LOREM IPSUM XXX MEDICAL DEVICES NEWS OCTOBER 2012 SPECIAL POINTS OF INTEREST: XXX EDITORIAL

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1 LOREM IPSUM MEDICAL DEVICES NEWS OCTOBER 2012 XXX XXX MEDICAL DEVICES NEWS N X XXXXXXXX OCTOBER 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: Saudi Arabia Enforcement Program for Medical Devices The Amendment 1 (A1) to Medical Equipment Basic Standard New Webinar: Preparing for the New Changes in Notified Body Audits and Technical File Reviews Medical Devices e-subscriptions page on the new enhanced We hope you find this issue informative and useful! Best regards, SGS Medical Devices Expert Team SPECIAL POINTS OF INTEREST: SAUDI ARABIA ENFORCEMENT PROGRAM FOR MEDICAL DEVICES PAGE 02 THE AMENDMENT 1 (A1) TO MEDICAL EQUIPMENT BASIC STANDARD PAGE 03 WEBINAR: PREPARING FOR THE NEW CHANGES IN NOTIFIED BODY AUDITS & TECHNICAL FILE REVIEWS PAGE 05

2 N X XXXXXXXX OCTOBER P. 2 SAUDI ARABIA ENFORCEMENT PROGRAM FOR MEDICAL DEVICES The Saudi Food and Drugs Authority (SFDA) is to start the Medical Device Marketing Authorisation (MDMA) Enforcement Project that will enforce the closure of ports to all medical devices (including in vitro diagnostic and active implantable devices) that do not have or have not applied for a MDMA Licence. THE CHANGES The SFDA and local regulations have specified for several years that all medical devices supplied to the Kingdom of Saudi Arabia must have a MDMA licence. Exceptions have been made during the initial part of the regulation on the market to provide time for manufacturers to address the requirements. As the next step in the regulation of Medical Devices, the SFDA isinitiating a phased implementation of enforcement by closing the ports to products without a MDMA licence or a MDMA licence application in progress. The initial phase will start in October 2012 with High Risk in vitro diagnostic medical devices(ivd). In the next phases this will be extended to medium risk IVDs and high risk medical devices. This means that from 1 October 2012, any High Risk IVD supplied to the Kingdom of Saudi Arabia must have a MDMA licence or have initiated the MDMA licence process (i.e. paid and applied for the licence which includes the submission of relevant documentation). Otherwise, it will not be permitted entry into the kingdom. The enforcement program will then be in phases over time to cover all types of medical devices. All manufacturers who supply medical devices of all types into the Kingdom of Saudi Arabia need to be aware of this development and to take appropriate steps to ensure they have a MDMA licence or have applied for a licence for their products requiring entry into the Saudi Arabian Market. Although the SFDA has ensured adequate resources for reviewing applications, it is still recommended that manufacturers do not delay their applications. SFDA REGULATIONS The SFDA has implemented a range of Regulations and Guidance documents for the regulation of Medical Devices within the Kingdom of Saudi Arabia. These documents can be found on the SFDA Website ( En/MedicalEquipments/Topics/interim+E. htm) MAIN FEATURES OF SFDA REGULATIONS All medical devices supplied into the Kingdom of Saudi Arabia must already meet the requirements of one of the GHTF Member States i.e. EU, US, Canada, Australia and Japan. In addition to the product being registered in one of the member states there are additional requirements designated by the SFDA in relation to local Environmental conditions, power supply, etc. as defined in the SFDA Implementation Rules. The SFDA works with five Conformity Assessment Bodies, of which SGS is one, in the review of applications for the MDMA licence but all communications go through the SFDA. All applications for licences must go through a licensed Authorised Representative in the Kingdom of Saudi Arabia.

