You may wonder what you would do if your company was in the unfortunate position of ceasing to trade or even bankruptcy, what it means for the business and whether it applies to your organisation. If your company aims to or already complies with the EU Medical Device Regulation (MDR) 2017/745 or EU In Vitro Diagnostic Regulation (IVDR) 2017/746, you need to know the regulatory requirements associated with ceased trading, including bankruptcy.
The MDR and IVDR stipulate administrative provisions which define a list of documents to be maintained in the event that a medical device company is no longer trading.
Annex IX – Conformity Assessment based on a Quality Management System and on Assessment of Technical Documentation, Chapter III- Administrative Provisions of the MDR/IVDR stipulates: “Each Member State shall require that the documentation referred to in Section 6 is kept at the disposal of competent authorities for the period indicated in that Section in case a manufacturer, or its EU authorised representative, established within its territory goes bankrupt or ceases its business activity prior to the end of that period.”
What does this mean exactly?
As a medical device company, you are responsible for ensuring that any technical documentation relating to your products and Quality Management System (QMS) documentation is retained should your business go bankrupt or cease trading.
What documents do you need to retain?
Here is a list of the type of documents that should be retained. Note that this is not an exhaustive list:
- The EU Declaration of Conformity.
- The technical file documentation applicable to your devices.
- The QMS includes the quality manual, procedures, policies, etc., that are applicable to your organisation and device(s).
- Documentation relating to substantial changes made under the QMS, including evidence that the notified body has been informed of these changes.
- Notified body and unannounced audit plans, reports and other audit-related documentation.
How long do you need to retain these documents for?
The retention period for retaining documentation after the company ceases trading is defined below and applies after the last device was placed on the market:
EU MDR 2017/745
10 years for general medical devices
15 years for implantable devices
EU IVDR 2017/746
10 years
Who is responsible for holding the documentation after the company ceases trading?
It’s up to your business to decide who will be responsible for retaining the documentation. Still, it is good practice to plan accordingly and set funds aside early on when business is trading, as usual, to allow you to pay your appointed EU Authorised Representative (EUAR) or an external consultant to retain the documents on your behalf, should the competent authority request to see these in the future.
Who needs to be informed?
When it comes to bankruptcy, it can be difficult to understand who needs to be notified. Below is a list that defines who should be informed in the event your organisation should go bankrupt. This list is not exhaustive, and any other interested parties should also be considered:
- Notified body
- The competent authority that your devices are registered with
- An appointed solicitor
- Your appointed EUAR
- Insurance companies
- Affected customers
- Importers and distributors
LFH Regulatory can help…
LFH Regulatory have a team of experts who can assist you with making sure you have the appropriate contingency plan in place. Contact us today at +441484662575 or via info@lfhregulatory.co.uk to see how we can help.
References
- EU In Vitro Diagnostic Regulation (IVDR) 2017/746 of the European Parliament and of the Council of April 5, 2017, on in vitro diagnostic medical devices
- EU Medical Device Regulation (MDR) 2017/745 of the European Parliament and of the Council of April 5 2017, on medical devices
