248:, that are similar in principle to medical devices but without a specific medical intended purpose. Annex XVI of the MDR lists the six categories of products that are covered by this scope. The groups includes devices such as cosmetic contact lenses, tattoo removal lasers, equipment for liposuction, and others. Instead of showing a clinical benefit, manufacturers of such products are required to demonstrate their performance and safety in the clinical evaluation.
47:
371:. The so-called "Summary of Safety and Clinical Performance" (SSCP), required for some high-risk medical devices, will also be accessible to the public through the database. More details on the operation of EUDAMED are given in Commission Implementing Regulation (EU) 2021/2078. A similar database is the
403:
In accordance with §103 of the MDR, the
Medical Device Coordination Group (MDCG) has been established. The MDCG and its sub-groups publish guidances that provide clarification and support to national competent authorities, notified bodies and economic operators on the details of the implementation of
289:
The MDR in § 15 introduces the role of the "person responsible for regulatory compliance" (PRRC), that manufacturers and authorized representatives will have to have available within their organisation. The PRRC is assigned several duties and responsibilities, including making sure postmarketing
382:
As a key to
Eudamed, the MDR introduces the Basic UDI-DI as unique device identifier. A medical device (including system- and procedure packs and IVD) needs to have an assigned Basic UDI-DI and needs to be registered in the UDI/Device part of EUDAMED. Devices with their own UDI-DI from the same
423:
Additional provisions for the transition from MDD to MDR are found in
Article 120 of the regulation. Due to certain issues, some additional transition timelines were implemented in 2023, amending Article 120 and allowing for some delays in re-certification up until 2028 for class III and IIB
312:
Compared to the MDD ER, the MDR GSPR have been expanded, e.g. with regards to devices for lay use, IT security, and devices without a medical purpose. Manufacturers are expected to utilize harmonized standards and common requirements to demonstrate conformance to the GSPR.
220:
are now included in their own category, often called "I R". As per § 120(3) of the regulation, aspects relating to their re-usability, are under the scope of
Notified Body review starting 26 May 2024. This includes aspects relating to reprocessing and (re-)sterilization.
57:
Regulation (EU) 2017/745 of the
European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC (Text with EEA
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surveillance obligations are fulfilled. Persons taking on the role and responsibilities of a PRRC have to meet certain qualitifcations with regard to education and experience. Further details on the PRRC are given in the EU guidance MDCG 2019-7.
717:
Regulation (EU) 2023/607 of the
European Parliament and of the Council of 15 March 2023 amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards the transitional provisions for certain medical devices and in vitro diagnostic medical
205:
Compared to the MDD, the scope of the MDR has been expanded to cover not only the active implantable medical devices previously covered by the Active
Implantable Medical Device Directive 90/385/EWG (AIMDD) but also a range of
554:
280:
Manufacturers, authorised representatives and importers have to register in the EUDAMED database to receive a Single
Registration Number (SRN); only distributors of medical devices do not have to register.
168:
The regulation was published on 5 April 2017 and came into force on 25 May 2017. Originally approved medical devices will have a transition time of three years (until 26 May 2021) to meet new requirements.
298:
The "General Safety and
Performance Requirements" (GSPR) of the MDR replace the "Essential Requirements" (ER) of the MDD. Annex I of the MDR lists 23 requirements, divided in three chapters:
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416:
The date by which the
Regulation was to be fully implemented by replacing the previous directives was originally defined as 26 May 2020. Following the international health emergency
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implantable devices, and for 2027 for some others, under certain circumstances; the "sell-off" provision of MDD-licensed devices, previously May 2025, was also removed.
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Data on economic operators, devices registration and certificates are available to the public. The database will allow to link manufacturer's certification and
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Changes compared to the Medical Device Directive include changes in device classification and device scope, stricter oversight of manufacturers by
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manufacturer with same intended purpose, risk class and essential design and manufacturing characteristics can be grouped under one Basic UDI.
17:
584:
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181:, introduction of the "person responsible for regulatory compliance" (PRRC) and of the economic operator concept, the requirement of
165:(MDD), which concerns medical devices, and Directive 90/385/EEC, which concerns active implantable medical devices, on 26 May 2021.
420:, the European Commission and the European Parliament decided in April 2020 to postpone the deadline by one year to 26 May 2021.
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Additionally, the classification rules of Annex VIII of the MDR have been expanded compared to the MDD to now 22 rules.
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in relation to medical devices. The obligations of economic operators are detailed in the following sections:
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325:) is a database to collect and publish information on medical devices and in-vitro-diagnostica.
