New RoHS directive (2011/65/EU): Now also the basis for the CE marking of medical devices

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1 TÜV SÜD I E-ssentials Medical Devices Technical industry e-news updates essential to your operations Editorial Dear Readers, Medical devices must meet stringent requirements all over the world. The key to success is in-depth familiarity with the approval and certification requirements of the individual countries. Given this, international manufacturers, distributors and retailers rely on TÜV SÜD s global expertise. Represented in over 40 countries of the world, TÜV SÜD keeps its finger on the pulse of today s technology, is familiar with national approval procedures and up-to-date with the latest news in this newsletter, we share our professional expertise with you. New RoHS directive (2011/65/EU): Now also the basis for the CE marking of medical devices This issue, for example, informs you about the revised procedure for the registration of Class A and B medical devices in Singapore which will come into effect on 1 January 2012 and bring in its wake a host of changes. What will be new in the certification process? Which deadlines will you have to observe? And what do you have to look out for? Find out the latest news in this newsletter. I hope you find our newsletter an interesting and informative read. Best regards, Dr. Peter Havel Senior Vice President, Medical & Health Services Global Contents New RoHS directive (2011/65/EU) 01 Approval requirements changed in Saudi Arabia 03 Import of medical devices to China 04 Approval of medical devices for the Korean market 05 Harmonized market approval in South East Asia 05 The Directive on the restriction of the use of certain hazardous substances in electrical and electronic equipment was revised as RoHS II (Restriction of Hazardous Substances). The most important change is that RoHS II now also applies to medical devices. Manufacturers and importers of medical devices should start at an early stage to address the provisions which now also apply to them, as these provisions form the basis for conformity marking (CE marking). On 1 July 2011, Directive 2011/65/EU was published in the Official Journal of the European Union. The new directive on the restriction of the use of certain hazardous substances in electrical and electronic equipment replaces the old Directive 2002/95/EC. The European Member States must transpose RoHS II into national law by 2 January License for Singapore required 06 Code of Conduct 07

2 Page 2 Key changes at a glance: no introduction of new restricted substances and no changes in maximum concentrations In spite of controversial discussions at European level, RoHS II introduces no new restricted substances and no changes in maximum concentrations. New category 11 Annex I was extended by category 11, which covers all electrical and electronic devices not yet assigned to any of the other categories. EU declaration of conformity and CE marking In accordance with RoHS II, manufacturers must issue an EU declaration of conformity as set forth in Annex VI and ensure CE marking of their products. However, the manufacturers of medical devices do not need to issue further or separate declarations of conformity. By issuing the declaration of conformity in accordance with the medical devices directive, manufacturers declare that their products comply with all applicable directives. Definition of homogeneous material One grey area fewer: in contrast to the former RoHS Directive, RoHS II provides a clear definition of the term homogeneous material : one material of uniform composition throughout or a material, consisting of a combination of materials, that cannot be disjointed or separated into different materials by mechanical actions such as unscrewing, cutting, crushing, grinding and abrasive processes. Hazardous substances Restricted and prohibited: Annex II defines the tolerated maximum concentration of six substances in homogeneous materials. The provision applies to: lead, mercury, cadmium, hexavalent chromium, polybrominated biphenyls (PBB) and polybrominated diphenyl ethers (PBDE). The exemptions for medical devices and their accessories are listed in Annex IV. Transitional periods After 1 July 2011, the European Member States must transpose RoHS II into national law within 18 months. The transitional period ends on 22 July 2014 for the manufacturers of medical devices, and on 22 July 2016 for in-vitro diagnostics. Not affected by the new directive are active implantable medical devices, which will not come up for renewed discussion until RoHS II is available for download at: RoHS II Torsten Zimmer torsten.zimmer@tuev-sued.de

