MAY • 2014 MEDICAL DEVICES NEWS MEDICAL DEVICES SINGLE AUDIT PROGRAM (MDSAP) 2 MEDICAL DEVICES ROUTE TO COMPLIANCE WITH ROHS 2 3 SGS MEDICAL DEVICES SERVICES PACKAGE RAISES INTEREST AT MEDICA 2013 4 SGS WEBINARS AND WHITEPAPERS: EXPLORE, INFORM AND DISCUSS 5 SPECIAL POINTS OF INTEREST: MEDICAL DEVICES NEWS MAY 2014 EDITORIAL Dear Reader, Welcome to our latest issue of our Medical Devices Newsletter. Within this issue, you will find the latest information on current MD developments, including: • Pilot programme for Medical Devices Single Audit Program (MDSAP) • Route to Compliance with RoHS 2 • SGS at MEDICA 2013 • Webinar and whitepaper update We hope you find this issue informative and useful. Best regards, SGS Medical Devices Expert Team
Transcript
LOREM IPSUMXXX
N° X • XXXXXXXX 2008XXX MAY • 2014MEDICAL DEVICES NEWS
MEDICAL DEVICES SINGLE AUDIT PROGRAM (MDSAP) 2
MEDICAL DEVICES ROUTE TO COMPLIANCE WITH ROHS 2 3
SGS MEDICAL DEVICES SERVICES PACKAGE RAISES INTEREST AT MEDICA 2013 4
SGS WEBINARS AND WHITEPAPERS: EXPLORE, INFORM AND DISCUSS 5
SPECIAL POINTS OF INTEREST:
MEDICAL DEVICES NEWS MAY 2014
EDITORIAL
Dear Reader,
Welcome to our latest issue of our Medical Devices Newsletter.
Within this issue, you will find the latest information on current MD developments, including:
• Pilot programme for Medical Devices Single Audit Program (MDSAP)
• Route to Compliance with RoHS 2
• SGS at MEDICA 2013
• Webinar and whitepaper update
We hope you find this issue informative and useful.
Best regards,
SGS Medical Devices Expert Team
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MEDICAL DEVICES SINGLE AUDIT PROGRAM (MDSAP)
MEDICAL DEVICES NEWS
Many customers of SGS will have seen in the medical device press the launch of MDSAP: a pilot scheme for joint audits covering the regulations of Australia, Brazil, Canada and USA, with the Japanese MHLW and PMDA as official observers. Links to press releases related to this scheme are shown at the end of this article. This scheme is only a pilot programme for the four regulatory authorities involved but will also be considered as a pilot for joint regulatory audits by the International Medical Device Regulators Forum (IMDRF) and all its members.
PILOT PROGRAMME EVALUATION
The pilot programme will last three years after which it will be evaluated, changed accordingly and then probably launched as a full-scale scheme for those regulatory authorities that wish to participate. The scheme does not cover the assessment of technical documentation.
In essence, participation by manufacturers in this pilot scheme will fully cover CMDCAS auditing requirements, be considered by TGA as meeting the QMS requirements, and be used by the FDA to replace routine inspections. ANVISA from Brazil have promised to consider the reports but currently there is no legislative framework to formally accept such reports in lieu of an ANVISA inspection.
MDSAP NOW ACCEPTING APPLICATIONS
To ensure the basis for the use of European harmonised standards and equivalent European docal documentation.
PILOT PHASE IS VOLUNTARY FOR MANUFACTURERS
The pilot phase is voluntary for manufacturers and it is expected that only those manufacturers already certified under the CMDCAS scheme will consider extending to MDSAP. Manufacturers who apply must submit
themselves to be audited against all of the four regulations (Note: exemption is made from regulations in markets where devices are not sold) and should expect the reports to be made available to all four regulatory authorities.
Audits are likely to be 35% to 100% longer than for existing CMDCAS audits. Manufacturers should also be aware that the GHTF five-category system of non-conformities is used, with the close out of the most serious category by unannounced audit.
However, participation in MDSAP may reduce the number of audits, and in particular postpone routine FDA inspections as well as replace a planned CMDCAS audit.
