Responsible for regulatory compliance (Article 15 of MDR 2017/745)

#1
Hi everyone,

the new MDR had defined new responsibilities in Articel 15 of MDR 2017/745, "responsible person for regulatory compliance".
Is this a different person than required in ISO 13485 (Management Representative)?

From my understanding the MDR requires someone who makes sure the product is compliant and approves the certification procedures, whereas the person required in ISO 13485 is someone who takes the whole responsibility of the QMS and reports to the top management.

Thank you :bigwave:

Best,
Daliane
 
#2
Hi
Your summary is essentially correct. These are different tasks;

-the Responsible Person (or persons) under the MDR certify that the product meets the requirements of the MDR and that it is suitable to be released.

-the Management Representative (usually one person) ensures the processes needed for the QMS are documented, reports the effectiveness of the QMS to top management and promotes the QMS throughout the organisation.

While they can be the same person, the responsibilities are different and they can be different people.

Chris
 
#3
Great distinction thank you. Smaller companies most likely have the same person wearing "two hats" while larger organizations need to think about how this fits into their organization. I am consulting for the latter at the moment.
 

Ronen E

Problem Solver
Staff member
Super Moderator
#4
-the Responsible Person (or persons) under the MDR certify that the product meets the requirements of the MDR and that it is suitable to be released.
No offence, but this is inaccurate.
3. The person responsible for regulatory compliance shall at least be responsible for ensuring that:
(a) the conformity of the devices is appropriately checked, in accordance with the quality management system under which the devices are manufactured, before a device is released;
(b) the technical documentation and the EU declaration of conformity are drawn up and kept up-to-date;
(c) the post-market surveillance obligations are complied with in accordance with Article 10(10);
(d) the reporting obligations referred to in Articles 87 to 91 are fulfilled; (e) in the case of investigational devices, the statement referred to in Section 4.1 of Chapter II of Annex XV is issued.
 
#5
It's worth noting that the RP and QMR have different levels of authority and responsibility

The QMR is a representative of top management, top management can change the QMR and set the direction of the QMS to what they desire

The RP is responsible for ensuring compliance (broadly - see RonenE post) - the regulation requires their word to be final on the areas of their responsibility, top management should not override the RP and will likely face serious consequences if they do to the detriment of patient safety/efficacy. Similarly there will be consequences on the RP failing to perform - An RP role is not one to take on lightly in my opinion
 


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