JANUARY • 2013 MEDICAL DEVICES NEWS APPLICATION OF EUROPEAN HARMONISED STANDARDS 2 IMDRF - THE NEW GLOBAL HARMONISATION ORGANISATION 5 COLLATERAL MEDICAL STANDARDS IN THE CB SCHEME 6 IMPORTANCE OF ‘MEDICAL PURPOSE’ 8 GUIDANCE FOR SAUDI ARABIAN MARKET AUTHORISATION APPLICATIONS 9 SGS MEDICAL DEVICES SYMPOSIA 2013 10 SPECIAL POINTS OF INTEREST: MEDICAL DEVICES NEWS JANUARY 2013 EDITORIAL Dear Reader, Welcome to the latest issue of our Medical Devices Newsletter. Within this issue you will find the latest information on current MD issues, including: • The role that harmonised standards play in demonstrating compliance with the requirements of EC Medical Device Directives • The new global harmonisation organisation - the International Medical Device Regulators Forum (IMDRF) • The collateral medical standards in the CB scheme • The importance of ‘medical purpose’ and when it needs to be stated for products to be covered by the European medical device directives • Guidance for Saudi Arabian market authorization applications • The SGS Medical Devices Symposia in Korea, Japan and Taiwan We hope you find this issue informative and useful! Best regards, SGS Medical Devices Expert Team
Transcript
LOREM IPSUMXXX
N° X • XXXXXXXX 2008XXX JANUARY • 2013MEDICAL DEVICES NEWS
APPLICATION OF EUROPEAN HARMONISED STANDARDS 2
IMDRF - THE NEW GLOBAL HARMONISATION ORGANISATION 5
COLLATERAL MEDICAL STANDARDS IN THE CB SCHEME 6
IMPORTANCE OF ‘MEDICAL PURPOSE’ 8
GUIDANCE FOR SAUDI ARABIAN MARKET AUTHORISATION APPLICATIONS 9
SGS MEDICAL DEVICES SYMPOSIA 2013 10
SPECIAL POINTS OF INTEREST:
MEDICAL DEVICES NEWS JANUARY 2013
EDITORIAL
Dear Reader,
Welcome to the latest issue of our Medical Devices Newsletter.
Within this issue you will find the latest information on current MD issues, including:
• The role that harmonised standards play in demonstrating compliance with the requirements of EC Medical Device Directives
• The new global harmonisation organisation - the International Medical Device Regulators Forum (IMDRF)
• The collateral medical standards in the CB scheme
• The importance of ‘medical purpose’ and when it needs to be stated for products to be covered by the European medical device directives
• Guidance for Saudi Arabian market authorization applications
• The SGS Medical Devices Symposia in Korea, Japan and Taiwan
We hope you find this issue informative and useful!
Best regards,
SGS Medical Devices Expert Team
P. 2N° X • XXXXXXXX 2008XXX P. 2JANUARY • 2013
APPLICATION OF EUROPEAN HARMONISED STANDARDS
MEDICAL DEVICES NEWS
The role that harmonised standards play in demonstrating compliance with the requirements of EC Medical Device Directives is highlighted in this article. The article outlines the legal and practical implications for manufacturers.
INTRODUCTION
The use of harmonised standards in the conformity assessment process leading to CE marking of medical devices and in vitro diagnostic medical devices has been given recent prominence by a number of relatively high profile challenges from both manufacturers and the European Commission (EC). These challenges have involved a range of standards including EN 60601-1:2006 Media discussion on the topic has generated some confusion on the issues. This article seeks to set out a more objective analysis of the situation and highlight that in fact, nothing has changed.
DIRECTIVE REFERENCES
To ensure the basis for the use of European harmonised standards and equivalent European documents is understood, it is worthwhile to first review the major references in the two directives under discussion. It can be considered that the approach taken in the Active Implantable Medical Device Directive is completely analogous to Directive 93/42/EEC for Medical Devices, and that the In Vitro Diagnostic Medical Device Directive 98/79/EC has equivalent wording but with the additions as stated below:
• Directive 93/42/EEC Article 3 states: ‘The devices must meet the Essential Requirements set out in Annex I which apply to them, taking account of the intended purpose of the devices concerned.’ This represents the fundamental and overriding principle of CE conformity and applies in particular to the first clause of Essential Requirement 2.
