CE Marking Checklist Technical File Under MRA

[Nash27]

We are planning to get CE marking for existing supplied product in Australia under the mutual recognition agreement between EU and Australia. I am just wondering if anyone have a checklist that describes important documentation as part of the technical file of the device such as ER checklist, clinical evidence, risk management, device incidents and reporting etc. The supplied device is classified as sterile Class IIa as per the TGA regulations. If someone could help that would be great. Thanks

 

[Ronen E]

Hi,

The ARGMD (p. 130) reads:

MRA certificates of conformity issued by the TGA
Australia has signed a Mutual Recognition Agreement (MRA) with the European Union (EU) and the European Free Trade Association (EFTA), covering several industry sectors including the medical devices sector. For more information on MRAs please see Section 9. International agreements.
Under the MRAs, the Australian Government has designated the TGA as the Conformity Assessment Body responsible for assessing devices manufactured in Australia to the requirements of the Medical Devices Directive and the Active Implantable Medical Devices Directive. Australian manufacturers who receive a MRA certificate from the TGA are then able to affix the CE Mark and supply in Europe.
However, the TGA can only issue EC certificates to manufacturers established within Australia or New Zealand. For a manufacturer to be eligible for an EC certificate under the Australia-EU/EFTA MRAs the manufacturer must demonstrate that the device is fully (or mostly) manufactured within Australia and/or New Zealand. Some kinds of devices are also excluded from the agreement, or are subject to confidence building activities.
EC MRA certificates are not issued by the TGA in accordance with the Therapeutic Goods Act 1989, but are covered by a contractual arrangement between the manufacturer and the Commonwealth of Australia (which is represented by the TGA). The TGA issues EC certificates under the MRAs as an extension to an application for an Australian TGA Conformity Assessment Certificate.
An application for an EC certificate is submitted with an application for a TGA Conformity Assessment Certificate. The TGA conducts both assessments at the same time as the requirements are similar but there are some differences. If the applicant is issued with a TGA Conformity Assessment Certificate and is found to also satisfy the additional EU/EFTA requirements, the TGA will issue an EC certificate. Additional fees are payable for this assessment. For more information please see Section 2. Fees and charges for medical devices.
If a manufacturer intends to obtain EC certification from the TGA, it is important that they establish an European Representative in the EU/EFTA and seek advice on the particular requirements applying to the EU/EFTA area/state where they intend commercialising the medical device.
Manufacturers should obtain a copy of the relevant EU Directives before applying to the TGA for EC certification. More information on the European requirements can be obtained from <http://www.newapproach.org/Directives/DirectiveList.asp>.

If you already hold a class IIa conformity assessment certificate from the TGA, I suggest you apply for an EC certificate from the TGA, under the MRA, without any additional preparation; it's likely that they would issue an EC certificate (the TGA has an EC NB status) based on the information they already have, assuming that it's current. Otherwise, they will let you know if anything is missing.

Cheers,
Ronen.

PS You might also want to review the MRA amendments from January 2013 (please also note that the 2-year confidence-building period is about to end - January 2015; this may or may not be relevant to your device).

 

[MIREGMGR]

Interesting program.

I assume that TGA does periodic microbiologist audits of AUS/NZ sterilization providers and device makers that offer terminally sterilized devices...?

US FDA's MDSAP is another mutual recognition program involving TGA. Has TGA published a similar description of how their end of that program will work?

 

[Ronen E]

I assume that TGA does periodic microbiologist audits of AUS/NZ sterilization providers and device makers that offer terminally sterilized devices...?

The TGA holds periodic surveillance audits of Australia-based device makers, similar to those NBs hold, to maintain vaidity of certificates where applicable. Microbiological aspects are included as applicable to the devices and the operations being audited.

US FDA's MDSAP is another mutual recognition program involving TGA. Has TGA published a similar description of how their end of that program will work?

I'm not aware of any detailed instructions published by the TGA to date, in that regard (they are a bit slow in general). This TGA web page, last updated in October 2014, states:

Medical Devices Single Audit Program (MDSAP)

With the United States Food and Drug Administration, the Brazilian Health Surveillance Agency and the Health Canada Health Products and Food Branch, the TGA is developing MDSAP for implementation from 2015. Through this platform the parties will strengthen cooperation in the scientific and regulatory area of medical devices. The implementation of the program should allow for a single audit to satisfy the regulatory requirements of participants.

The external handle in that text points to the IMDRF website (AFAIK the TGA is a strong promoter of the IMDRF initiative, as it has been with the GHTF).

 

[Nash27]

Hi Ronen, Thanks for your information. Application of MRA is not straight forward as it seems considering TGA would like to review the compliance against the EU requirements i.e. Organisation has undergone substantial review of the EU requirements such as verified essential requirements against the essential principles, device classification differences, label requirements, established process that meets the EU device incident reporting and device recall procedures etc. I have figured way around now for the checklist, hopefully I will post it on elsmar by early next year.

MIREGMGR: About the Medical Devices Single Audit Program (MDSAP) I have attended the TGA informative session in June 2014 and it appears that what Ronen is saying is confirm, however implementation of the agreement would be likely to implement in somewhere in 2016 as so far only one consturctive meeting was held between TGA and FDA

 

[Ronen E]

Hi Ronen, Thanks for your information. Application of MRA is not straight forward as it seems considering TGA would like to review the compliance against the EU requirements i.e. Organisation has undergone substantial review of the EU requirements such as verified essential requirements against the essential principles, device classification differences, label requirements, established process that meets the EU device incident reporting and device recall procedures etc. I have figured way around now for the checklist, hopefully I will post it on elsmar by early next year.

MIREGMGR: About the Medical Devices Single Audit Program (MDSAP) I have attended the TGA informative session in June 2014 and it appears that what Ronen is saying is confirm, however implementation of the agreement would be likely to implement in somewhere in 2016 as so far only one consturctive meeting was held between TGA and FDA

Thanks for sharing.

Have you discussed your situation in specific with a TGA official? The way you present it, it doesn't make too much sense to me - if that is the case then what good is the MRA?... It sounds like a no-concession path to EC certification with the TGA playing the NB role, so why bother?... You could just as well go with any NB who operates in Australia. The way I understand the MRA's provisions, the TGA is supposed to grant an EC certificate based on the existing clearance in Australia, which they've already granted. The base assumption for the whole MRA is that requirements in Australia and in the EC are equivalent (i.e. the differences are immaterial) therefore a device cleared in Australia is good enough for being placed on the EC market, mostly as-is. The EC certification under the MRA is supposed to be a mostly-administrative process, not another full-scale assessment by the TGA. Gap closing would make sense only if very substantial issues are identified.

Cheers,
Ronen.