Hello Anon,
There needs to be a differentiation between "placing on the market" and "putting into service" as these can be different points in the distribution cycle of the device. If placing on the market means these products are located in a distributor warehouse, then they should not be put into service if the CE Mark has expired. These products should be retrieved from the distribution point and not "sold" if the CE certificate has expired. If the products have been put into service, meaning sold to the end user, then the CE certificate expiration does not have an impact for product already put into service.
Therefore, answering your question of what documentation in place of the CE Certificate would be provided to a healthcare facility: there is no documentation which could be provided, because if the CE Certificate is expired means the product should not be sold. This is the point of being CE Marked and having legislation defining the requirements. Recommend reviewing the Blue Guide about placing on the market and putting into service in relation to the legislative requirements.
For products which are already put into service, such as instruments or reusable devices, as long as the product was put into service prior to the CE Certificate expiring, the products can continue to be used. However, now this gets into supporting post market activities for products where a Declaration of Conformity has been cancelled or no longer valid. This is a legitimate question to be asked by a Notified Body auditor as the company needs to have a life cycle plan identified for products continuing to be used on the market which are no longer sold. In most cases, this would be an "end of life" quality plan for a product where the company no longer plans to sell product or maybe in this situation a quality plan to cover a transition between expired certificate and resumption of selling the product. Without knowing the type of product, this may need to be addressed in different ways from reusable product to product with a short shelf life to product with a long shelf life.
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Richard Vincins RAC
Vice President Global Regulatory Affairs
Oriel STAT A MATRIX - ENTERPRISE
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Original Message:
Sent: 08-Jun-2021 02:43
From: Robert van Boxtel
Subject: Taking part to tenders with an expired CE certificate - EU market
A question to you first: would you be able to fulfill the requirements of the tender for the time period identified in the tender with the stock that is in place of the products with expired certificate?
If so, the only option you have is explaining the status of the product, provide a declaration of conformity to that end and a description on how you would commit towards servicing activities (when applicable) and PMS. Alternatively, you can approach the competent authority to request under article 59 a local approval.
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Robert van Boxtel
Principal Consultant Medical Device Project B.V.
MDProject
Alphen a/d Rijn
Netherlands
Original Message:
Sent: 07-Jun-2021 09:33
From: Anonymous Member
Subject: Taking part to tenders with an expired CE certificate - EU market
This message was posted by a user wishing to remain anonymous
Dear all,
how would you handle the participation to tenders with a device whose CE mark is expired?
I am talking about units that have been placed on the market before the expiration date of the CE.
What documentation - in place of the CE certificate - would you provide to the procurement department of healthcare facilities when taking part to such tenders?