| 新版Annex |
Regulation (EU) 2017/745 (2020/4/24)( 官方)Notified Body
(Medical Device Standards)(Hormonized Standards_All)歐盟醫療登錄系統 (EUDAMED database ) |
| content |
- Regulation (EU) 2017/746 (IVDR) is a regulation of the European Union on the placing on the market and putting into service of in vitro diagnostic medical devices (IVD), repealing Directive 98/79/EC (IVDD), which also concerned IVD. The regulation was published in April 2017 and is closely aligned to the EU regulation on medical devices.體外診療定義
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Guidance on appropriate surveillance regarding the transitional provisions under Article 120 of the MDR with regard to devices covered by certificates according to the MDD or the AIMDD |
| Article 1 |
CHAPTER I
SCOPE AND DEFINITIONS |
| Article 2 |
Definitions
For the purposes of this Regulation, the following definitions apply |
| Article 3 |
Amendment of certain definitions |
| Article 4 |
Regulatory status of products |
| Article 5 |
CHAPTER II
MAKING AVAILABLE ON THE MARKET AND PUTTING INTO SERVICE OF DEVICES, OBLIGATIONS OF ECONOMIC OPERATORS, REPROCESSING, CE MARKING, FREE MOVEMENT |
| Article 6 |
Distance sales |
| Article 7 |
Claims |
| Article 8 |
Use of harmonised standards |
| Article 9 |
Common specifications |
| Article 10 |
General obligations of manufacturers |
| Article 11 |
Authorised representative授權代表 |
| Article 12 |
Change of authorised representative 變更授權代表 |
| Article 13 |
General obligations of importers進口商的一般義務 |
| Article 14 |
General obligations of distributors |
| Article 15 |
Person responsible for regulatory compliance法規合規負責人 |
| Article 16 |
Cases in which obligations of manufacturers apply to importers, distributors or other persons |
| Article 17 |
Single-use devices and their reprocessing |
| Article 18 |
Implant card and information to be supplied to the patient with an implanted device |
| Article 19 |
EU declaration of conformity |
| Article 20 |
CE marking of conformity |
| Article 21 |
Devices for special purposes |
| Article 22 |
Systems and procedure packs |
| Article 23 |
Parts and components |
| Article 24 |
Free movement |
| Article 25 |
CHAPTER III
IDENTIFICATION AND TRACEABILITY OF DEVICES, REGISTRATION OF DEVICES AND OF ECONOMIC OPERATORS, SUMMARY OF SAFETY AND CLINICAL PERFORMANCE, EUROPEAN DATABASE ON MEDICAL DEVICES |
| Article 26 |
Medical devices nomenclature命名法 |
| Article 27 |
Unique Device Identification system |
| Article 28 |
UDI database |
| Article 29 |
Registration of devices |
| Article 30 |
Electronic system for registration of economic operators |
| Article 31 |
Registration of manufacturers, authorised representatives and importers |
| Article 32 |
Summary of safety and clinical performance |
| Article 33 |
European database on medical devices |
| Article 34 |
Functionality of Eudamed |
| Article 35 |
CHAPTER IV
NOTIFIED BODIES |
| Article 36 |
Requirements relating to notified bodies |
| Article 37 |
Subsidiaries and subcontracting |
| Article 38 |
Application by conformity assessment bodies for designation |
| Article 39 |
Assessment of the application |
| Article 40 |
Nomination of experts for joint assessment of applications for notification |
| Article 41 |
Language requirements |
| Article 42 |
Designation and notification procedure |
| Article 43 |
Identification number and list of notified bodies |
| Article 44 |
Monitoring and re-assessment of notified bodies |
| Article 45 |
Review of notified body assessment of technical documentation and clinical evaluation documentation |
| Article 46 |
Changes to designations and notifications |
| Article 47 |
Challenge to the competence of notified bodies |
| Article 48 |
Peer review and exchange of experience between authorities responsible for notified bodies |
| Article 49 |
Coordination of notified bodies |
| Article 50 |
List of standard fees |
| Article 51 |
CHAPTER V
CLASSIFICATION AND CONFORMITY ASSESSMENT
SECTION 1
Classification
Article 51 |
| Article 52 |
SECTION 2
Conformity assessment
Conformity assessment procedures |
| Article 53 |
Involvement of notified bodies in conformity assessment procedures |
| Article 54 |
Clinical evaluation consultation procedure for certain class III and class IIb devices |
| Article 55 |
Mechanism for scrutiny of conformity assessments of certain class III and class IIb devices |
| Article 56 |
Certificates of conformity |
| Article 57 |
Electronic system on notified bodies and on certificates of conformity |
| Article 58 |
Voluntary change of notified body |
| Article 59 |
Derogation from the conformity assessment procedures |
| Article 60 |
Certificate of free sale |
| Article 61 |
CHAPTER VI
CLINICAL EVALUATION AND CLINICAL INVESTIGATIONS
Article 61 |
| Article 62 |
General requirements regarding clinical investigations conducted to demonstrate conformity of devices |
| Article 63 |
Informed consent |
| Article 64 |
Clinical investigations on incapacitated subjects |
| Article 65 |
Clinical investigations on minors |
| Article 66 |
Clinical investigations on pregnant or breastfeeding women |
| Article67_69 |
Additional national measures |
| Article 68 |
Clinical investigations in emergency situations |
| Article 69 |
Damage compensation |
| Article 70 |
Application for clinical investigations |
| Article 71 |
Assessment by Member States |
| Article 72 |
Conduct of a clinical investigation |
| Article 73 |
Electronic system on clinical investigations |
| Article 74 |
Clinical investigations regarding devices bearing the CE marking |
| Article75 |
Substantial modifications to clinical investigations |
| Article 76 |
Corrective measures to be taken by Member States and information exchange between Member States |
| Article 77 |
Information from the sponsor at the end of a clinical investigation or in the event of a temporary halt or early termination |
| Article 78 |
Coordinated assessment procedure for clinical investigations |
| Article 79_80 |
Review of coordinated assessment procedure |
| Article 80 |
Recording and reporting of adverse events that occur during clinical investigations |
| Article 81_82 |
Implementing acts |
| Article 82 |
Requirements regarding other clinical investigations |
| Article 83_85 |
CHAPTER VII
POST-MARKET SURVEILLANCE, VIGILANCE AND MARKET SURVEILLANCE
SECTION 1
Post-market surveillance
Post-market surveillance system of the manufacturer |
| Article 84 |
Post-market surveillance plan |
| Article 85 |
Post-market surveillance report |
| Article 86 |
Periodic safety update report |
| Article 87 |
SECTION 2
Vigilance
Reporting of serious incidents and field safety corrective actions |
| Article 88 |
Trend reporting |
| Article 89 |
Analysis of serious incidents and field safety corrective actions |
| Article 90_91 |
Analysis of vigilance data |
| Article 91 |
Implementing acts |
| Article 92 |
Electronic system on vigilance and on post-market surveillance |
| Article 93-100 |
SECTION 3
Market surveillance
Article 93(UDI)
Market surveillance activities |
| Article 101-108 |
CHAPTER VIII
COOPERATION BETWEEN MEMBER STATES, MEDICAL DEVICE COORDINATION GROUP, EXPERT LABORATORIES, EXPERT PANELS AND DEVICE REGISTERS
Article 101
Competent authorities |
| Article 109-113 |
CHAPTER IX
CONFIDENTIALITY, DATA PROTECTION, FUNDING AND PENALTIES
Article 109
Confidentiality |
| Article 114-123 |
CHAPTER X
FINAL PROVISIONS
Article 114
Committee procedure |