• Essential Requirement 2 states: ‘The solutions adopted by the manufacturer for the design and construction of the devices must conform to safety principles, taking account of the generally acknowledged state-of-the-art.’ This means documents and standards that are safety related, relevant to the intended purpose and considered state-of-the-art must be taken into account and solutions adopted that are identical or conform to the same safety principles.
• Directive 93/42/EEC Article 5 states: ‘Member States shall presume compliance with the Essential Requirements referred to in Article 3 in respect of the devices which are in conformity with the relevant national standards adopted pursuant to the harmonised standards the references of which have been published in the Official Journal of the European Communities.’ The Directive additionally describes some cases where the European Pharmacopoeia may be seen as equivalent to harmonised standards.
• Directive 98/79/EC additionally states in Article 5: ‘Member States shall presume compliance with the Essential Requirements referred to in Article 3 in respect of devices designed and manufactured in conformity with common technical specifications drawn up for the devices in List A if Annex II and, where necessary, the devices in List B of Annex II. […] Manufacturers shall as a general rule be required to comply with the common technical specifications; if for duly justified reasons manufacturers do not comply with those specifications they must adopt solutions of a level at least equivalent thereto.’
Unlike some other regulatory jurisdictions European Medical Device Directives do not make the use of specific standards mandatory, with the exception of the use of common technical specifications for certain IVD devices.
P. 3N° X • XXXXXXXX 2008XXX P. 3JANUARY • 2013MEDICAL DEVICES NEWS
HARMONISED STANDARDS AND ANNEX Z
It is the policy of the European standards bodies CEN and CENELEC to adopt international ISO and IEC standards where possible and so most harmonised standards are dual ISO or IEC standards. All harmonised standards will contain an Annex Z for each EC Directive under which they are harmonised and, in this respect, they are not identical to the ISO or IEC version.
Annex Z is in the form of a table correlating the requirements in the standard with the Essential Requirements where compliance can be presumed. Manufacturers cannot use harmonised standards to claim compliance using a presumption of conformity where no such correlation is shown in Annex Z. Unfortunately, in the last few years many of the Annex Zs have been shown to be inaccurate or over simplistic indicating a degree of correlation which cannot be justified.
CEN and CENELEC are in the process of reviewing the standards and reissuing them with more accurate Annex Zs. Most EN standards published since the beginning of 2012 will have accurate and more detailed Annex Zs, and these can be relied on by manufacturers to indicate precisely the Essential Requirements where compliance can be presumed. Earlier dated standards are still valuable but the extent of the compliance may be exaggerated and further justification of compliance with indicated Essential Requirements may be required.
It should be noted that very few harmonised standards can be considered a presumption of compliance with all the essential requirements, so harmonised standards should be seen by manufacturers as just part of the requirements to be met for CE marking. Where the harmonised standard is an EN
ISO standard the requirements will be identical to the ISO version, but without knowledge of the contents of the Annex Z manufacturers will not be able to make precise claims of a presumption of conformity in their technical documentation.
NEW OR REVISED HARMONISED STANDARDS
Some of the recent media discussion has indicated that Europe operates a system of product grandfathering, whereby designs already approved and in compliance with previous standards or previous versions of standards are exempt from further testing. This is not the system adopted by Europe. While it is true that devices already physically placed on the market are not affected by new or changed standards, unless they have been shown to be unsafe, all products at the time of being placed on the market must meet all Essential Requirements (including Essential Requirement 2). As a result, manufacturers must take account of the current state-of-the-art with respect to safety, which may now be represented by the new or changed standard.
When a harmonised standard is revised or is replaced there is a ‘date of cessation of presumption of conformity of the superseded standard’, which is an important date for all manufacturers who have used the superseded standard as a presumption of conformity. This date is when their previous justifications become invalid and without review or retesting their technical file will not adequately demonstrate conformity to the Essential Requirements.
