Free white paper that explains which documents to use and how to structure them. Some "associations" have drawn up proposals for the structure of the technical documentation to try to achieve the following objectives: One of the best known proposals for structuring technical documentation comes from the IMDRF (formerly the GHTF). Audit of QMS according to ISO 13485 and FDA QSR CFR 21 Part 820. At the conclusion of the audit, a decision should be made as to whether top management has demonstrated the necessary commitment to ensure a suitable and effective quality management system is in place and being maintained and whether the effectiveness of the system has been communicated to personnel. We expect that for the majority of products – in particular, the lower risk class products compliance may already be quite well established with the current information available for the MDD … The steps to approval are audit of the full quality assurance system and examination of the design by the European Notified Body examination and testing of the device. The Medical Device Directive – MDD – (Directive 93/42/EEC) was published in 1993. �����pz00�= +�f`j��B�G��30�`��V� �I2 Medical Device Directive 93 42 EEC MDD Annex IX Classification Criteria Information & Training. The MDR has put even more emphasis on requirements related to clinical aspects. Find out more! 1. However, their contents are nevertheless regularly requested during audits and reviews of the technical documentation. Essential Requirements Checklist Annex I of Proposed EU Regulations & Compromise Amendment for Medical Device CE Marking Identity of the device and applicable configurations/variants covered by this checklist: ! These publications have no legal force. The columns, which represent the structures named above, describe where in which file the content can be found. The proposal of the NB team set out in the document NB-MED 2.5/1 is also relevant in practice. This ASEAN CSDT is called “Guidance on Preparation of a Product Registration Submission for General Medical Devices using the ASEAN Common Submission Dossier Template”. The audit under the Medical Device Directive can be combined with the audit under the ISO 13485 standard. 2. NOTE: The audits that will be conducted include various applicable statutory and regulatory standards to avoid any oversight and lapses e.g. ��|�4n��!�-�g ��f& Time flies and, before you know it, the MDD will be no more. Slide 1 of 37 Robert Packard, Consultant www.MedicalDeviceAcademy.com rob@13485cert.com Medical Device Directive (MDD) 93/42/EEC as modified by 2007/47/EC For most manufacturers, the QM system is the prerequisite for the conformity assessment. Manufacturers are legally obliged to demonstrate compliance with these requirements. Preparation for unannounced audits: Unlike a regular audit, there won’t be an opportunity to specifically prepare for unannounced audits. Council Directive 93/42/EEC of 14 June 1993 concerning medical devices. You won’t find such granular requirements in the MDD, MDR, or ISO 13485. In Germany, the regulations of the National Medical Devices Act (MPG) should be applied to. Nevertheless, there are country-specific differences. The above regulations define the aspects that the technical documentation must contain. > Your checklist > Technical file. The new MDR provides an additional time after the date of application allowing to place new products under the MDD … However, it mentions: They must include, for example: All these documents must be submitted by manufacturers during the conformity assessment procedure - as technical documentation. Compliance Online medicaldeviceacademy.com. 5.3.3 M.R. mdd annex ii – ec declaration of conformity (Full Quality Assurance System) The EC declaration of conformity is the procedure whereby the manufacturer who fulfils the obligations imposed by Section 1 (of the Directive) ensures and declares that the products concerned meet the provisions of the Directive which apply to them. Document No: MDSAP AU P0002.005 Revision Date: 2020-09-01 . For development projects that are already in progress, the revised SPR checklist could be used for a gap assessment and considered together with the launch plan for the device to decide on the strategy to transition to the MDR. 1856 0 obj <>stream Fig. ... EU MDR Checklist of Mandatory Documents. Fig. 93/42/EEC (MDD) and the Active Implantable Medical Devices Directive 90/385/EEC (AIMDD). The IVDR will replace the existing In Vitro Diagnostic Medical Devices Directive (98/79/EC) (IVDD). An SPR checklist could then be used for new projects so that new devices are compliant with the SPRs