From EEC to EU - A brief history of European medical device regulations
Times are changing, and so are the regulations. Before the European Regulation 2017/745 on Medical Devices, the MDR, defined the requirements for medical devices in 2017, this role was fulfilled by Directive 93/42/EEC, commonly known as the MDD.
The MDD (Medical Device Directive) and MDR (Medical Device Regulation) thus had very similar objectives, but differ fundamentally in important respects – from the legal format to the scope of the regulations and the structuring of the regulatory infrastructure.
The case law, requirements and indeed the entire substructure of the broad market of medical devices has changed since 2017. Nevertheless, there are many products that are still used by loyal customers, whose production chains are still in place, or for which there are still warehouses full of spare parts.
The manufacturers of these products often want to continue to enable their customers to use their products without restriction. As a result, BEO BERLIN is often asked whether accessories or spare parts for MDD-Products can still be imported in the age of MDR.
To answer this question, it makes sense to look at the MDR-Provisions for the following terms.
- Medical Device: Every Medical Device must be labelled with the CE mark before it can be placed on the market. This means that it must meet the current requirements of the applicable legal basis. For the EU, this has been the MDR since 2017.
- Component for a medical device: These must also bear the CE label before they can be sold.
- A part/component: Is intended for the replacement of existing components of a product that has already been found to comply. They are not considered to be medical devices and therefore do not require their own CE label.
Attentive readers will have noticed the difference between medical devices/accessory parts on the one hand and parts/components on the other. This distinction also arises from the MDR, more precisely from Article 23 of the EU-MDR or Article 12 of the Swiss MDR. It says:
“The characteristics and performance of the device must not be adversely affected to such an extent that the health or safety of the patient, user, or, where applicable, others is compromised during the device’s lifetime, provided the device is subject to stresses which may occur under normal conditions of use and has been properly maintained in accordance with the manufacturer’s instructions” (EU-MDR, Art. 23, GSPR 6).
In other words, this means that manufacturers are responsible for the safety and performance of a device until the end of the device's life cycle, even if the device is to be taken out of service (for example, because it no longer meets the requirements of the MDR).
If the manufacturer has already supplied spare parts for the MDD-compliant product in the past, they can continue to supply the spare parts for the products still on the market until the end of their service life, even if the product itself has not been converted to MDR.
In other words, this means that manufacturers are responsible for the safety and performance of a device until the end of its life cycle, even if the device is to be taken out of service (e.g. because it no longer meets the requirements of the MDR).
In short: As long as the safety and performance of a product remain guaranteed, spare parts may continue to be supplied, even if the original product is not MDR-compliant.
We are happy to assist you as a reliable partner. Please do not hesitate to contact usif you have questions about the MDR- or MDD-Regulation or need support in complying with regulatory requirements.
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