Personally I have some fundamentals problems with EU MDR Annex I 23.4(z) as another poorly worded requirement in the regulation. First issue I have is '... any serious incident that has occurred in relation to the device ..' needs to be used with a lot of caution (no pun intended). What is a serious incident for your device? Does the users of medical devices in Europe know the definition of 'serious incident'? What would be a serious incident that is reportable? Any complaint with a device should be reported to the manufacturer, then the manufacturer should make the determination whether the incident is serious or not serious. This statement is leading to the fact all known and unknown serious incidents with a medical device needs to be stated in the Instructions for Use. Personally, I do not know of a medical device company divulging that information. Maybe there is some Warnings and Cautions associated with the device, but a statement such as, 'If this device kills the patient, please report it to us at phone number +534 123 2345.' Who would put a statement like that in their IFU?
The second issue I have is, '... reported to the manufacturer
and the competent authority of the Member State ...' because there are Member States not having methods where public health institutions, hospitals, or public could report serious incidents. What you are telling me is Alik a nurse at a hospital in Finland knows the contact number from here
https://ec.europa.eu/growth/sectors/medical-devices/contacts_en and who to contact? Maybe this information is contained in the hospital's internal records - that is well a good, but tell me about lay-person use products. Now we talk about Ms. Stehler from Helsinki who's at-home monitoring device fails knows when this represents a serious incident and they have the email readily available to contact Valvira (Finland)? Not likely. Thus the word 'and' have concerns with this that from my perspective complaints including any serious incidents should flow through the manufacturer.
Dan is right under Article 87 now that when Competent Authorities become aware of serious incidents or potentially reportable incidents, these must be communicated to the manufacturer. However, unless the Competent Authority has a system set up like MHRA in UK, this does not seem realistic to me for all 28 member states. From my perspective these will not necessarily be isolated incidents, but when Competent Authorities are doing market surveillance they become aware of issues with a device, they will then contact the legal manufacturer. Again pose the scenario: Ms. Stehler in Finland knows who to contact at the Finnish health authorities when she has determined that her medical device represents a serious incident to her health?
What I would personally recommend is just having a statement if there is issues with quality, durability, usability, reliability, etc., i.e. from the complaint definition, that customers should contact Manufacturer X at phone/email. Until a Notified Body reviewer states the exact terminology to use in the Instructions for Use, I would refrain from making copied statements from the regulation as clearly a mine-field for the reasons stated above.
------------------------------
Richard Vincins RAC
Vice President Global Regulatory Affairs
------------------------------
Original Message:
Sent: 09-Jul-2019 20:00
From: Dan O'Leary
Subject: Support to identifying a common statement in labelling for products sold in EU region and US(MDR purpose)
Do not forget to set up the system required by Art. 87(11) so you will be prepared if a competent authority receives a report and sends it to you. This is part of the vigilance system and, consequently should be covered in the QMS.
I recommend an SOP to deal with the situation. For a reportable serious incident, send it to the Art. 87 reporting system. If not be prepared to provide the reason to the CA and enter the report into the Art. 88 Trend Reporting system. Also, cover the case where the CA disagrees.
------------------------------
Dan O'Leary CQA, CQE
Swanzey NH
United States
Original Message:
Sent: 09-Jul-2019 17:28
From: Dan O'Leary
Subject: Support to identifying a common statement in labelling for products sold in EU region and US(MDR purpose)
Even for the EU, the term "regional competent authority" is not correct. The competent authorities are not regional, but by member state. The best method, in my opinion is to use the Annex I wording as written. However, I would consider a slight modification for clarity outside the EU.
"In the event of a serious incident, notify XXX and the competent authority of the EU Member State."
------------------------------
Dan O'Leary CQA, CQE
Swanzey NH
United States
Original Message:
Sent: 09-Jul-2019 17:12
From: Vadivelan Dharanisingh
Subject: Support to identifying a common statement in labelling for products sold in EU region and US(MDR purpose)
Hi Team,
MDR 23.4(z) requires a statement to be mentioned in the label in the event of serious incident. We decided to add "In the event of a serious incident, notify XXX and your regional competent authority". But most of our CE marked products sold globally other than EU region, they were concerns raised in adding "competent authority" because other countries such as US might not be familiar with competent authority or doesn't have one.
Can you please suggest an alternate options or Please advise in keeping "competent authority" would be more than enough for other countries such as US.
------------------------------
Vadivelan Dharanisingh
Product Regulatoy Lead
------------------------------