in the MDR when they come out of the new product pipeline. A successful audit from SGS will ensure your products’ compliance and 93/42/EEC certification. For all Classes of medical devices (I, IIa, IIb, III) the manufacturer must have and keep up-to-date a technical documentation, also called a technical file or a device master file. A lot of authorities and notified bodies use the STED (Summary Technical Documentation) as a guide. Use of the Assessment Checklist The questions of this checklist are addressed to the auditor, who evaluates and documents the fulfillment of the requirements. The company has chosen a conformity assessment route per Annex II, excluding section 4, which pertains to design dossiers for Class III products. Whether a gap analysis between your current Medical Devices Directive (MDD) and MDR compliance is needed; Whether your current Technical Documentation can meet MDR requirements Learn how far your company has to go to reach MDR compliance for CE Mark certification with our Checklist. VOL 023 Appendix-B Requirements Specification, Fig. 5: Table comparing the documents and requirements of different legal systems. Classes. An 8-part webinar-based course reviewing the requirements of Regulation (EU) 2017/745 and comparing the requirements with the MDD (93/42/EEC as modified by 2007/47/EC). Certificates issued by Notified Bodies with reference to Council Directives 93/42/EEC, 98/79/EC, and 90/385/EEC: Mar 2010 NBOG BPG 2010-2: Guidance on Audit Report Content: Mar 2010: NBOG BPG 2010-1: Guidance for Notified Bodies auditing suppliers to medical device manufacturers: Mar 2010: NBOG BPG 2009-4 This includes for example the review of the QM documentation. Manufacturers can get an overview as quickly as possible as to what they have to document. Detailed within Annex I of the MDD and AIMDD, the ‘ Essential Requirements ’ laid out the requirements that devices must meet in order to state compliance to the directives. An SPR checklist could then be used for new projects so that new devices are compliant with the SPRs in the MDR when they come out of the new product pipeline. The MDR was published in May 2017, marking the start of a three-year period of transition from the MDD and the AIMDD. Duration Transient Normally intended for continuous use for less than 60 minutes. The MDR will replace the current EU’s Medical Device Directive (93/42/EEC) and the EU’s Directive on active implantable medical devices (90/385/EEC). @K3���7�9���^������:*��~�~���=}Z���?�ٺ�NΫ��ռ�U��L�īW����9�䘵�M59��š����t�T�?��Lںm���-�yϞ���U�h���W��ݯ���eN����:R�Vg��f͔�Ζ���d��푕�b8!0��;�=���٧�W�z�#j^��¿��,gר�������-��MZ���E[ϦWNj�Y�x5i��nC0�[M����#�lD�AaH���x~Y=_\-������tq�XO��g�պ=��Wq���8b���4DSM>�o���l�';m_���.��[�t��X��if�E�>�ڋ���>��3^����9��� Np�*�Z�}.�G?�:��>���Qci\���!�uIO~g?�_����zh��{�/ć�H0>�#=ϱT1�8'�� 8$e�P���\��M������4��A`pD2��2H8Ks��˻�8�t&˜� vT,`���L�,��m�N��B�%ɓ�=p֕c�*K���j}����VC)���M����+w�Z+x�] ^u��z�#x����y�f/�����^@�=���V��Z��B�־��5/&��֎��-�_ EU Medical Devices Directive M5 Amendment 93 42 EEC Regulatory Update - BSI British Standards presentation 1. It differentiates between several files: The Canadian authorities have published their own idea of the structure of the technical documentation based on the STED structure. mdd annex ii – ec declaration of conformity (Full Quality Assurance System) The EC declaration of conformity is the procedure whereby the manufacturer who fulfils the obligations imposed by Section 1 (of the Directive) ensures and declares that the products concerned meet the provisions of the Directive which apply to them. They are legally not binding. (MDD) 93/42/EEC as modified by 2007/47/EC. �Ϭ����KX�R�|�������sFx-g�k�$~���L( Ô�F��-DŽS If any of these approvals have been obtained on or before 31 December 2004, submission of … The structure shown in Fig. The Medical Device Regulation (MDR) does not just define requirements for the device (Annex I), it also defines the requirements for the documentation itself (Annex II). conducts an opening meeting among the auditors and audit heads to ensure the availability of the resources and facilities required to conduct the audit. After granting the EC certificate and the certificate according to ISO 13485, we conduct annual surveillance audits of individual parts of the system to check the operation of the system and a re-assessment audit every three years. 