In practice, a revised standard may not require full device retesting or process revalidation, this is because many standard revisions are only
partial revisions. An approach for some manufacturers is to undertake a gap analysis between the obsolete version and the revised harmonised standard. If this documented analysis shows that the changes in the standard are not relevant to the device in question, or could have no effect upon their device, then retesting to the new standard is not required. Alternatively, and more commonly, this analysis could demonstrate that only partial retesting is required (this may be appropriate for some devices in relation to EN 60601-1). This fully documented analysis and rationale must form part of the technical file for the device.
OPTIONS FOR THE USE OF HARMONISED STANDARDS
Many harmonised standards represent the state-of-the-art or the international benchmark for safety, and in some cases for performance, and the market will have expectations of conformance. Therefore conformance to the appropriate harmonised standards, unless they have been generally judged inadequate, is for most manufacturers the easiest, clearest and in many cases the cheapest approach. The exception would be for innovative products for which the standards cannot meaningfully be applied. In these cases, the manufacturer is required to demonstrate conformance directly against the Essential Requirements. This normally involves extensive documentation and a lengthy review by the Notified Body against the basic principles of the Essential Requirements.
Where a manufacturer has chosen not to apply a harmonised standard (generally acknowledged to be state-of-the-art) for a safety aspect then this approach is acceptable. However, once
P. 4N° X • XXXXXXXX 2008XXX P. 4JANUARY • 2013MEDICAL DEVICES NEWS
again this normally involves extensive documentation and a lengthy review by the Notified Body against the basic principles of the Essential Requirements. The documentation must contain justification that equivalence to the safety principles of the harmonised standard has been demonstrated or that the safety principles cannot be applied to this type of device Where the harmonised standard contains non-safety related performance criteria, manufacturers have more flexibility to justify their non-application for the intended use; as harmonised standards are not mandatory and state-of-the-art applies to safety aspects only. For most manufacturers, the market expects conformance to standard performance criteria and so deviations should be considered only in exceptional circumstances, and where a definite benefit to risk ratio can be demonstrated.
Common technical standards, where they exist, for IVD devices fall into a different category and in effect must be applied.
CONCLUSIONS
All manufacturers should be aware of the current and imminent harmonised standards for devices they wish to place on the European market. These must be considered as one of the design inputs and references in their technical documentation. For the majority of devices and manufacturers, conformance to the appropriate harmonised standards is a cost-effective approach to conformity assessment and the European market, and conformance is encouraged.
Manufacturers should be aware that harmonised standards do not cover all aspects of a device. They can sometimes be behind the state-of-the-art, meaning manufacturers should be aware of all other standards, guidance and documents that are acknowledged to represent the state-of-the-art with respect to safety and performance. These also need be used as a means of demonstrating compliance to the Essential Requirements.
Europe wishes to encourage innovation
and novel medical devices and so harmonised standards are not mandatory, with the exception of common technical specifications and those related to colour coding and symbols where deviations would be immediately dangerous. In the cases where harmonised standards are not used, manufacturers should expect to document the justification and data on which judgements are made to a high degree. This is because judgements will be examined and challenged by the Notified Body as no presumption of compliance can be assumed.
FURTHER INFORMATION
A list of current harmonised standards and their applicable dates can be found here: http://ec.europa.eu/enterprise/policies/european-standards/harmonised-standards/medical-devices/index_en.htm
For more than 20 years, the Global Harmonisation Task Force (GHTF) has promoted the international harmonisation of medical device regulation, involving key stakeholders from the national medical device regulatory authorities and the regulated industry. However, after a final conference meeting the GHTF website is now closed (as of November 2012) and web users can now only see a statement directing them to the organisation replacing the GHTF: the International Medical Device Regulators Forum (IMDRF). This article covers the replacement of the GHTF with the IMDRF and the current status of the international guidance documents that are recognised by most Regulatory Authorities.
TAKING UP THE CHALLENGE
The IMDRF was created in October 2011 with the explicit aim to direct and accelerate the convergence of international medical device regulations. In contrast to the GHTF, the participating members are now only the regulatory authorities. The GHTF established the basics of a model for medical device regulation that could be adopted by any regulatory region globally, and had some similarities to that in the EC Directives. The IMDRF aims to build upon this foundation but with the focus on critical regulatory practices that can be discussed specifically by the regulators.