3 Page 3 Approval requirements changed in Saudi Arabia New requirements for product certification mean that manufacturers need to act quickly 2. Medical Device Marketing Authorization (MDMA) The MDIR, and specifically the directive MDS-IR6, define which documents the manufacturers must submit to gain market approval for their products. To simplify the process, the documents are submitted electronically and saved in the MDMA database. Information on the manufacturer, product and regulatory status is also saved there. The regulatory status is important because certification can only be successful if the product is already approved in one of the founding states of the Global Harmonization Task Force (GHTF). The founder members of the GHTF are Australia, Canada, the EU, Japan and the USA. Manufacturers of medical equipment need to act quickly if they want to continue selling their products in Saudi Arabia in the future. The approval requirements have changed, and manufacturers must now have their products certified in accordance with the new regulation - the Medical Device Interim Regulation (MDIR) from the Saudi Food & Drug Authority (SFDA) - for the market there. After August 14th 2011, products without this certification can be turned back at customs. From January 1st, 2012, the use of medical products without a Market Authorization certificate will no longer be permitted. Two steps to product certification The entire certification process occurs online. 1. Licencing an Authorised Representative The licencing process is defined in MDS-IR5. This directive further specifies and supplements the provisions in Chapter 6 of the MDIR. Foreign manufacturers must name an Authorised Representative who carries out the licencing process on their behalf. The role of the AR might be, for example, to open a branch of the company in Saudi Arabia or to take over a distributor. The manufacturer can select any AR of their choice, but he must be officially licenced by the SFDA in order to carry out product certification. You can view MDS-IR5 in full here You can find the application form for licencing Authorised Representatives here The SFDA checks the application for formal correctness, while the content is assessed by a Conformity Assessment Body (CAB) accredited by the SFDA, such as TÜV SÜD. TÜV SÜD assesses the documentation submitted by the AR on behalf of the SFDA and confirms that the products conform to the relevant sections of the MDIR. The assessment of the content is based on MDS-IR6, especially Chapter 2 Articles 5 to 8, in which the requirements for the technical documentation are broken down. For example, as well as information on the manufacturer and product, the following must also be documented: Separate evidence on the safe operation of products with an electrical connection Process description of the transportation, storage, commissioning and disposal of the products Information on the qualifications or training required to be able to operate the device flawlessly and safely Advertising and marketing materials used in KSA Declaration of conformity with the MDIR and the Interim Marketing Authorisation Regulation You can read the MDS-IR6 in full here You will find the application form for market approval of medical products in Saudi Arabia here Norbert Stuiber norbert.stuiber@tuev-sued.de

4 Page 4 Different from the rest of the world: The import of medical devices to China is subject to special rules and standards Manufacturers and importers planning on placing their medical devices on the Chinese market soon notice that the provisions there sometimes differ significantly from their European counterparts. The international CB scheme, for example, is invalid in China. The approval procedure itself also follows a different pattern. To make matters even more complex, some of the classification and test requirements also differ drastically from those in the rest of the world. Only Chinese standards count As China does not accept the international CB certificate for medical devices, manufacturers and importers must apply a special procedure to prove that their products are in compliance with the national standards. However, European manufacturers and importers may benefit from the fact that most Chinese standards were derived from ISO and IEC standards. Given this, many regulations are identical or at least similar. The Chinese GB :2007 standard, for example, corresponds to the IEC :1988 A1+A2:1995 standard. This considerably facilitates the approval of medical devices for the Chinese market and saves costs. 2. Center for Medical Device Evaluation (CMDE) The CMDE reviews the technical files and design dossiers of the medical devices to be imported. The review results are documented in an expert report and form the basis for the licence issued by the SFDA. 3. Medical Device Testing Center (MDTC) The MDTC carries out type examination of the respective medical device. The type examination certificate is a prerequisite for the issue of a licence by the SFDA. Rapid market approval but how? The manufacturers and importers of medical devices intent on placing their products quickly and successfully on the Chinese market should have in-depth familiarity with the SFDA regulations. This applies to both the approval process and compliance with the standards. TÜV SÜD is on the spot and knows the regulations and processes, benefiting manufacturers an importers. TÜV SÜD s services extend from expert consulting to support, from planning to approval. Who tests what? In China, the approval of imported medical devices for the Chinese market falls under the responsibility of the following three authorities: 1. State Food and Drug Administration (SFDA) The SFDA is the supreme regulatory body and fulfils the following functions: It is firstly responsible for the development of standards and for the accreditation of the MDTCs (Medical Device Testing Centers). Secondly, the SFDA is the competent administrative authority, issuing the licences for market approval. However, to obtain a licence manufacturers or importers need a positive expert report issued by the CMDE (Center for Medical Device Evaluation) and the MDTC. Good communication with the SFDA is another aspect that should not be underestimated. As a CMDE/MDTC accredited by the SFDA, TÜV SÜD enjoys the confidence of the SFDA. And, last but not least, the independent experts know what is important and what to watch out for. Yijun Hua yijun.hua@tuv-sud.cn