3 N X XXXXXXXX OCTOBER P. 3 THE AMENDMENT 1 (A1) TO MEDICAL EQUIPMENT BASIC STANDARD The third edition of standard IEC : General Requirements to Basic Safety and Essential Performance was published in Experience soon proved that the 3rd edition of the basic standard required corrections. IEC have recently published the Amendment 1 on July 13, 2012, with EN standard ratification from CENELEC soon following on October 1, A1: THE MOST IMPORTANT CHANGES A1 contains 496 separate changes to the third edition, although most are only editorial corrections or clarifications. However, 83 of the changes have been assessed as having a moderate or significant impact on the users of the standard and the most important changes include: In IEC :2005 many of the normative references pointed to outdated references. A1 now updates these, for example, risk management according to ISO 14971:2001 has now been replaced by ISO 14971:2007. The third edition of standard IEC was a radical departure from tradition. Instead of focusing on a number of tests as a proof of safety, it introduced a process-based approach. Many people got the impression that the processbased approach had gone into overdrive: when it was hard to define a meaningful safety test, the standard relied on the phrase, compliance is checked by inspection of risk management file. As it is not possible to find all single fault cases in testing, it was put up to the manufacturers themselves to establish the processes of product development and risk management to capture and prevent possible sources of hazard. New problems were generated: Some of the tests involved in the third edition were excessive, some of the requirements unclear and the risk management approach over-employed. These issues were quickly realized when applying the standard. Work on the first amendment started back in On completion, A1 received a unanimous vote and has now beenwas published by the IEC on July 13, 2012, with CENELEC ratification as an EN standard following on October 1, The definition and rationale of both Essential Performance and Expected Service Life has now been completely rewritten. This has been done with the intention not to change the concepts but to make them easier to understand and apply. Subclause 4.2 for risk management and the related rationale has been almost completely rewritten. The description of the risk management process is now much more detailed and sets out the process requirements in compliance with ISO (with the exception that production, post-production monitoring and periodic reviews of the suitability of the risk management process are not required).

4 N X XXXXXXXX OCTOBER P. 4 IMPACT OF A1 ON TESTING, DOCUMENTATION AND CERTIFICATION In addition to the restructured risk management process description, A1 now relies less on inspection of risk management file. Instead it implements many specific subclauses for tests or requirements for technical documentation. Manufacturers need now to provide significantly more information to the user. A1 makes it mandatory that device labels additionally include: The contact information of the manufacturer The serial number, lot or batch information The date of manufacture or use by date Technical information also needs to include what is the essential performance and how and when it should be tested. Many of the electrical and mechanical tests have been re-defined to be less ambiguous to ensure that pass/ fail criteria are less dependent on interpretation. These are welcome changes that introduce, for example, redefined tests for movement over a more realistic threshold: ie the height of the threshold has been reduced to 10 mm with rounded edges: If the manufacturer has not defined the method to pass the obstruction, equipment will be run to it at a speed of 0.8 m/s. The IECEE organization operates the medical standards and CB system and it has already recognized the amended standard. While there is, as yet, no test report form available for the amended standard, it is possible to test and certify against it. But when it comes to harmonized standards within the EU system, the situation gets murkier. The European Commission has already made clear its dissatisfaction with CENELEC harmonized standards: especially the linking between the clauses of the standard and the essential requirements of the directives. In principle, this issue has been settled, however, for some time now the new harmonized medical standards have not been listed in the Official Journal of the EU. As a result, it is more complicated to use them for presumption of compliance. The US and Canada are moving forwards with the introduction of the A1 and it is expected that ANSI/AAMI and CSA will publish the amendment soon. IMPORTANT ADVICE TO USERS OF THE STANDARD It is recommended to purchase the IEC standard edition 3.1 from the IEC web store now and take advantage of its clear outline of all the changes of Amendment 1, which are marked up in red. This document will help you tremendously to find out what has changed!

5 N X XXXXXXXX OCTOBER P. 5 WATCH THE COMPLIMENTARY WEBINAR PREPARING FOR THE NEW CHANGES IN NOTIFIED BODY AUDITS AND TECHNICAL FILE REVIEWS at medical device manufacturers and organizations who have certification under one of the European medical device directives or who plan to obtain such certification. The relevant directives are Active Implantable Medical Devices, 93/42/EEC Medical devices and 98/79/EC In Vitro Diagnostic Medical Devices. Those people involved with or responsible for quality systems, regulatory affairs, product design, manufacture or clinical activities will find the subject relevant. PRESENTER Mr. Chris Jepson BSc., FCQI, MIMMM, C Eng SGS Global Manager- Medical Devices Language: English Event location: Online Cost: No Charge For more information, please contact: Chris Jepson via (medicaldevices@sgs.com) The webinar recording is available at: sgseventcenter/lsr.php?at=pb&sp=ec &rid= &rkey=2c60c91e80f6 FC82 Watch the 45-minute complimentary webinar Preparing for the New Changes in Notified Body Audits and Technical File Reviews conducted last 23 October The objective of this 45-minute complimentary webinar is to inform manufacturers of the likely changes they will start to experience in audits and technical documentation reviews from Notified Bodies. These changes are starting to occur now and will continue to be introduced during AGENDA Why is Change Needed? Where and How are these Changes being Agreed? Changes to Audits and Actions for Manufacturers Changes to Technical File Reviews and Actions for Manufacturers Opportunity for Question and Answers TARGET AUDIENCE This complimentary webinar is aimed

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