411.08 Checklist for evaluation of the essential requirements according to the medical device directive 93/42/EEC Annex II Ref: Device: Date: More Reviews ›› Visit Site Essential Requirements Checklist - Medical Device Academy . DQS: 13485 & MDD Checklist.This checklist guides organizations through compliance with ISO 13485:2016 and MDD, the European Union’s Medical Device … We are happy to help, quickly and cost-effectively. Annex I of 93/42/EEC: EU Medical Device Directive (MDD) is entitled “Essential Requirements”. The content, on the other hand, must be created by the appropriate specialist departments. with a, Description of the device, including variants, configuration and, Information on the design and manufacture of the device. N/a N/a 1/4/2019 3. This checklist has now been formalized in the standard ISO/TR 16142. requests: Person Responsible for Regulatory Compliance, Glossary for medical device manufacturers, In Vitro Diagnostic Medical Device Performance Evaluation, Association of Southeast Asian Nations (ASEAN), team of consultants helps with writing and reviewing technical documentation, A general description of the product, including any variants planned and its, The design specifications, including the standards which will be applied and the results of the risk analysis, and also a description of the solutions adopted to fulfill the essential requirements which apply to the products if the. Stage 2 Prior to the audit you will receive an audit plan. Auditing clinical processes is an integral part of our QMS audits for all medical device manufacturers. Template!Created!by!Jennifer!Cardinal!on!943042013(redlines!represent!changes!in!compromiseamendment)! h��Ymo7�+��J��� !%)i����TB|X�mr�Dw� Time flies and, before you know it, the MDD will be no more. The checklist will provide an immediate status of the compliance evidence for the MDR GSPR with utilizing the MDD ER information. In other words: Without a consistent, standard-compliant and complete technical documentation, medical device manufacturers cannot prove that their medical device meets the essential requirements or that their QM system is effective. The Practice contracts out decontamination services with an organisation that complies with (MDD) 93/42 EEC and is registered with a MHRA approved body. Use the download button below or simple online reader. The Association of Southeast Asian Nations (ASEAN) has also published a proposal for the structure of the technical documentation, the Common Submission Dossier Template (CSDT). endstream endobj startxref √ N 1/4/2019 2. … He has years of hands-on experience of industry standards and regulation such as ISO 13485, ISO 14971, ISO 10993, IEC 60601-1, IEC 62304, IEC 62366, MDD 93/42/EEC, 21CFR, CMDCAS (MDSAP) amongst others. \鈷|sX��9>�gu/ #ҜC�!� ���)z�O�J� Manufacturers are legally obliged to demonstrate compliance with these requirements. OJ L 169, 12.7.1993, p. 1–43 (ES, DA, DE, EL, EN, FR, IT, NL, PT) Special edition in Finnish: Chapter 13 Volume 024 P. 85 - 125 This file must provide similar information: The notified bodies have also published recommendations, such as NB-MED/2.5.1. The authorities and notified bodies can quickly find their way around and review the technical documentation thanks to a uniform and logical structure. From 25 May 2025, all medical devices marketed in the EU must be compliant to MDR. If necessary, additional requirements of the Member States must be complied with. The regulatory requirements do not specify how manufacturers should structure the technical documentation. Audit Checklist - IsO 13485 and MDD There is document - Audit Checklist - IsO 13485 and MDD available here for reading and downloading. We also provide an exam (i.e., 10-question quiz) to verify training effectiveness for internal auditors performing technical file auditing. Consequently, focussed clinical audits are conducted as a risk-based surveillance activity within the regular conformity assessment process under the MDR. Identification of the device (e.g. Policy Title: MDSAP AUDIT APPROACH . Council Directive 93/42/EEC of 14 June 1993 concerning medical devices Official Journal L 169 , 12/07/1993 P. 0001 - 0043 Finnish special edition: ... as specified in Section 3 and is subject to audit as laid down in Sections 3.3 and 4 and to Community surveillance as specified in Section 5. h�b```�),:����ea�؀�l�]cT��@����J�36+^ �tE�������\$?Ptv��F@M�{����C❂�'^(f`T���� To ensure that manufacturers do not lose track, we recommend using a “mapping table” containing all the documents or aspects that have to be addressed in the respective legal systems. The audit was conducted … Now www.dqs-med.de. Medical Device Directive 93/42/EEC Since the 14th June of 1998 each medical device must carry a CE mark. 3: Structure of technical documentation according to the ASEAN CSDT (click to enlarge). 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