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The European Authorized Representative activities in view of newly published MDR
Free Sales Certifcates 4
Post-Market Surveillance 3
Incident Reporting 2
Registration Issues in Europe 1
Agenda
20. November 2017
20. November 2017
… means any natural or legal person established
within the Union who has received and accepted
a written mandate from a manufacturer, located
outside the Union, to act on the manufacturer's
behalf in relation to specified tasks with regard to
the latter's obligations under this Regulation
… means any natural or legal person established
in the Community who, explicitly designated by
the manufacturer, acts and may be addressed by
authorities and bodies in the Community instead
of the manufacturer with regard to the latter's
obligations under this Directive
MDR 2017/745 MDD 93/42/EEC
Free Sales Certifcates 4
Post-Market Surveillance 3
Incident Reporting 2
Registration Issues in Europe 1
Agenda
20. November 2017
This allows market surveillance by the competent authority
20. November 2017
Authorized Representative shall inform the
competent authority of the member state in which
he has his registered place of business about
• his place of business
• the devices for that he is responsible
Why do you need to register your product in Europe ?
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Before placing a device on the market, authorised
representatives shall submit information about
himself, the person responsible for regulatory
compliance and the devices for that he is responsible
to a central electronic system (EUDAMED). The
information must be confirmed regularly.
MDR 2017/745, Art. 29 MDD 93/42/EEC Art. :
Information needed by your EC-Representative for registration
• Basic UDI-DI* • Member state where the products shall be marketed * • Summary of safety and clinical performance* • CE-Certificate (if applicable)* • Declaration of conformity* • Product description* • Label • Instruction for use • List of applied standards • Summary of preclinical evaluation (e.g. Biocompatibility testing) • If applicable, information on the OEM manufacturer • ….
• CE-Certificate (if applicable)* • Declaration of conformity* • Product description / brochure • Label • Instruction for use • List of applied standards • Summary of preclinical
evaluation (e.g. Biocompatibility testing)
* must be provided to the competent authority
MDR 2017/745 (detailed requirements in Annex VI) MDD 93/42/EEC:
* must be uploaded into EUDAMED
• Notified Body involved
• Certifcation by Notified Body
• Less strict surveillance
• No notified body involved
• Self-certification by manufacturer
• much more critical surveillance by
competent authority
Class IIa, IIb, III devices Class I devices
20. November 2017
Competent authorities role
7
Free Sales Certifcates 4
Post-Market Surveillance 3
Incident Reporting 2
Registration Issues in Europe 1
Agenda
20. November 2017
20. November 2017
European Vigilance System, Incident definition
Any malfunction or deterioration in the characteristics and/or performance of a device, as well as any inadequacy in the labeling or the instructions for use which, directly or indirectly, might lead to or might have led to the death of a patient, or user or of other persons or to a serious deterioration in their state of health.
MDD 93/42/EEC
9
incident: Any malfunction or deterioration in the characteristics or performance of a device made available on the market, including use-error due to ergonomic features, as well as any inadequacy in the information supplied by the manufacturer and any undesirable side-effect serious incident: Any incident that directly or indirectly led, might have led or might lead to any of the following: (a) the death of a patient, user or other person, (b) the temporary or permanent serious deterioration of a patient's, user's or other person's state of health, (c) a serious public health threat
MDR 2017/745
Reporting timelines are no longer a Guideline but Legislation
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Serious public health threat: IMMEDIATELY (without any delay that could not be justified) but not later than 2 calendar days after awareness by the manufacturer of this threat.
Death or unanticipated serious deterioraton in state of health: IMMEDIATELY (without any delay that could not be justified) after the manufacturer established a link between the device and the event but not later than 10 calendar days following the date of awareness of the event.
Others: IMMEDIATELY (without any delay that could not be justified) after the manufacturer established a link between the device and the event but not later than 30 calendar days following the date of awareness of the event.
MEDDEV 2.12-1
Serious public health threat: IMMEDIATELY but not later than 2 calendar days after awareness by the manufacturer of this threat. Death or unanticipated serious deterioraton in state of health: IMMEDIATELY after the manufacturer established a link between the device and the event but not later than 10 calendar days following the date of awareness of the event. Others: IMMEDIATELY after the manufacturer established a link between the device and the event but not later than 15 calendar days following the date of awareness of the event.
MDR 2017/745
Free Sales Certifcates 4
Post-Market Surveillance 3
Incident Reporting 2
Registration Issues in Europe 1
Agenda
20. November 2017
Post Marketing Surveillance - no longer a Guideline but Legislation
MDD, various Annexes mention: „systematic procedures“ to review experience gained from devices in the post-production phase
⇒ Quality Management System
MEDDEV-Guidelines on Market Surveillance:
MEDDEV 2.12/1 rev.8 Guidelines on a Medical Devices Vigilance System
MEDDEV 2.12/2 rev.2
Post Market Clinical Follow-up studies
MDD 93/42/EEC: Chapter VIII: Post-market surveillance, vigilance and market surveillance:
For each device, manufacturers shall plan, establish, document, implement, maintain and update a post-market surveillance system proportional to the risk class…
The post-market surveillance system shall be based on a post-market surveillance plan as described in Annex III
Post-market surveillance reports for class I devices, updates when necessary and to be provided to authorities upon request.
Periodic safety update report for class IIa, IIb and III as follows
MDR 2017/745
20. November 2017
Post Marketing Surveillance – for high(er) risk class devices
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• Manufacturers of class IIa, class IIb and class III devices shall prepare a periodic safety
update report (‘PSUR’) for each device and where relevant for each category or group of devices…
PSUR is part of the technical file PSUR shall set out: a) the conclusions of the benefit-risk determination; b) the main findings of the Post Marketing Clinical Follow-up; c) the volume of sales of the device and an estimate evaluation of the size and other
characteristics of the population using the device and, where practicable, the usage frequency of the device.
MDR 2017/745 ̶ Chapter VIII, Article 86:
20. November 2017
Post Marketing Surveillance – for high(er) risk class devices
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• class IIb and class III devices: update of the PSUR at least annually • class IIa devices: update the PSUR when necessary and at least every two years Make available the PSUR to the notified body and upon request to the competent authorities. • class III devices or implantable devices: submit PSURs to the notified body involved via
EUDAMED. The notified body shall review the report and add its evaluation to EUDAMED.
• PSURs and the evaluation by the notified body shall be made available to competent authorities via EUDAMED
MDR 2017/745 ̶ Chapter VIII, Article 86:
Free Sales Certifcates 4
Post-Market Surveillance 3
Incident Reporting 2
Registration Issues in Europe 1
Agenda
20. November 2017
20. November 2017
Free Sales Certificates are needed to enable sales in certain countries e.g.:
• Egypt • Argentina • India • Brasil • Iran • Etc.
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• FSC are also called Certificates of Marketability
• The authority certifies the compliance with the relevant legislation
• The authority certifies the marketability of the devices in the European Community
• Only available for registered devices
What are FSCs ?
Free Sales Certificates – how they look like
Free Sales Certificates in view of the new MDR
• Today FSC issued by competent authority
(that register the product)
• With EUDAMED and MDR not clear
whether any changes in issuing of FSC
MedNet GmbH, Borkstraße 10, 48163 Münster, Germany www.mednet-eurep.com / [email protected]
Tel +49 251 32266 0 / MP +86 132 1016 7238
