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From January 1, 2018, the Amendment 1 to IEC 60601-1 3rd edition applies for the production of electrical medical devices that are supposed to be marketed in the EU. The corresponding EU standard EN 60601-1:2006/A1:2013 was published on May 13, 2016, and added to the list of harmonized standards (C173/100); a transition period until December 31, 2017, was defined. The oncoming end of transition reminds to deal with the changed requirements as soon as possible. To do so in daily work, there is a consolidated version to refer to, where the changes of the Amendment 1 are colored (ISBN 978-2-8322-0331-6).
Based on the defined transition period of the Amendment 1:2012, Notified Bodies cannot doubt the manufacturers’ risk management system, if Amendment 1 has not been applied before December 31, 2017.
FOR OTHER COUNTRIES OR APPROVAL SCHEMES DIFFERENT TIMELINES FOR THE TRANSITION OF AMENDMENT 1:2012 APPLY. SOME EXAPLES:
USA FDA: Transition period for the A1 has already expired by August 1, 2016.
USA NRTL: Because the IEC 60601-1:2005 version has never been adapted by OSHA, the Amendment 1 version called “ANSI/AAMI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012” has to be used, alternatively the version based on the 2nd edition (UL 60601-1:2003) could currently still be used.
OUTLOOK ON FUTURE CHANGES
The Amendment 1 to IEC 60601-1 3rd edition was published as IEC version in July 2012. It includes 496 changes of the existing IEC 60601-1:2005 standard. The version from July 2012 (ISBN 978-2-83220-227-2) reflects solely the Amendment 1 changes. In August 2012, a consolidated version of IEC 60601-1:2005+A1:2012 (ISBN 978-2-8322-0331-6) was published. In this version the changes of Amendment 1 are incorporated in the main body of IEC 60601-1:2005, and are colored. The reader can easily distinguish between the requirements which remain unchanged and which have been changed due to the Amendment 1. The outlook for the future is, that an Amendment 2 is planned to be published in December 2019, and an entirely new edition of IEC 60601-1—the so-called 4th edition—is planned for December 2024.
IEC as standard organization does not define transition periods for certain countries or market regions. A standard is replaced at the date the next amendment or edition of the standard is published.
EUROPEAN MDD/CE PERSPECTIVE
Medical devices must comply with the essential requirements of the relevant European directives. Complying with standards (IEC, ISO, EN, etc., harmonized or non-harmonized) is not mandatory to show compliance with the essential requirements.
Manufacturers have to take into account the state of the art (SOTA) during the design and construction phase. Essential Requirement No. 2 requires that “the solutions adopted by the manufacturer for the design and construction of the device must conform to the safety principles, taking account of the generally acknowledged state of the art (SOTA)”.
During the following production phase, manufacturers have to take into account all changes in standards and scientific knowledge (SOTA) within the framework of their risk management system until no more new products are placed on the market. The risk management approach requires from manufacturers to recognize new international standards as part of new scientific knowledge. Every standard revision is the result of further development of the generally accepted state of the art. Manufacturers should therefore always start to deal with changed requirements as soon as possible.
As a minimum, manufacturers have to conduct a gap analysis if:
It is the responsibility of the manufacturer to provide safe medical devices (see 93/42/EEC, Annex I, Chapter 1, Essential Requirement No. 1). If a manufacturer fails to conduct a gap analysis of an applicable new IEC/ISO standard during the transition period, products might not be in compliance with the EC directives and their national laws in the member states—at least this manufacturer cannot show evidence that his products comply with Essential Requirement No. 1. This will certainly raise the manufacturer’s liability risks in cases of incidents.
Notified Bodies have to verify the risk management system of certified manufacturers. If a manufacturer is not able to furnish evidence that he has taken into account new standards and new scientific knowledge (e.g. by performing a gap analysis), he cannot prove compliance with Essential Requirement No. 1 described in Annex I, Chapter 1 of the MDD. This case needs to be judged as a minor nonconformity by the audit team.
If an applicable new IEC/ISO standard is ratified as EN standard and harmonized, i.e. listed in the valid Official Journal list (OJ list), then the transition period of the OJ list is generally accepted for the “Date of cessation of presumption of conformity of superseded standard”.
Note: The transition period does not depend on applicable particular standards. The EK-Med document 3.5 A1 (title: “Effect of Changed Standards and Scientific Knowledge on Manufacturers and Notified Bodies”) describes the common understanding of how manufacturers and Notified Bodies shall deal with changed standards and new scientific knowledge. If an applicable new IEC/ISO standard would not be harmonized, even then a general three-year transition period can be assumed, because almost all EN standards have been granted with a minimum three-year transition period by CENELEC and by the OJ list (EU Commission). This information might be important for IEC/ISO particular standards (IEC 60601-2-XX) which are not harmonized, and therefore the OJ list does not define a transition period for these IEC/ ISO particular standards.
In addition, it has to be emphasized, that full compliance with newer standards is not required by the Medical Device Directive. As long as the manufacturer can show objective evidence of compliance with Essential Requirements, e.g. by using technical solutions different to the proposed standard solutions, it is acceptable.