5 Page 5 Approval of medical devices for the Korean market Effective immediately, TÜV SÜD can now also offer approval of Class II medical devices for the Korean market to manufacturers and importers. TÜV SÜD now holds accreditation by the competent authority, the Korea Food and Drug Administration (KFDA), and can therefore offer review of the required technical file. This accreditation adds a further location to the impartial third-party service provider s extensive portfolio of international approval services for medical devices. The accreditation is initially limited to a selection of Class II medical devices. At present, TÜV SÜD reviews the technical files of 100 products, including catheters, intravenous drip and blood donation systems. However, extension of the accreditation to cover all Class II medical devices is planned in the course of We will keep you posted on this issue. You can find a list of all medical devices tested by TÜV SÜD Korea here Hye-Jeong Sohn mhs_enquiry@tuv-sud.kr Harmonized market approval in South East Asia Standardized requirements for medical devices from 2014 onwards ASEAN (the Association of Southeast Asian Nations) strives to establish a harmonized approval procedure for medical devices throughout its ten member states. Recently, for example, the ASEAN members agreed to add an updated version of the CSDT (Common Submission Dossier Template) to the ASEAN Medical Device Directive (AMDD). At their meeting from 25 to 29 April 2011 in Cambodia, the participants decided to continuously improve the currently valid transitional directives. In addition, the updated CSDT is also an integral element of the final version of the new harmonized ASEAN directives for medical devices. The administrative directives will presumably be passed in the third quarter of 2011 and then phased in over a period of three to six months. Introduction of the new AMDD is to be completed by The AMDD will govern the basic safety and operational requirements and the classification of medical devices. In addition, the AMDD will provide for the establishment of an ASEAN-wide post-marketing alert system providing for observation of the market and reporting of inconsistencies. Most recently, the AMDD was extended with the addition of the CSDT for medical devices. The CSDT defines the technical data which must be submitted for medical device registration. In the future, market approval will be handled uniformly throughout all ASEAN member states. Given this, the CSDT will be effective in all ten member states from 2014 onwards, enabling market approval by filing the same dossier throughout all ASEAN member states. Manufacturers and importers must also provide a declaration of conformity, confirming that their products meet the requirements of the ASEAN Essential Principles of Safety and Performance. Paul Tan +65 Paul.TAN@tuv-sud-psb.sg

6 Page 6 Cutoff date 1 January 2012: Sale of Class A and B medical devices in Singapore only with license Distributors beware: while the above exemptions do not require product registration, distributors still need to obtain a dealer s licence. Furthermore, products falling under this exemption still require GDPMDS (Good Distribution Practice for Medical Device in Singapore) certification. Class B medical devices To be included on the T-List and the SMDR, Class B devices must meet the following criteria: From 1 January 2012 onwards, manufacturers, importers, retailers and distributors of Class A and B medical devices may only place products licensed by the Health Science Authority (HSA) on the Singapore market. The licensing procedure at a glance First, manufacturers and importers must create an online account at MEDICS. After successful online registration of the products, the medical devices are included in Transition Lists (T-Lists) for each class. The HSA reviews whether the registration meets the formal requirements. As a certified Conformity Assessment Body (CAB), TÜV SÜD reviews the technical files for compliance with the standards of the HSA. If the devices fulfil the formal and content-related criteria they are licensed. Medical devices that are approved for the market are listed on the Singapore Medical Device Register (SMDR). From 1 January 2012 onwards only devices included on one of the two lists can be imported and used, i.e. devices must at least have been registered. They must be Class B medical devices The application for registration must be submitted before the deadline. Otherwise longer processing periods must be expected. The abridged evaluation route is only open to products that have already obtained market approval for another country. The device may not fall into one of the following categories: eye lubricant, dialysate concentrate for haemodialysis, solution/irrigating/ non-injectable. What else is new? Applicants must make sure that the risk class is correct. An incorrect risk class is a reason for rejection of the application, resulting in additional costs and significantly longer processing times. The submission of applications through MEDICS has also been changed. The system now automatically identifies technical or administrative change. Furthermore, additional documents can now be uploaded in a targeted manner and attached to the selected device listing. The submission of multiple changes in one application is now also possible. For information about the revised approval procedure go to: What is new? The registration procedure for Class A and B medical devices has changed in many aspects. The key changes are summarized below. Exemptions for Class A devices Class A exempted medical devices which do not require product registration are included in GN 22 Guidance to the List of Medical Devices Exempted from Product Registration. They include, but are not limited to, mechanical stethoscopes, non-sterile cotton balls, walking sticks and ankle braces. Paul Tan +65 Paul.TAN@tuv-sud-psb.sg

