MDR/IVDR General Obligations of Manufacturer / AR /Importer / Distributor

Obligations

Article 10 Manufacturer Obligations

Risk management system (Section 3 of Annex I)

MDR: Clinical evaluation including PMCF(Article 61 and Annex XIV) IVDR: Performance evaluation including PMPF (Article 56 and Annex XIII)

Manufacturers of devices other than custom-made devices: Technical documentation(Annex II & III)

MDR ONLY:Manufacturers of custom-made device: Documentation in accordance with Section 2 of Annex XIII.

Conformity assessment, Declaration of conformity (DoC) and CE marking (MDR Article 19 & 20/IVDR Article 17 & 18)

UDI system and registration obligations (MDR Article 27 ,Articles 29 and 31/ IVDR Article 24 ,Articles 26 and 28)

Retention period: Availability of Technical Documentation, Certificates and DoC

Quality management system

Post-market surveillance system (MDR Article 83/ IVDR Article 78)

Availability of information supplied by manufacturer

Vigilance system

Ensure implementation of corrective actions

Cooperate and coordinate with Competent authority

Registration of original equipment manufacturer in EUDAMED

Coverage of potential liability

 

 

Article 11 Authorised representative

Perform the tasks specified in the mandate agreed between Authorised representative and the manufacturer.

Verify the  EU declaration of conformity, technical documentation and Conformity assessment

Retention period: Availability of Technical Documentation, Certificates and DoC

Registration obligations and verify manufacturer registration obligations

Provide information / documentation to Competent Authority on request to demonstrate conformity in requested language

Forward to Manufacturer Competent Authority’s request for samples / access to a device and verify samples / access given

Cooperate with Competent Authorities in any preventive / corrective action to eliminate / mitigate risk

Immediately Inform Manufacturer about complaints and reports from healthcare professionals, patients and users about suspected incidents

Terminate the mandate if the manufacturer acts contrary to its obligations

 

Article 13 General obligations of importers	Article 14 General obligations of distributors
Importers shall verify: a) Device CE marked and DoC b) Manufacturer identified & that an EU AR has been designated c) Device labelling d) UDI	Distributor shall verify: a) Device CE marked, DoC b) Device labelling c) For imported devices, the Importer name and address is on the label d) UDI Distributor may apply a sampling method to perform verification (except for b) Importer labelling)
If the device not in compliance with MDR then importer shall not place the device on the market + inform Manufacturer and EU AR	If the device not in compliance with MDR then importer shall not place the device on the market + inform Manufacturer, EU AR and Importer
Where the Importer considers the device presents a serious risk or is a falsified device, it shall inform Manufacturer, EU AR and Competent Authority	Where the Distributor considers the device presents a serious risk or is a falsified device, it shall inform Manufacturer, EU AR, Importer and Competent Authority
Add contact details to device or packaging or accompanying document
Registration obligations and verify manufacturer and device registration obligations
Safeguard storage and transport conditions	Safeguard storage and transport conditions
Keep register of complaints,non-conforming devices, etc. Provide Manufacturer, EU AR and Distributors with any information requested in order to allow investigation of complaints	Keep register of complaints, non-conforming devices, recalls and withdrawals • Keep Manufacturer, EU AR and Importers informed of monitoring and provide any information upon request
If the device presents a serious risk then they shall immediately inform the Competent Authorities and the Notified Body. Co-operate with the Manufacturer, the manufacturer’s EU AR and the Competent Authorities to ensure that the necessary corrective action, withdrawal or recall is taken	If the device presents a serious risk then they shall immediately inform the Competent Authorities and the Notified Body. Co-operate with the Manufacturer, the manufacturer’s EU AR, Importer and the Competent Authorities to ensure that the necessary corrective action, withdrawal or recall is taken
Immediately Inform Manufacturer and EU AR about complaints and reports from healthcare professionals, patients and users about suspected incidents	Immediately Inform Manufacturer ,EU AR and Importer about complaints and reports from healthcare professionals, patients and users about suspected incidents
Retention period: Availability of Technical Documentation, Certificates and DoC
Cooperate with Competent Authorities, on any action taken to eliminate / mitigate the risks	Distributors shall, upon request from a Competent Authority, provide information and documentation necessary to demonstrate the conformity of a device (unless the Manufacturer or EU AR has done so) Distributors shall cooperate with Competent Authorities, on any action taken to eliminate / mitigate the risks posed by devices which they have placed on the market
Importer shall provide samples of the device free of charge to the competent authority	Distributors, upon request of a Competent Authority, shall provide samples of the device free of charge / grant access to the device

 

Source:

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

REGULATION (EU) 2017/746 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU