NEW MEDICAL DEVICE REGULATIONS IN EUROPE
Medical device regulations of Europe is changing. Are you ready for the directive changes?
The following new legislation will be applicable within the EU
26 May 2021: Regulation (EU) 2017/745 on Medical Devices
26 May 2022: Regulation (EU) 2017/746 on In Vitro Diagnostic Medical Devices
Do you want to certify your medical devices according to new regulations?
Medical devices are regulated by specific standards and regulations in Europe.
The following medical devices Directives are changing.
- Directive 98/79/EC of the European Parliament and of the Council on In Vitro Diagnostic Medical Devices (IVDMD)
- Council Directive 93/42/EEC on Medical Devices (MDD)
- Council Directive 90/385/EEC on Active Implantable Medical Devices (AIMDD)
These three directive will be replaced by the following two regulations:
Regulation (EU) 2017/745 on Medical Devices
Regulation (EU) 2017/746 on In Vitro Diagnostic Medical Devices
2017/745 EU MDR will be used instead of 93/42/EEC MDD
On 26 May 2021, 93/42/EEC was replaced by Regulation (EU) 2017/745. New regulation specifies the dates and transition times. Learn more about Medical Device Regulation (EU) 2017/745
2017/746 EU IVDMDR will be used instead of 98/79/EC IVDMD Directive
On 26 May 2022, 98/79/EC will be replaced by Regulation (EU) 2017/746. New regulation specifies the dates and transition times.
Medical devices have to be tested according to Safety and EMC testing standards. Two of well known standards are IEC 60601-1 and IEC 60601-1-2.
Why new regulations?
European Commission of EU published an infographic about the new medical device regulations and they showed why new regulations are published as follows:
1. Increase clinical investigation requirements and manage risk to ensure patient safety
2. Reinforce surveillance and management of the entire MD and IVD life cycle
3. Improve transparency and traceability
4. Reduce ambiguity with clear classifications and definitions
Are you ready to adapt new medical device regulations?
Prepare for new medical device directives. Update your existing certifcations. Design and manufacture your medical devices according to new medical regulations if you are selling to Europe.
Contact us and get your quote for testing and certification services according to new medical devices regulations 2017/745 EU and 2017/746 EU.
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Performance requirements of medical devices are validated with product-specific standards.
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