We comply with the MDR
Medical devices are used to benefit patients for therapeutic or diagnostic purposes. A medical device is defined as being a straightforward patch but also a complex medical device or implant such as an artificial hip joint. The manufacturers of all medical devices have long had to comply with legal and normative requirements. In Germany, the details are regulated in the Medical Devices Act. This in turn implements European requirements, which are laid down in a European directive (Medical Device Directive or MDD for short).
The requirements of this directive must be implemented by each country in its own national laws. The European Directive describes that a medical device placed on the market in the EU must meet certain requirements. Details of what these are depend on the risks that can originate from the individual product. The more complex a product, the more detailed the requirements. To facilitate the classification of products, they are assigned to risk classes. For higher classified products, the manufacturer must provide detailed evidence to his Notified Body (inspection body) that all requirements have been met. The manufacturer may then affix a CE mark to his product and offer it freely on the market anywhere within the EU, or in other words "place it on the market". For lower-risk products (e.g. Class I products), this lies within the manufacturer's own responsibility.
On May 26th, the old European directive MDD will be replaced by a new regulation, the Medical Device Regulation, or MDR for short. Unlike the directive, this regulation does not have to be implemented in national laws, but is immediately uniformly legally valid and binding for all European member states.
1: Article number
2: Batch number
3: Date of manufacture
4: Expiry date
7: Date of manufacture
8: Expiry date
You will probably not even notice most of the changes. The focus is on internal processes and their organisation. Almost everything concerning the MDR happens in the background. However, with the new regulation coming into force in May 2021 and the introduction of an associated new labelling obligation, the so-called UDI (Unique Device Identification), the label on our products will change. Further to the usual information such as the article number, article name or manufacturer, a new 14-digit number under a scannable Data Matrix has been added.
The number as well as the matrix contain all important information in a scannable code to be able to trace each medical device in detail. This unique, internationally standardised identification of medical devices over the entire life cycle offers clear advantages: error-free and fast recording in the manufacturing process, in the warehouse, during order picking and in shipping. Above all, for you as a user it means complete traceability of your product and thus additional transparency and security.
What do the new MDR guidelines mean for the FAHL company and how are these measures implemented within the organisation?
Our Quality Manager Christa Peters sums it up in a nutshell.
Andreas Fahl Medizintechnik-Vertrieb GmbH is ready to face these new challenges of the MDR and welcomes the new guidelines for increased patient safety. And of course, we will continue to offer the entire product
portfolio on the market under the new approval procedures. We have dedicated teams in the areas of quality management and product development, which we are constantly training so that the new requirements can be
implemented in a targeted manner. Our long-standing Notified Body is already accredited for auditing according to the MDR and will audit us according to the new regulation for the first time later this year. Patient safety
will continue to be our focus in the future.
What is the MDR?
The MDR (Medical Device Regulation) is a new regulation of the European Union for more patient safety. It replaces the old European Directive MDD (Medical Device Directive). Several hundred pages describe changes that affect all medical devices, but also changes that only formulate new specifications for certain product groups. To summarise, all manufacturers of medical devices are now obliged to:
- expand the documentation of product-related data,
- intensify cooperation with suppliers and monitor them more closely,
- change the classification of products such as software into higher risk classes,
- introduce monitoring of products on the market throughout the life cycle of the product and, as a result, to regularly reassess the safety of the product.
After expiry of the extended transition period (for higher classified devices with a valid MDD certificate), every medical device must comply with the MDR requirements by 27.05.2024 at the latest. Some experts and critics see a danger in that some established and proven products could disappear from the market due to the significantly increased requirements of the new legislation. This applies in particular to niche products with which manufacturers are present on the market to a moderate extent, but which require the same amount of effort as a mass-produced product once the MDR has been introduced.