The inaugural IMDRF chair and secretariat is Australia and the current members are: Australia, Brazil, Canada, Europe, Japan, and the USA. The membership of China and the Russian Federation is currently being confirmed. The World Health Organization (WHO) is an official observer while the Asian Harmonisation Working Party (AHWP) is an affiliate organisation.
Although IMDRF membership is restricted to regulators, a broader range of stakeholders are being included in working groups to develop existing GHTF documents and develop new IMDRF documents.
The next meeting of IMDRF will take place March 2013, in France. Details of the Stakeholder Session will be available on the IMDRF website in due course.
GUIDANCE DOCUMENTS: AN IMPORTANT RESOURCE
An important role of the IMDRF has been to develop a strategy for the management and maintenance of the previous GHTF documents. All current GHTF and new IMDRF documents are available on the IMDRF website, providing an important resource for manufacturers.
As a reminder, some of the most useful documents for manufacturers from GHTF include:
• SG1 Essential Principles of Safety and Performance of Medical Devices (GHTF/SG1/N68:2012)
• SG5 Clinical Evidence for IVD Medical Devices (GHTF/SG5/N6:2012)
• SG3 Quality Management System – Medical Devices – Guidance on the Control of Products and Services Obtained from Suppliers (GHTF/SG3/N17:2008)
• SG3 Quality Management Systems – Process Validation Guidance (GHTF/SG3/N99-10:2004)
New final documents from the IMDRF itself are currently limited to terms of reference and position statements, but working items have already been defined and progressed. In the near future, draft documents focussing on topics such as those below are expected from the IMDRF:
• Implementation of UDI system
• Medical Devices Single Audit Program
• Regulated Product Submission project
CONCLUSIONS
Guidance documents from IMDRF are going to continue to be an important resource for manufacturers who wish to understand and anticipate developing global regulatory requirements.
FURTHER INFORMATION
Current GHTF and IMDRF documents can be found on the IMDRF website:
COLLATERAL MEDICAL STANDARDS IN THE CB SCHEMEThe basic standard for all electrical medical equipment is IEC 60601-1. In addition, there are also multiple collateral standards, but it is not always clear what collateral standards apply and what testing and certification needs to be done. This article discusses the role of collateral standards in CB scheme.
ABOUT IECEE AND THE CB SCHEME
The CB Scheme is a multilateral global certification system, operated by the IEC System for Conformity Testing and Certification of Electrical Equipment (IECEE). Their objective is to create one global certification system in order to promote free trade and assist manufacturers to create safe and efficient equipment.
The CB Scheme should not be confused with the CE mark or other national regulatory approvals. For example, in Europe devices must meet the Essential Requirements. Some product classes require more extensive testing than CB Certification, others may require less testing. However, in many cases the Scheme is a useful starting point.
The basic idea behind the CB Scheme is to use the principle of mutual recognition for its national members. When a member of the Scheme in country A has certified electrotechnical equipment and components to meet requirements, there is no need to perform additional testing for the same equipment in country B. Member body of country B will issue a national certification mark for the equipment, based on the original
testing. The purpose of the Scheme is to unify requirements and simplify trade to participating countries.
Standards operated by IECEE are divided in 17 categories. We are going to discuss in more detail one of them: electrical equipment for medical use (MED).
IEC 60601-1: THE BASIC STANDARD AND COLLATERALS
The basic standard for all MED equipment is IEC 60601-1. There are two editions of it in common use: 2nd edition (1988-12) ‘Medical Electrical Equipment – Part 1: General Requirements for Safety’; and more recent is the 3rd edition (2005-12) ‘Medical Electrical Equipment – Part 1: General Requirements for Basic Safety and Essential Performance’. The 3rd edition has been strongly restructured and the basic concept has moved from ‘safety by type testing’ to ‘safety by risk management and testing’. Both editions have been amended since the original publication.
