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1、RECOMMENDATIONS COMMISSION RECOMMENDATION of 24 September 2013 on the audits and assessments performed by notified bodies in the field of medical devices(Text with EEA relevance)(2013/473/EU)THE EUROPEAN COMMISSION,Having regard to the Treaty on the Functioning of the European Union,and in particula
2、r Article 292 thereof,Whereas:(1)The proper functioning of notified bodies is crucial for ensuring a high level of health and safety protection,the free movement of medical devices in the internal market,and citizens confidence in the regulatory system.(2)Council Directive 90/385/EEC of 20 June 1990
3、 on the approximation of the laws of the Member States relating to active implantable medical devices(1),Council Directive 93/42/EEC of 14 June 1993 concerning medical devices(2),and Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical de
4、vices(3),contain certain provisions with regard to the audits,assessments and unannounced audits performed by notified bodies in the field of medical devices.(3)The interpretation of those provisions and the behaviour of notified bodies designated in the field of medical devices differ.Therefore thi
5、s Recommendation should set benchmarks for assessments and unannounced audits by notified bodies and respond to the most frequent shortcomings of the current practices.(4)The Recommendation aims at ensuring that the notified body carries out a proper verification of the fulfilment of the legal requi
6、rements by the manufacturer.(5)Subject to the respective conformity assessment procedure,notified bodies perform product assessments or quality system assessments.Accordingly,it is important to differentiate between these two types of assessments.To verify the continuous compliance with legal obliga
7、tions,notified bodies should perform unannounced audits in addition to product assessments and quality system assessments.(6)In order to satisfy the legal requirements laid down in Directive 90/385/EEC,in Directive 93/42/EEC and in Directive 98/79/EC,notified bodies should verify,where relevant,the
8、fulfilment of the essential safety and health requirements contained in Directive 2006/42/EC of the European Parliament and of the Council of 17 May 2006 on machinery,and amending Directive 95/16/EC(4),of the requirements contained in Commission Regulation(EU)No 722/2012 of 8 August 2012 concerning
9、particular requirements as regards the requirements laid down in Council Directives 90/385/EEC and 93/42/EEC with respect to active implantable medical devices and medical devices manufactured utilising tissues of animal origin(5)and of the common technical specifications for in vitro diagnostic med
10、ical devices laid down in Commission Decision 2002/364/EC of 7 May 2002 on common technical specifications for in vitro diagnostic medical devices(6).(7)In order to avoid omissions and mistakes in the verification by the notified bodies of the important aspects of clinical evaluation or,in the case
11、of in vitro diagnostic medical devices,of performance evaluation,and with regard to the post-market clinical follow-up,or,in the case of in vitro diagnostic medical devices,to post-market follow up,it is important to provide specific advice with regard to the control of those requirements.(8)To faci
12、litate the verification by the notified bodies of the technical documentation,the manufacturers device identification system and the declaration of conformity,it is important to provide specific advice with regard to the control of those requirements.Directive 90/385/EEC,Directive 93/42/EEC and Dire
13、ctive 98/79/EC do not provide any exceptions for outsourced production compared to in-house production.Accordingly,it is necessary to include in duly substantiated cases the most important subcontractors and suppliers in the conformity assessment procedures.EN 25.9.2013 Official Journal of the Europ
14、ean Union L 253/27(1)OJ L 189,20.7.1990,p.17.(2)OJ L 169,12.7.1993,p.1.(3)OJ L 331,7.12.1998,p.1.(4)OJ L 157,9.6.2006,p.24.(5)OJ L 212,9.8.2012,p.3.(6)OJ L 131,16.5.2002,p.17.(9)Subcontractors or suppliers cannot fulfil in the manufacturers place crucial obligations of manufacturers,such as keeping
15、available the full technical documentation,as this would void the concept of the manufacturer as responsible in accordance with Directive 90/385/EEC,Directive 93/42/EEC and Directive 98/79/EC.Therefore,the notified bodies should be advised on what they need to verify in case of outsourcing.(10)Thoug
16、h regarded as two independent exercises,it is necessary to strengthen the link between the quality system review and the review of the technical documentation on a sampling basis.(11)In the absence of established practice for unannounced audits it is important to determine the practicalities for suc
17、h audits,as well as to provide advice on the arrangements needed for facilitating these audits,HAS ADOPTED THIS RECOMMENDATION:1.PURPOSE To facilitate the consistent application of the conformity assessment provisions contained in Directive 90/385/EEC,Directive 93/42/EEC and Directive 98/79/EC,the n
