MDR Medical Devices Regulation
Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC (Text with EEA relevance) https://eur-lex.europa.eu/eli/reg/2017/745/oj
IVR In Vitro Diagnostic Medical Devices Regulation
Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU (Text with EEA relevance) https://eur-lex.europa.eu/eli/reg/2017/746/oj
Why do medical devices need cybersecurity?
As medical devices get smarter features providing more efficient and easy-to-use solutions to patients the used technologies can introduce additional risks for patient health and their personal data. These smart features are usually implemented with software, internet connection and other IT technologies.
These technologies introduce cybersecurity risks in the medical device and based on the device’s features, functionality and the data it handles it can become a target for cybercriminals. Health data is considered sensitive personal information therefore in case of a cyberattack where the attackers steal patient data or harm patient safety the manufacturer/developer of the device can face serious fines.
What are the current cybersecurity regulations on medical devices in the EU?
EU regulations on medical devices have been adopted and entered into force on 25 May 2017.
These are:
MDR 745/2017 - MDR Medical Devices Regulation; EU 2017/745IVDR 746/2017
IVDR In Vitro Diagnostic Medical Devices Regulation; EU 2017/746.
How can manufacturers ensure medical device. security compliance?
Both regulations (MDR and IVDR) contain cybersecurity requirements. The goal of the policy makers was to create a regulation that ensures an industry standard security level without burdening market entities too much. The result is a risk-based approach where manufacturers/developers identify, analyze, and manage cybersecurity risks relevant to their product and create the necessary procedures and documentation to handle cybersecurity risks.
How can QIMA support medical device manufacturer companies in compliance to the latest regulations?
We offer “zero to hero” and integration services which help manufacturers/developers to achieve cybersecurity MDR compliance.
Our comprehensive services help from product design through development and MDR/IVDR certification. . They provide a clear path to compliance through methodology based on internationally recognized standards.
Integration services build on customers’ already implemented management systems that comply with relevant industry standards. Integration services help customers to utilize their already implemented processes instead of creating new ones.
What is the purpose of the usage of standards?
Compliance to internationally recognized standards eliminates quality discrepancies. A manufacturer/developer might think that a freshly designed and planned cybersecurity activity will be compliant to regulatory requirements but during the certification process the notified body might reject the evidence because of insufficient quality. Standards are created by a group of experts on the relevant field and contain every pertinent aspect of the topic. Compliance to internationally recognized standards ensures that designed and implemented security procedures are secure. It creates a common language between the manufacturer/developer and the notified body.
How long does a medical device evaluation period take?
As each project and product evaluation is different, there is no exact answer to this question. It depends on many factors such as product complexity and assurance claims. The certification time also depends on the selected certification body. Contact us and we will help you put together a project plan and schedule.