POSSIBILITY OF REPLACEMENT FOR 2015 CMDCAS WITH MDSAP
It is unlikely that SGS will offer MDSAP audits before the end of 2014. If manufacturers wish to replace a scheduled 2015 CMDCAS audit by a MDSAP audit they should contact their local SGS office and register an interest, as this will help us plan our implementation of MDSAP to better reflect our customers’ preferences.
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MEDICAL DEVICES ROUTE TO COMPLIANCE WITH ROHS 2
In May 2011, the European Union adopted new legislation concerning the Restriction of Hazardous Substances in Electrical and Electronic Equipment, RoHS 2 (2011/65/EU). This Directive replaces the previous RoHS Directive (2002/95/EC). Even though it doesn’t add new restricted substances, the Directive has a wider scope that impacts the documentation requirements and legal responsibilities of a larger number of businesses, from importers and distributors to manufacturers.
ADDITIONAL CATEGORIES TO INCLUDE MEDICAL DEVICES
RoHS 2 was implemented into national legislations by 2 January 2013. The number of categories of products covered by RoHS 2 has increased to 11, due to the inclusion of three new categories comprising of medical devices, monitoring and control instruments, and all other electrical and electronic equipment not covered by any other category. Therefore, these categories include products which were initially excluded, such as Medical Devices and In Vitro Medical Devices.
The list of RoHS 2 restricted hazardous substances with their respective maximum allowable concentration in homogeneous materials includes: Lead (Pb, 0,1%), Mercury (Hg, 0,1%), Cadmium (Cd, 0,01%), Hexavalent Chromium (Cr VI, 0,1%), Polybrominated Biphenyls (PBB, 0,1%), and Polybrominated Diphenyl Ethers (PBDE, 0,1%).
KEY IMPLICATIONS FOR MEDICAL DEVICES
Some of the medical devices now affected by RoHS 2 requirements include X-ray equipment, magnetic resonance imaging (MRI) equipment, portable emergency defibrillators, and computerised tomography machines.
Medical devices, such as MRI equipment and computerised tomography machines will need to demonstrate compliance with RoHS requirements starting on 22 July 2014, while In Vitro Medical Devices such as polymerase chain reaction (PCR) equipment have more time until 22 July 2017. Active Implantable Medical Devices are not included in RoHS 2. Only spare parts specifically manufactured
for the repair, the reuse, the updating of functionalities or upgrading of capacity, and already available on the market before the above-mentioned dates are exempt from compliance with RoHS 2.
MANUFACTURERS’ RESPONSIBILITIES
In addition to the impact of this new product category, RoHS 2 brings about a few other significant changes related to the broader scope of the Directive which has implications on the legal responsibilities of businesses.
Some of these changes affect manufacturers directly, as they are required to:
• Issue a signed Declaration of Conformity (DoC)
• Create a Technical Documentation File per the EN 50581:2012 or equivalent that meets requirements of module A of Annex II to decision 768/2008/EC
• Accept analytical material test results per the IEC 62321 Standard
• Keep the DoC and Technical Documentation File for a period of 10 years after the product has been placed on the market
• Obtain the CE marking, to prove RoHS 2 compliance
Since the CE marking now has a double function, manufacturers are required to comply with RoHS requirements not only in their technical documentation, but also on the EU DoC. In other words, the CE marking cannot be applied to the product until RoHS 2 compliance is demonstrated. In addition, the technical documentation must include among other things a conformity assessment, the use of standards, supplier declaration(s) of compliance, materials declarations, and results of any supplier audits as well as possible test results.
Businesses that were not part of the scope of the original Directive will now
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be faced with considerable burdens in creating and gathering the required documentation. On the other hand, manufacturers that are already in compliance with RoHS are affected by the application of the CE marking, which might involve additional testing and documentation. And since RoHS 2 conformity is not a one-time task, companies could face non-compliance consequences.
SGS MEDICAL DEVICES SERVICES CAN HELP
Whatever the challenge, the SGS Medical Devices team is able to provide expert support for RoHS 2 compliance. As part of SGS – the world’s leading verification, testing and certification company – we specialise in partial and complete testing of finished products,
and offer options for non-destructive testing.