7 Page 7 Eleven Notified Bodies signed Code of Conduct A first group of Notified Bodies has signed the voluntary Code of Conduct for Medical Device Notified Bodies. The Code of Conduct is an initiative to improve harmonised implementation of the European directives, creating a more level playing field for manufacturers. The initiative of this NB Plus Group has received strong support from various stakeholders. As a voluntary initiative the Code of Conduct aims at establishing a uniform basis for the assessment, surveillance and certification of medical device manufacturers and medical devices under the European directives MDD and AIMD. The General Statement and the General Principles specify criteria such as the qualification and experience of assessment personnel and the minimum time required for various conformity assessment processes. The signatories of the Code of Conduct express the necessity of strict and uniform quality control of the Notified Bodies in the Medical Device sector. Through voluntary harmonisation, they support the European legislative framework on an operational level, to improve consistency of conformity assessment operation hence creating a more level playing field for manufacturers and increasing trust in the European regulatory system for medical devices. The NB Plus group includes BSI, Hemel Hempstead, UK NB number 0086, DEKRA Certification GmbH, Stuttgart, Germany NB number 0124, DEKRA Certification B.V., formerly KEMA Quality BV, Arnhem, Netherlands NB number 0344, EUROCAT, Darmstadt, Germany NB number 0535, LGA Intercert, Nuremberg, Germany NB number 1275, LNE / G-MED, Paris, France NB number 0459, SGS United Kingdom Limited, Weston-super-Mare, UK NB number 0120, SNCH, Luxembourg NB number 0499, Szutest, Istanbul, Turkey NB number 2195, TÜV Rheinland LGA Products GmbH, Nuremberg, Germany NB number 0197, TÜV SÜD Product Service, Munich, Germany NB number After signing the Code of Conduct, the NB Plus Group commits itself to continuous improvement processes, especially the extension of the Code of Conduct to topics including clinical evaluation, IVD and Type Examination and the creation of a voluntary enforcement mechanism among the signatories. The NB Plus Group invites other Notified Bodies to join the Code of Conduct and to work together on further harmonisation. A copy of the Code of Conduct can be obtained from any of the participating Notified Bodies. In 2009, BSI, DEKRA, LNE/G-MED, TÜV Rheinland and TÜV SÜD started an initiative to create a Code of Conduct for the operation of medical device Notified Bodies. This group previously named NB5 subsequently involved further Notified Bodies in the drafting process and sought view from other stakeholders. The Code of Conduct can be downloaded here: Your Medical Device Contacts Worldwide Germany TÜV SÜD Product Service GmbH Ridlerstrasse Munich Italy TÜV Italy S.r.l. Via Isonzo, Casalecchio di Reno (BO) United Kingdom TÜV Product Service Ltd. Octagon House, Concorde Way Segensworth North Fareham Hampshire PO15 5RL USA TÜV SÜD America 10 Centennial Drive Peabody, MA Asia-Pacific TÜV SÜD PSB Singapore 1 Science Park Drive Singapore DISCLAIMER All reasonable measures have been taken to ensure the quality, reliability, and accuracy of the information in this newsletter. However, TÜV SÜD is not responsible for the third party content contained invthis newsletter. TÜV SÜD makes no warranties or representations, expressed or implied, as to the accuracy or completeness of information contained in this newsletter. This newsletter is intended to provide general information on a particular subject or subjects and is not an exhaustive treatment of such subject (s). Accordingly, the information in this newsletter is not intended to constitute consulting or professional advice or services. If you are seeking advice on any matters relating to information in this newsletter, you should where appropriate us directly with your specific query or seek advice from qualified professional people. The information contained in this newsletter may not be copied, quoted, or referred to in any other publication or materials without the prior written consent of TÜV SÜD. All rights reserved 2011 TÜV SÜD. Medical Devices Technical industry e-news updates essential to your operations Retail Technical industry e-news updates essential to your operations