18、otified bodies should apply the provisions of this Recommendation when they perform product assessments,quality system assessments and unannounced audits.By providing general guidelines for such assessments and unannounced audits,this Recommendation should facilitate the work of the notified bodies
19、as well as the Member States evaluation thereof.This Recommendation does not create any new rights and obligations.The legal requirements applicable to all types of devices and conformity assessments are set out in the Union legislation on medical devices.2.GENERAL GUIDELINES FOR AUDITS AND ASSESSME
20、NTS The notified bodies should apply the following:(a)Where the manufacturer has applied for a design dossier examination or for a type examination(hereinafter jointly referred to as product assessment),notified bodies should verify the conformity of the device under all product related aspects refe
21、rred to in Directive 90/385/EEC,Directive 93/42/EEC and Directive 98/79/EC for detecting any non-compliance of the device and should apply Annex I.(b)Where the manufacturer has applied for an assessment of its quality system,notified bodies should verify the conformity of the quality system with the
22、 quality-system related requirements contained in Directive 90/385/EEC,Directive 93/42/EEC and Directive 98/79/EC for detecting non-compliances of the quality system and should apply Annex II.(c)To verify the day-to-day compliance with legal obligations,notified bodies should,in addition to the init
23、ial,surveillance or renewal audits,visit the manufacturer or,if this is likely to ensure more efficient control,one of its subcontractors in charge of processes which are essential for ensuring compliance with legal requirements(critical subcontractor)or a supplier of crucial components or of the en
24、tire devices(both:crucial supplier)without prior notice(unannounced audits)in accordance with Annex III.3.FOLLOW-UP Member States should draw this Recommendation to the attention of the notified bodies in the field of medical devices and should supervise the practice of notified bodies with respect
25、to this Recommendation.They should evaluate the notified bodies readiness to apply this Recommendation and in particular to perform unannounced audits when deciding on designations of bodies and on renewal or withdrawal of designations.4.ADDRESSEES This Recommendation is addressed to the Member Stat
26、es.Done at Brussels,24 September 2013.For the Commission Neven MIMICA Member of the CommissionEN L 253/28 Official Journal of the European Union 25.9.2013ANNEX I Product assessment 1.Notified bodies should verify if the device is correctly qualified as a medical device and,in particular,whether the
27、manufacturer has assigned a medical purpose to the device.They should furthermore verify the classification of the device and whether the manufacturer has fulfilled the applicable conformity assessment obligations.They should satisfy the obligations of consultation for certain devices that incorpora
28、te a substance which,in case used separately,may be considered to be a medicinal product,a human blood derivative or an animal tissue(1).2.Notified bodies should verify the compliance of the device with the relevant Essential Requirements set out in Annex 1 to Directive 90/385/EEC,Annex I to Directi
29、ve 93/42/EEC and Annex I to Directive 98/79/EC and,if applicable,with the essential safety and health requirements(ESHR)set out in Directive 2006/42/EC.In the case of in vitro diagnostic medical devices,where applicable,they should also verify the compliance of the device with the common technical s
30、pecifications laid down in Decision 2002/364/EC or,when duly justified,with other technical solutions of a level at least equivalent.Where doubts arise,in the framework of a design dossier examination,as to the conformity of a device,notified bodies should carry out or ask for relevant tests of the
31、device.3.Notified bodies should examine the requirements regarding design and construction and the ESHR prior to examining the general requirements set out in Part I of Annex 1 to Directive 90/385/EEC,in Part A of Annex I to Directive 93/42/EEC and in Part A of Annex I to Directive 98/79/EC.They sho
32、uld apply special care to examine all the following aspects of the essential requirements:(a)design,manufacture and packaging;(b)labelling on the device,on the packaging for each unit or on the sales packaging and instructions for use.4.The examination of the general requirements should ascertain th
33、at among others the following requirements have been met:(a)all hazards have been identified;(b)all risks associated with these hazards have been evaluated and have become part of the overall risk-benefit evaluation;(c)all these risks have been reduced as far as possible;(d)all remaining risks have
