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MDR ARTICLE 120(3) TERMS AND CONDITIONS

It would seem like there will be a considerable number of medical devices compliant with the MDD on the market after 26 May 2020. To compensate, the Article 120(3) of the MDR requires that such devices opting for this ‘legacy route’ meet certain conditions:

From 26 May 2020:

  • The device continues to comply with the Directive.
  • There are no significant* changes in the design or intended purpose.

Furthermore, the requirements in the MDR related to the following shall apply:

  • Post-Market Surveillance [Article 83-86, 92, Annex III]
  • Market Surveillance [Article 93-100]
  • [Article 87-92]
  • Registration of economic operators and devices [Article 31 and 29]

* The MDCG have produced guidance on significant changes, please see this link.

Whether a change in design or intended purpose may be considered as significant shall be determined on a case by case basis, however, the following changes shall not be considered to be significant:

  • Reductions or limitations of the intended purpose.
  • Design changes related to corrective actions assessed and accepted by the Competent Authority.

The Notified Body who has issued the AIMDD/MDD certificate shall continue to be responsible for the surveillance relating to the devices it has certified.

Medical Device Reclassifications or Up-Classifications: Devices that Currently do not Require a CE certificate

There are several devices that currently do not require a CE certificate under the Directives, which will need certification under the EU MDR by 26 May 2020 for continued market access. This may be due to up-classifications (e.g. some software that is currently Class I under MDD but are Class IIa or higher under MDR) or due to changes in the scope of the legislation (e.g. devices that contain non-viable derivatives of human tissues or cells, which are covered by MDR, but outside the scope of current device directives).

If you have any such devices within your portfolio and need assistance in upgrading your files and submission to your notified body, please do not hesitate to contact us.

Email: info@advenamedical.com

Medical Device Regulation (MDR) EU Regulation – Class I Reusable Surgical Instruments

Manufacturers of Class I Reusable Surgical Instruments must now obtain a CE certificate under Annex IX Chapters I & III or Annex XI – Part A (limited to the re-usability aspects, as appropriate) by no later than May 26th, 2020 for these devices.

Failure to do so will exclude them from placing these devices on the EU market from May 26th, 2020 onwards or until you achieve CE certification.

To be clear your current medical device registration (MDD) will become invalid on May 25th, 2020. You must act now if you wish to continue to CE mark and supply these devices.

Remember, while Notified Body CE certification is limited to the aspects concerning the reusability of your devices, all your technical documentation must also be upgraded to comply with the MDR and Advena can assist with the technical file upgrades.

Time is now running out and there are only two Notified Bodies currently designated to MDR (BSI UK & TUV SUD). The EU Commission have promised that more will be available by the end of the year, therefore, it makes sense to begin the process of upgrading your technical documentation/files now. So, you need to instruct your regulatory team to begin preparations, if you don’t have the resources internally please do not hesitate to contact us, as mentioned above, we can help!

Email: info@advenamedical.com

Using Distributors and Importers as an EC REP and Data Security.

Over the years we have expanded our comprehensive European Authorised Representative services to many non-EU manufacturers who have traditionally used EU importers and distributors for this role.  Now, and particularly with the new EU device regulations looming that require data sharing, perhaps the time may be now to ask the question;   “Can you trust your importer or distributor with your intellectual property”?

This is an especially critical issue for new and innovative technology. Advena already operates a best practice approach treating client data as confidential, to reinforce this we encourage the use of non-discloser agreements, whereas others such as distributors may not always act in the manufacturers best interests and therefore, may not be so diligent.

When a device manufacturer works with Advena all confidential documents, manuals, certificates, dossiers and project related files are only stored on our secure password protected server that is accessible only to employees who are subject to stringent confidential agreements.

Client confidential data would never be archived on laptop computers that could be lost or stolen.

The new medical device regulation (MDR) stipulates that the manufacturer shall in order to allow its Authorised Representative to fulfil its tasks ensure that the necessary documentation is permanently available. This will be very important in the future where EU Authorised Representatives will be legally required to be able to access manufacturer’s compliance data.

So the question is, do you really want your distributor or importer to have permanent access to your sensitive technical data?

If you currently use a distributor or importer as your EU Authorised Representative, this is a subject worth some serious consideration.

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