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210:. This category includes devices similar to medical devices, as listed in Annex XVI.
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Directive 2001/83/EC, Regulation (EC) No 178/2002, and Regulation (EC) No 1223/2009
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577:"New Medical Devices Regulation and IVD Regulation text published – BSI Group"
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that do not have a previously assigned Basic UDI-DI, they are assigned an
408:. The members of the MDCG are experts appointed by the EU member states.
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for the purpose of registration in EUDAMED. Instead of the UDI-DI, an
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Requirements regarding the information supplied with the device (23)
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of the European Union on the clinical investigation and sale of
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693:"Texts adopted - Medical devices ***I - Friday, 17 April 2020"
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The MDR in §2 (35) now defines several different roles for
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521:"Regulatory Affairs Professionals Society | RAPS"
460:"Regulatory framework – Growth – European Commission"
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Requirements regarding design and manufacture (10-22)
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185:marking for devices, EUDAMED registration (see
436:on in vitro diagnostic medical devices (IVDR)
373:Global Unique Device Identification Database
285:Person responsible for regulatory compliance
246:products without an intended medical purpose
240:Products without an intended medical purpose
208:products without an intended medical purpose
294:General safety and performance requirements
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321:The European database on medical devices (
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131:Directive 90/385/EEC, Directive 93/42/EEC
224:Other classification changes relate to
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739:
411:
491:"A new landscape for medical devices"
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317:European database on medical devices
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699:from the original on 21 April 2020
673:from the original on 31 March 2023
395:can be assigned for registration.
25:
768:
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619:from the original on 12 July 2024
587:from the original on 12 July 2024
501:from the original on 12 July 2024
399:Medical Device Coordination Group
757:Regulation in the European Union
557:from the original on 24 May 2018
527:from the original on 24 May 2018
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470:from the original on 3 May 2018
234:substance-based medical devices
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653:
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547:"EU Medical Device Regulation"
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489:Duhs, Gustaf (27 March 2018).
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244:The scope of the MDR includes
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1:
752:Regulation of medical devices
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218:reusable surgical instruments
639:"What about Legacy devices?"
193:requirements, and increased
183:Unique Device Identification
18:EU medical device regulation
7:
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10:
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747:European Union regulations
365:Single Registration Number
302:General requirements (1-9)
195:postmarketing surveillance
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161:for human use. It repeals
88:L117, 5 May 2017 pp. 1–175
328:EUDAMED has six modules:
269:Authorised Representative
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39:European Union regulation
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434:Regulation (EU) 2017/746
355:post-market surveillance
201:Scope and classification
151:Regulation (EU) 2017/745
350:and performance studies
348:Clinical Investigations
252:Economic operator roles
732:Text of the regulation
118:(new date) 26 May 2021
440:Medical device design
367:(SRN) as well as the
338:/Devices registration
27:Political regulation
412:Implementation date
359:Market Surveillance
332:Actors registration
163:Directive 93/42/EEC
144:Current legislation
115:Implementation date
34:
264:§10 - Manufacturer
258:economic operators
76:TFEU/art 294 par 6
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649:on 3 August 2021.
276:§14 - Distributor
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123:Other legislation
16:(Redirected from
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375:(GUDID) of the
342:Notified Bodies
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232:(rule 19), and
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179:notified bodies
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159:medical devices
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647:the original
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581:bsigroup.com
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404:the MDR and
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197:activities.
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102:5 April 2017
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551:tuv-sud.com
236:(rule 21).
228:(rule 11),
110:25 May 2017
741:Categories
446:References
393:EUDAMED ID
389:EUDAMED-DI
155:regulation
73:Made under
58:relevance)
33:Regulation
661:"EUDAMED"
607:"EUDAMED"
369:Basic UDI
99:Date made
84:reference
703:21 April
697:Archived
668:Archived
614:Archived
591:12 April
585:Archived
561:12 April
555:Archived
531:12 April
525:Archived
505:12 April
499:Archived
474:12 April
468:Archived
428:See also
418:COVID-19
226:software
128:Replaces
718:devices
677:12 July
623:12 July
323:EUDAMED
173:Changes
94:History
82:Journal
67:Council
63:Made by
464:Growth
267:§11 -
216:Also,
136:Amends
671:(PDF)
664:(PDF)
617:(PDF)
610:(PDF)
187:below
153:is a
54:Title
705:2020
679:2024
625:2024
593:2018
563:2018
533:2018
507:2018
476:2018
406:IVDR
377:FDA
336:UDI
191:UDI
189:),
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