In Europe, USA and Canada the transition from 2nd edition to 3rd edition has already been accepted by the regulatory authorities, or is in the process of changing, but in other parts of the world,
for example in China and Japan, the 2nd edition is still in current use.
The basic standard has later been expanded with collateral standards, which apply to some subcategory or functionality of equipment. For example, IEC 60601-1-3 applies to radiation protection in diagnostic X-ray equipment. Just as the basic standard exists in two major editions, the collateral standards have editions that are specific to either 2nd edition or 3rd edition of the basic standard.
WHICH COLLATERALS ARE COMPULSORY TO BE TESTED ALONG WITH THE BASIC STANDARD?
For the CB Scheme there are practical considerations, which determine the applicable standards that need to be taken into account. For instance, ‘Is there added value for the manufacturer and customer?’ or ‘Are the test laboratories capable of addressing all the needs?’ In the IECEE CB Scheme, the Certification Management Committee (CMC) makes these decisions and in June 2012, they held a meeting to determine the ‘compulsory’ collaterals.
P. 7JANUARY • 2013MEDICAL DEVICES NEWS
In the table below the status of collaterals have been consolidated:
Table 1: Status of collateral standards in reference to basic standard testing and certification.
USE OF COLLATERAL STANDARDS IN THE IECEE CB SYSTEM
Standard Application
Edition of the collateral standard matching the corresponding basic standard edition Compulsory in CB test
report and certificate?60601-1 2nd Ed 60601-1 3rd Ed
ISO 10993-1 Biocompatibility ed3.0 (2003-09) 5) ed4.0 (2009-10) 6) No
Notes: 1) A separate test report and certificate possible2) Included in basic standard, requires additionally IEC 62304 ed1.0 (2006-05) SW life cycle process3) Requires additionally IEC 62366 ed1.0 (2007-1) Usability process. Some countries may require IEC 60601-1-6 ed2.0 (2006-12) instead4) Original conditional Yes proposal of CMC was reversed, based on email feedback5) Actually referenced in clause 48 Biocompatibility of the basic standard6) Actually referenced in sub-clause 11.7 Biocompatibility of ME Equipment and ME Systems of the basic standard
It is interesting that standard IEC 60601-1-6 ‘Usability’ was originally proposed to be a compulsory inclusion for the test report and certificate. However, the CMC meeting decided to take a two month timeout for the final decision. Based on the feedback received from members, it was later decided to be excluded from the list.
CONCLUSIONS
Table 1 contains consolidated information of what collaterals need to be included in a CB Scheme test report and certificate. However, local regulatory authorities may have different
requirements. For example, while the evaluation of usability is not compulsory in the CB Scheme, both Medical Device Directive in EU and FDA in USA require that the manufacturer has addressed risk of use errors (or human factors engineering) in the safe design of the equipment. It should also be noted that while exclusion is possible, inclusion may benefit the manufacturer more.
FURTHER INFORMATION
Full table for ‘Use of Standards’ in the IECEE system standards for edition 2 and 3 of the basic standard IEC 60601-1 can be found at:
A recent court ruling addressed the need for a stated medical purpose for a product to be covered by the European medical device directives. This article summarises for manufacturers the findings on this important concept.
COURT JUDGEMENT
On November 22, 2012, the European Court of Justice in the Case C-219/11 stated:
“The third indent of Article 1(2)(a) of Council Directive 93/42/EEC of 14 June 1993 concerning medical devices, as amended by Directive 2007/47/EC of the European Parliament and of the Council of 5 September 2007, must be interpreted as meaning that the concept of ‘medical device’ covers an object conceived by its manufacturer to be used for human beings for the purpose of investigation of a physiological process only if it is intended for a medical purpose.”