34、been subject to protection measures;(e)safety principles have been applied in a way that is compatible with the state-of-the art.5.For medical devices other than in vitro diagnostic devices,notified bodies should review all relevant preclinical data,the clinical evaluation and the post-market clinic
35、al follow-up undertaken or planned by the manufacturer.They should verify that the clinical evaluation is up-to-date.They should assess the need for and the appropriateness of a post-market clinical follow-up plan(2).If no clinical investigation has been undertaken,they should verify that the device
36、 type in question and all the different types of risks linked to the device design,its materials,and its use are appropriately assessed by means of scientific literature or other existing clinical data so that no clinical investigation is needed;they should furthermore examine the special justificat
37、ion(3)needed for implantable devices and devices classified within class III according to Annex IX to Directive 93/42/EEC.6.In the case of in vitro diagnostic medical devices,notified bodies should review the performance evaluation undertaken by the manufacturer and post-market follow up undertaken
38、or planned by the manufacturer.7.Notified bodies should verify all documentation related to the devices conformity assessment.To that end,they should verify that the technical documentation is correct,consistent,relevant,up-to-date and complete(4)and that it covers all variants and trade names of th
39、e device.They should furthermore verify that the manufacturers device identificationEN 25.9.2013 Official Journal of the European Union L 253/29(1)See Section 10 of Annex 1,Section 4.3 of Annex 2 and Section 5 of Annex 3 to Directive 90/385/EEC,Section 7.4 of Annex I,Section 4.3 of Annex II and Sect
40、ion 5 of Annex III to Directive 93/42/EEC and Regulation(EU)No 722/2012.(2)See Section 1.4 of Annex 7 to Directive 90/385/EEC and Section 1.1c of Annex X to Directive 93/42/EEC.(3)See Annex 7 to Directive 90/385/EEC and Annex X to Directive 93/42/EEC.(4)To be regarded as complete,a technical documen
41、tation should cover with appropriate depth the items listed in the document of the Global Harmonization Task Force Summary Technical Documentation for Demonstrating Conformity to the Essential Principles of Safety and Performance of Medical Devices(STED)as well as additional items required by the Eu
42、ropean legislation or,for in vitro diagnostic medical devices,Summary Technical Documentation(STED)for Demonstrating Conformity to the Essential Principles of Safety and Performance of In Vitro Diagnostic Medical Devices as well as additional items required by the European legislation,see for these
43、documents http:/www.imdrf.org/ghtf/ghtf-archives-sg1.aspsystem and its practice of defining which devices belong to the same type ensure that the notified bodys certificates,the manufacturers declarations of conformity and the manufacturers technical documentations can unequivocally be attributed to
44、 the device examined.They should finally verify that the draft declaration of conformity contains all the necessary items.8.The notified body should clearly document the conclusions of its assessment and it should be clearly evidenced how the conclusions are taken into account as part of the notifie
45、d bodys decision making process.EN L 253/30 Official Journal of the European Union 25.9.2013ANNEX II Quality system assessment 1.In the case of full quality assurance system,the verification should ascertain that the application of the quality system assures the conformity of the devices(1)with the
46、legal requirements set out in Directive 90/385/EEC,Directive 93/42/EEC and Directive 98/79/EC.In the case of production or product quality assurance,the verification should ascertain that the application of the quality system ensures the conformity of the devices with the device type(2).2.The qualit
47、y system assessment should include audits on the premises of the manufacturer and,if this is also necessary to ensure efficient control,on those of its critical subcontractors or of its crucial suppliers.Notified bodies should establish a risk-based approach to identify such subcontractors and suppl
48、iers and should clearly document this decision process.3.Notified bodies should identify which products the manufacturer regards as covered by its application,whether these products fall under Directive 90/385/EEC,Directive 93/42/EEC and Directive 98/79/EC and whether there have been changes to thes
49、e products or to the quality system since the last audit or since the application.Furthermore,notified bodies should identify the post-market information available to them or to the manufacturer,which might need to be taken into account when planning and executing the audit.4.For medical devices of
50、Class IIa or IIb,the notified bodies should review the technical documentation on the basis of representative samples with a frequency and depth following established best practices,taking account of the devices class,risk and novelty.Samples chosen and reviews conducted should be clearly documented