtained certification based on the 2nd edition of the standard do not need to be recertified to meet the requirements of the new 3rd edition, unless a major revision is being made to the product.
PROPOSED WITHDRAWAL DATES
In the future, Canada has announced that
the old CAN/CSA 60601-1 2nd edition will be withdrawn on 1 July 2014 and the new 3rd edition will become mandatory for new devices submitted for certification. The US has not made public any withdrawal date yet, so certification to the 3rd edition of the 60601-1 standard remains optional. However, because the 3rd edition is required for the European markets, medical devices manufacturers are encouraged to use the 3rd edition for products destined for the US market as well.
IEC 60601: NORTH AMERICAN MARKETS
The version of the IEC 60601 standard used in the US is not a UL standard anymore, but rather the ANSI/AAMI ES60601-1: 2005. For types of products where there is no national ANSI/AAMI part 2 standard published in the US and Canada, for certification purposes the part 2 of IEC version of the standard is being used. Also, for workplace safety certification marks issued by nationally recognised testing laboratories (NRTLs), OSHA is currently reviewing NRTL applications for the ANSI/AAMI ES60601-1, 3rd edition, with its Amendment 1. Generally, for the US and Canadian markets, the 3rd edition of the IEC 60601 standard is greatly preferred. It will bring manufacturers more advantages in the long run, as opposed to using the 2nd edition; however, for lower risk medical devices that do not need to be submitted for US FDA approval, the old 2nd edition of the standard is still a viable option. But be warned, after 1 July 2014, the 2nd edition is not an option anymore for the Canadian market. In the US and Canada there are some national differences within the IEC 60601-1 3rd edition standard compared to the IEC version. The number of differences is considerably smaller compared to the old 2nd edition. Currently the differences have mostly to do with local electrical code practices (e.g. building wiring and wire securement practices, wires color coding, etc.).
THE PARALLEL ROLE AND REQUIREMENTS STEMMING FROM IEC 60601
Test reports received by manufacturers from independent certification bodies often fulfil more than one need. As the IEC 60601 standard is globally harmonised, international CB Scheme test reports can be used for receiving a certification mark for the US and/or Canadian market. They may also be submitted to Australia’s TGA. Furthermore, such test reports might also be used to declare conformity with the essential requirements of the Medical Devices directive. In North America, parts of the test reports may also form the basis for the technical file that has to be submitted to Health Canada or in the US for the FDA 510(k) file or an FDA Premarket Approval (PMA) file for non-exempt devices.
FDA AND HEALTH CANADA ADOPTION OF IEC 60601-1 3RD EDITION
The FDA has already adopted the 3rd third edition of the 60601 standard in its entirety as consensus standards. From 1 January 2014, FDA requires the 3rd edition of the standard for new product submissions, while for existing products the 2nd edition of the standard is still acceptable. Health Canada has already harmonised its adoption timetable of the 3rd edition of the 60601 standard with that of the EU. The 3rd edition became mandatory for new product submission on 1 June 2012. However, Health Canada allows for a three-year grace period for complying with the new standard, if manufacturers can provide sound technical reasons for the need to make use of the grace period.
For gaining a certification mark for electro-medical devices, the preferred standard by most North American regulatory bodies is now the 3rd edition of the IEC 60601-1 standard. The 3rd edition is included in the scope of certification organisations assessed by the Standards Council of Canada, while in the US it is in the ISO 17025 scope of the laboratories, and soon to be in their NRTL scopes as well.For more information on SGS Medical Devices Services in North America and around the globe visit SGS Medical Devices or contact us.