INTERPRETATION
The device subject to the court ruling was a device that investigated physiological processes by recording brain activity but for no specified medical purpose: it did not help the diagnosis of any medical condition and it did not treat any medical condition. So, the court deemed that this was not a medical device and did not fall under 93/42/EEC; even though similar products were marketed by different manufacturers as
diagnostic equipment and were subject to Directive 93/42/EEC. SGS considers the same principle would apply to products with no medical purpose but were similar to medical devices that treated a medical condition or were similar to an in vitro diagnostic medical device. An example of such a product with no medical purpose would be a product to measure heart rate for sports or fitness training purposes.Manufacturers should note that it is not possible to avoid EC medical device directives for products that will be used for medical purposes by an absence of a stated intended purpose. If manufacturers wish to place on the market devices with no intended medical purpose, then the instructions for use should clearly state the actual purpose and should make clear that the product is not to be used as a medical device.
CONCLUSIONS
This judgement confirms the current view of SGS and so no change is to be made on the way SGS interprets the directives.
GUIDANCE FOR SAUDI ARABIAN MARKET AUTHORISATION APPLICATIONS
Detailed Guidance is now available online for manufacturers wishing to sell devices in the Kingdom of Saudi Arabia. This article explains where to find the information online.
SAUDI ARABIAN MARKET AUTHORISATION APPLICATIONS
Currently, a large percentage of Saudi Arabian market authorisation applications are being rejected at the initial review, which is delaying the process for many manufacturers and their Authorised Representatives.
NEW GUIDANCE
The Saudi Authorities, the SFDA, have just published a document titled: ‘Guidance for Completing SFDA On-line MDMA Application Form – EU Jurisdiction’. This document is very useful to any manufacturer using European approvals or registrations (ie CE marking) as the route to obtain a Saudi Arabian market authorisation. A more detailed article on the medical device regulations that apply to the Kingdom of Saudi Arabia, and the use of customs to restrict the import of medical devices without a valid Medical Device Market Authorisation, appears in Issue 4 of the SGS Medical Devices Newsletter.
CONCLUSIONS
The document is based on real experience in reviewing applications and if used can speed up the process for manufacturers.
Our informative and interactive Medical Devices Symposia in Korea, Japan and Taiwan will review the key updates to the regulatory requirements of different markets, while giving you the opportunity to network with other medical devices sector professionals.
Our international team of medical devices experts will provide you with an informative and interactive review of the key updates to the regulatory requirements in different markets. Across the three symposia, which will be held in Korea, Taiwan and Japan, speakers will share their knowledge on market entry requirements, regulatory frameworks and the challenges faced by manufacturers and other organisations in the medical devices supply chain. Experts will address the needs of different global markets, looking at each country or region individually and in detail. Sharing their industry-wide experience, speakers will also cover associated and pertinent topics that present further challenges and opportunities in the industry today. Attending an SGS Medical Devices Symposium will also be a unique chance to network with other medical devices sector professionals.
SGS MEDICAL DEVICES SYMPOSIUM IN SEOUL, KOREA – MARCH 27 - 29, 2013
This three-day comprehensive symposium will look in-depth at the country or regional markets of: Russia; China; Saudi Arabia; the European Union; Japan; Brazil; the US and Canada; and Taiwan. The expert speakers will also discuss the recent activities of the Asian Harmonisation Working Party (AHWP) and International Medical Device Regulators Forum (IMDRF).
SGS MEDICAL DEVICES SYMPOSIUM IN YOKOHAMA, JAPAN – MARCH 26, 2013
The one-day event in Japan will be focused on the specific market regulatory requirement for the EU, Brazil, Korea and Taiwan.
SGS MEDICAL DEVICES SYMPOSIUM IN TAIPEI, TAIWAN – APRIL 1 - 2, 2013
During day one of this two-day symposium the focus is on the requirements of different country and regional markets, with speakers covering: the European Union; Brazil; the US and Canada; Korea; and Japan. Day two of this symposium takes a look at a further four important industry topics. Among these speakers will be discussing life-cycle management related to medical devices software and the introduction of the EN 62304, and the clinical evaluation of medical devices.
FURTHER INFORMATION
For more information about the symposium and to register please contact us using the links below:
Korea registration page: http://www.sgsgroup.kr/en/Sections/SGS-Medical-Devices-Symposium-2013-in-Korea.aspx
Japan registration page: http://www.sgsgroup.jp/en/Sections/SGS-Medical-Devices-Symposium-2013-in-Japan.aspx