Our RoHS related services for medical devices include:
• Ecodesign
• Energy Related Products (ErP)
• Full Product and Material Testing to IEC 62321 standards
• Process Gap Analysis and Consulting
• Product Risk Assessment
• REACH-Annex 17
• RoHS Certificate of Conformity
• REACH-SVHC
• Training
• Verification Services
• XRF Screening
FURTHER INFORMATION
For more information, please visit SGS Restricted Substances Services and SGS Medical Devices Services or Email Us.
To find out more about SGS RoHS2 services for medical devices, download our latest RoHS2 flyer on this topic.
SGS MEDICAL DEVICES SERVICES PACKAGE RAISES INTEREST AT MEDICA 2013
SGS’ renewed participation as an exhibitor at MEDICA 2013 raised considerable interest from an industry that’s adopting electro-medical technologies at an ever-increasing pace. MEDICA 2013 took place last November in Dusseldorf, Germany. An annual event that brings together all the relevant players in the global medical industry, last year it attracted 132 000 visitors, with more than half of those attending being international visitors (from 120 countries).
FOUR DAYS, 4 641 EXHIBITORS AND 115 000 M2 OF THE LATEST INNOVATIONS
Over four days, visitors to MEDICA 2013 were treated to an extensive program of conferences and forums, ranging from sports medicine to hospital management to disaster and military medicine. In addi-tion, a wide range of events highlighted new developments in medical tech, health IT, wireless, and wearable medical devices. These latest innovations in medi-cal products and services were show-cased by 4 641 exhibitors representing 66 nations in a 115 000 m2 arena.
HIGH INTEREST IN ELECTRO-MEDICAL DEVICES
Research numbers from MEDICA organisers1 reveal, as in previous years, more than half of all visitors were
specifically interested in the electro-medical and medical technology fields. The high interest in electro-medical devices prompted many visitors to enquire about SGS’ global portfolio of testing, certification, audit and training services. Exhibiting as part of the Association of British Healthcare Industries’ pavilion, our global team of medical devices experts were on hand to present the expanding range of SGS services to the international audience, such as our comprehensive product safety testing solutions for manufacturers of medical diagnostic X-ray devices. The SGS test report service received a lot of attention due to the way reports can act as global safety passports when placing electro-medical devices on the worldwide market.
SGS is the world’s leading inspection, verification, testing and certification com-pany. At events such as MEDICA 2013, and throughout the entire year, our global network allows our customers quick and direct access to SGS’ broad range of medical devices services and testing facilities. Our services for electro-medical devices are available in all manufacturing regions and close to all major medical markets.
Regardless of your project’s scope and target markets, SGS can improve the quality and efficiency of your electro-medical devices by combining in a one-stop package the advantages of worldwide reach, wide-ranging accreditations and multi-discipline expertise.
For more information on our services please visit SGS Medical Devices.
SGS WEBINARS AND WHITEPAPERS: EXPLORE, INFORM AND DISCUSS
SGS regularly hosts interactive webinars and publishes in-depth whitepapers that explore, inform and discuss key topics of interest in the medical devices industry. Make sure to join us online or download a copy of our latest whitepaper and keep up-to-date with the world’s leading inspection, verification, testing and certification company.
NEW WHITEPAPER LIBRARY
The improved SGS White Paper library provides a more user-friendly interface, allowing you to filter documents by date, topic or language. Related resources are also promoted to help you get a more comprehensive experience on your navigation.
Browse the new SGS whitepaper library here and explore the latest topics in the medical devices industry, such as how to gain market access in specific regions, and other key global markets, explained in our ‘Medical Device Regulations In The Main Global Markets’ whitepaper.
SGS WEBINARS
Access the Medical Devices webinar recordings anytime, anywhere.
FURTHER INFORMATION
Please visit the SGS Medical Devices website or contact us with any questions related to our webinars, white papers and upcoming events calendar.
MEDICAL DEVICE REGULATIONS IN THE MAIN GLOBAL MARKETS
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A SUMMARY OF THE MARKET ENTRY REGULATIONS FOR MEDICAL DEVICES IN THE THIRTEEN MAIN MARKETS
MEDICAL DEVICE REGULATIONS IN THE MAIN GLOBAL MARKETSMEDICAL DEVICE REGULATIONSIN THE MAIN GLOBAL MARKETS
