IS there any database for list of CE marked Medical devices and there current status
- Thread starter Harini17
- Start date
Re: IS there any database for list of CE marked Medical devices and there current sta
Such a database does not exist.
But it will be introduced by the incoming Medical Device Regulations.
But this database (EUDAMED) will not be publicly accessible. Instead, only the EU national regulators will have access.
Such a database does not exist.
But it will be introduced by the incoming Medical Device Regulations.
But this database (EUDAMED) will not be publicly accessible. Instead, only the EU national regulators will have access.
Re: IS there any database for list of CE marked Medical devices and there current sta
Curious: what is the rationale here?
I can't think of any reason why you wouldn't open the listings to the public, aside from maybe logistics such as ensuring appropriate front-end and bandwidth.
It seems natural that the public may want to use such a listing to verify that the device they are using/purchasing is compliant.
Curious: what is the rationale here?
I can't think of any reason why you wouldn't open the listings to the public, aside from maybe logistics such as ensuring appropriate front-end and bandwidth.
It seems natural that the public may want to use such a listing to verify that the device they are using/purchasing is compliant.
J
Johnny_Bravo
Re: IS there any database for list of CE marked Medical devices and there current sta
There are numerous instances in the MDR&IVDR which state that data entered in EUDAMED shall be accessible to the public. In fact, it is one of the purposes of the database - recital 44: "The objectives of the database are to enhance overall transparency, including through better access to information for the public and healthcare professionals, to avoid multiple reporting requirements, to enhance coordination between Member States and to streamline and facilitate the flow of information between economic operators, notified bodies or sponsors and Member States as well as between Member States among themselves and with the Commission."
There are numerous instances in the MDR&IVDR which state that data entered in EUDAMED shall be accessible to the public. In fact, it is one of the purposes of the database - recital 44: "The objectives of the database are to enhance overall transparency, including through better access to information for the public and healthcare professionals, to avoid multiple reporting requirements, to enhance coordination between Member States and to streamline and facilitate the flow of information between economic operators, notified bodies or sponsors and Member States as well as between Member States among themselves and with the Commission."
Re: IS there any database for list of CE marked Medical devices and there current sta
As Johnny has highlighted there are changes happening to Eudamed, brought in by the move to the Medical Device Regulations.
Eudamed has actually been around for some time (~2009) but has been limited to the regulators.
But the 'new' one will be better!
This is from Emergo (trusted source); see here:
Eudamed to change along with European CE Mark regulations for medical devices
So Joe Public will be 'allowed' by those-who-we-must-obey to have access - but only to some parts.
As Johnny has highlighted there are changes happening to Eudamed, brought in by the move to the Medical Device Regulations.
Eudamed has actually been around for some time (~2009) but has been limited to the regulators.
But the 'new' one will be better!
This is from Emergo (trusted source); see here:
Eudamed to change along with European CE Mark regulations for medical devices
So Joe Public will be 'allowed' by those-who-we-must-obey to have access - but only to some parts.
RobertvanBoxtel
Involved In Discussions
Re: IS there any database for list of CE marked Medical devices and there current sta
One of the publicly accessible parts will be Section 1, Part 1 of Annex VI.
(see article 31.7).
This means that the following information will be made public:
1. Information relating to the economic operator
1.1. type of economic operator(manufacturer, authorised representative, or importer),
1.2. name, address and contact details of the economic operator,
1.3. where submission of information is carried out by another person on behalf of any of the economic operators mentioned under Section 1.1, the name, address and contact details of that person,
1.4. name address and contact details of the person or persons responsible for regulatory compliance referred to in Article 15.
It does not identify to the public which devices are placed on the market. But it does identify the PRFRC. Are you willing to fullfill that role? And potentially find the media at your doorstep in case of issues published on the products in your company?
One of the publicly accessible parts will be Section 1, Part 1 of Annex VI.
(see article 31.7).
This means that the following information will be made public:
1. Information relating to the economic operator
1.1. type of economic operator(manufacturer, authorised representative, or importer),
1.2. name, address and contact details of the economic operator,
1.3. where submission of information is carried out by another person on behalf of any of the economic operators mentioned under Section 1.1, the name, address and contact details of that person,
1.4. name address and contact details of the person or persons responsible for regulatory compliance referred to in Article 15.
It does not identify to the public which devices are placed on the market. But it does identify the PRFRC. Are you willing to fullfill that role? And potentially find the media at your doorstep in case of issues published on the products in your company?
J
Johnny_Bravo
Re: IS there any database for list of CE marked Medical devices and there current sta
I probably didn't capture everything in the first reading but it is a bit more than Section 1, Part 1 of Annex VI.
- Part B of Annex VI (UDI database)
- Section 1 of Part A of Annex VI
- Summary of safety and clinical performance for implantable and for class III devices.
- Some information on clinical investigations (with few exceptions: MS and COM information exchange, personal data, commercially confidential information ...)
- Summary and clinical investigation report
- Information regarding certificates issued, including amendments and supplements thereto, and regarding suspended, reinstated, withdrawn or refused certificates and restrictions imposed on certificates
- Field safety notices
If it was just Section 1 of Part A of Annex VI, the purposes of EUDAMED with regard to public access (Article 33.) would remain unmet:
- "to enable the public to be adequately informed about devices placed on the market, the corresponding certificates issued by notified bodies and about the relevant economic operators";
- "to enable the public to be adequately informed about clinical investigations ..."
"The Commission shall ensure that public parts of Eudamed are presented in a user-friendly and easily-searchable format."
I probably didn't capture everything in the first reading but it is a bit more than Section 1, Part 1 of Annex VI.
- Part B of Annex VI (UDI database)
- Section 1 of Part A of Annex VI
- Summary of safety and clinical performance for implantable and for class III devices.
- Some information on clinical investigations (with few exceptions: MS and COM information exchange, personal data, commercially confidential information ...)
- Summary and clinical investigation report
- Information regarding certificates issued, including amendments and supplements thereto, and regarding suspended, reinstated, withdrawn or refused certificates and restrictions imposed on certificates
- Field safety notices
If it was just Section 1 of Part A of Annex VI, the purposes of EUDAMED with regard to public access (Article 33.) would remain unmet:
- "to enable the public to be adequately informed about devices placed on the market, the corresponding certificates issued by notified bodies and about the relevant economic operators";
- "to enable the public to be adequately informed about clinical investigations ..."
"The Commission shall ensure that public parts of Eudamed are presented in a user-friendly and easily-searchable format."
Raisin picker
Quite Involved in Discussions
If you want to verify a specific device (class > I), you can start with the manufacturers HP. With some luck, you can find the notified body number/name and check with the NB directly. They should have a list of valid certificates available. This will most likely not identify a specific model, but at least a scope.
I don't think you can get better than that at the moment, but please prove me wrong.
I don't think you can get better than that at the moment, but please prove me wrong.