When it comes to medical devices, quality and safety are especially vital. As a notified body, we can help you with your conformity assessment procedure and ensure that your active and non-active medical devices comply with EU Directive 93/42/EEC. Tap into the European market!
Product tests and certifications by TÜV Rheinland let you:
As a manufacturer of active and non-active medical devices, you cannot market your products on the European market unless you meet the basic requirements EC Directive 93/42/EEC (MDD), Annex I.
Every manufacturer must define the intended purpose of their medical devices and classify them based on Annex IX of Directive 93/42/EEC on medical devices. The directive distinguishes between four risk classes (class I, class IIa, class IIb, and class III).
Classification may be based on the following criteria:
Depending on the classification of your medical device, your conformity assessment procedure may have to be conducted by a conformity assessment procedure.
The following assessment modules are available:
The company DuPontTM has transitioned Tyvek® 1073B and Tyvek® 1059B to a new manufacturing process. Legal Manufacturers of medical devices who use this material in their products should assess the packaging and sterilization processes to evaluate the impact on their devices. TÜV Rheinland LGA Products GmbH developed the following guidance (PDF, 99 KB) to show in which case the significant change for CE0197 labeled devices is reportable. We would therefore recommend to send us the Significant Change Notification Form (PDF, 84 KB) back.
Further information can be found under: www.dupont.com
All medical devices that have electronic features or that interact via radio (i.e. wirelessly) are exposed to the threat of hacking or failure. Past cases have been reported in which pacemakers were hacked or computer programs that control medical devices crashed during an examination or an operation, for instance. An additional risk is posed by the confidential patient data that is typically stored and transferred electronically nowadays. Data business is generally booming, which inevitably results in misuse as well. Devices that store patient data are thus at risk for cyber attacks. Personal tablets and smartphones are also exposed to this risk. Today's blood pressure monitors can connect to apps installed on mobile devices and export readings so they are clearly documented and can thus be analyzed and reviewed by patients. These apps also need to be protected from attacks by hackers.
In addition to this, guidelines on data protection and cyber security can vary from market to market. For instance, there are considerable differences between the EU and the US markets. It is thus imperative to know the laws in the respective market when producing and selling the corresponding medical devices including standalone software. TÜV Rheinland and its subsidiary OpenSky help customers to protect their software and hardware from cyber attacks. This is done through extensive software testing and consulting services aimed at quickly solving any issues.
Medical devices with wireless technologies are a fast-growing market. Wireless devices are user-friendly, can be operated remotely, and increase the efficiency of the healthcare system: doctors can work faster, and synergies can be better harnessed. For devices that monitor inpatients, wireless technology has the advantage of no longer needing to be installed directly next to a bed, thus improving the comfort of the patient. Technologies such as Wi-Fi, Bluetooth, and Zigbee enable devices to be linked in the medical field, which makes data and instructions quicker and easier to transfer.
Just like "analog" medical devices, wireless medical devices are regulated by the Medical Device Directive 93/42/EEC, provided that they are sold in the EU. Medical devices with wireless features are also subject to the new Radio Equipment Directive (RED) 2014/53/EU, which sets standards for all wireless devices marketed in the EU. These standards target the security of wireless devices, e.g. in terms of electromagnetic compatibility (EMC) or voltage. TÜV Rheinland inspects and certifies wireless medical devices for the European market as well as for the non-European market.
Any questions? Would you like an individual, non-binding offer? Then write to us now. We will respond to your request as quickly as possible.