The MDR Compliance Checklist

You must check that all staff members involved in the production/distribution/provision of your devices are recorded.

You must check that all personnel involved in the production, storage and distribution of orthopaedic technical devices are sufficiently competent and experienced to ensure that orthopaedic technical devices are stored and managed correctly. Furthermore, you need to check that all staff members have received training appropriate to the tasks assigned and the training received has been recorded in a logbook.

You must identify a quality manager to be the contact referent in terms of material-vigilance and write it down in the organigram.

You must provide documentation that shall contain all the activities described and is written in a language that the staff can understand. Documentation should also contain instructions for critical activities which have a direct or indirect influence on the quality of the orthopaedic technical device.

The quality manager must sign and date all changes to the documentation. The changes are arranged in such a way that the original information remains legible, and the reason for the changes is specified.

You must give each employee access to all the necessary documentation relating to the tasks carried out under the responsibility.

You must adjust the documents in line with their development and keep those documents for at least 5 years. You must ensure that theses documents are immediately available to the competent authorities.

You must publish all your processes on the FAMHP website, and other critical processes should be available.

You must maintain records with clear annotations so that all activities or significant incidents can be traced whenever an activity (production, purchase and sale, maintenance and control of storage premises, complaints, returns and recalls) is carried out.

You must keep records for any purchase or sale transaction (with the exception of direct sales to individuals) during production and/or distribution.

You must store orthopaedic technical devices under the manufacturer's conditions and those of the FAMHP. You are subject to regular audits. Corrective measures can be taken in the event of deviations.

You must put a system in place to organise the renewal of stocks, and if possible, the products that expire first are released first. The proper functioning of this system is checked at appropriate and regular intervals.

You must organise the warehouse in such a way that there is a clear separation between orthopaedic devices intended for purposes other than sale and sellable stock, goods in quarantine, returned goods, recalled goods, destroyed goods, goods awaiting VAT control, for demonstration equipment, for samples, for rental, for calibration of equipment, etc.

You must separate physically orthopedic technical devices and intermediate products whose expiry date has passed from the stock approved for sale and not delivered.

You should protect unloading sites from the weather during unloading.

You must separate the reception area from the storage area in order to make a visual distinction between, on the one hand, products that have just been delivered and still need to be checked and, on the other hand, products that have already been approved and are in stock.

You must ensure that you obtain supplies from a legal manufacturer, a supplier registered with the AFMPS or from the list of non-registered products

You must examine your products on receipt. For large orders, a random sample is taken and used for the quality check.

You shall immediately separate non-conforming or counterfeit intermediate products and orthopaedic devices from the sellable stock and shall inform the manufacturer and the national authority.

The quality manager must determine and document subsequent actions. You may only return to sellable Orthopedic technical devices that have left the control of the distributor/manufacturer if you respect the following :

You must have free access to all declarations of conformity and, where applicable, CE certificates of the orthopedic technical aids that you produce, distribute and/or sell.

You must transport orthopedic devices  under the conditions prescribed by the manufacturer. The mode of transport must not affect the quality of the orthopedic devices. For the transport of custom-made work, the transport conditions prescribed by the manufacturer must also be defined in such a way that the mode of transport does not adversely affect the quality of the technical orthopedic devices.

You must attach to each delivery of custom-made, including modification on prefabricated units:

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You must record for custom-made, prefabricated modification and distribution the important activities and events during manufacture (placing in stock, consignment or receipt, returns, reminders, samples, lending of demonstration equipment, equipment rental, etc.)  so that the origin and destination of the orthopaedic devices can be found, both for domestic and foreign deliveries.

The traceability system is tested annually on the basis of a simulation. The report of this annual action is documented and available.

You must mark technical orthopaedic devices returned by customers and place them in quarantine pending further examination or collection by the distributor/manufacturer.

The medical device returned is indeed the medical device previously sold and this has been proven via a check of the batch/serial number and expiry date.

Orthopaedic technical aids are only released (under delegation or not) under the responsibility of the quality manager to be included in the sellable stock and are therefore added to the sellable stock.

You must maintain records of returned medical devices. For each return, the documentation must contain the following information:

You must record all oral or written complaints submitted in order to assess complaint trends, the regularity of product quality-related complaints and the seriousness of the complaints, with a view to taking further action and, if necessary, immediate corrective measures. You must keep these records available for inspection by the competent authorities.

Records of complaints must include the following information:

The material-vigilance contact point within the company is required to ensure that the manufacturer/distributor and the FAMHP are directly informed of any incident, including recalls concerning the orthopaedic technical devices that it distributes. The attached decision tree makes it possible to determine whether an incident must be notified to the FAMHP (in Belgium). All (suspected) incidents must be reported to the manufacturer or his authorised representative. Any communication to the FAMHP regarding incidents must be made via the address meddev@fagg-afmps.be (general e-mail address for medical devices in Belgium) using the standard form published on the FAMHP website