SIGNIFICANT CHANGES AHEAD FOR MEDICAL DEVICE MANUFACTURERS
The Medical Device Regulation (MDR) has entered into force on May 26th 2017. The MDR will replace the current EU’s Medical Device Directive (93/42/EEC) and the EU’s Directive on active implantable medical devices (90/385/EEC).
Manufacturers of currently approved medical devices will have a transition time of three years until May 26th 2020 (date of application) to meet the requirements of the MDR. The new MDR provides an additional time after the date of application allowing to place new products under the MDD for max. 4 more years on the market. Additional requirements and limitations will apply for this extended transition period.
- Click here for more information about the new Medical Device Regulation (MDR)
UNDERSTANDING THE MEDICAL DEVICES DIRECTIVE (93/42/EEC)
Directive 93/42/EEC of the European Union (EU) (also known as the Medical Devices Directive - MDD) details the Essential Requirements manufacturers and importers must meet to apply the CE mark and legally market or sell their devices in the EU. Because of the many types of devices covered by the MDD, the specific requirements depend on the classification and intended use of the device. However, in most cases, the use of an EU Notified Body is required to assess compliance with the Directive before the CE mark can be applied to a device.
WHAT ARE MEDICAL DEVICES?
A medical device is any instrument, apparatus or appliance that is used to diagnose, monitor or treat a disease, injury or handicap in humans. The term “medical device” applies to a broad range of products, devices and equipment, from simple tongue depressors and bedpans to laser surgical devices. Medical devices can also include certain electronic radiation emitting devices with medical applications, including ultrasound devices and x-ray machines.
While the term is broadly applied, medical devices should not be confused with other classes of products used to treat medical conditions. For example, medications and pharmaceutical preparations, which treat medical conditions through chemical action or by being metabolised by the body, are not considered medical devices, and are subject to different regulations and requirements.
As part of the Notified Body assessment, a manufacturer must develop technical documentation or design dossiers in order to evaluate the compliance of their device against the essential requirements and establish a quality management system that meets the requirements of the MDD. Manufacturers must also comply with EU Regulation 722/2012 regarding the use of materials of animal origin which requires manufacturers to utilise science-based processes to eliminate or inactivate TSE-infectious agents. In addition to legislative documents, manufacturers must also consider guidance documents, consensus statements and interpretative documents under the MDD.
WHY CHOOSE TÜV SÜD
By complying with the Essential Requirements of the EU’s MDD and other regulations that apply to medical devices, manufacturers can tap into the European marketplace which consists of 500 million consumers. In addition, medical devices bearing the CE mark may achieve faster regulatory review and approval in other global markets. TÜV SÜD Product Service is the world’s largest EU Notified Body for medical devices covered by MDDs. Our extensive network makes TÜV SÜD Product Service an effective single source for manufacturers seeking expertise in the testing and certification of medical devices to EU requirements, as well as regulations applicable to these devices in other major medical device markets.
OUR SERVICES AT A GLANCE
- Design dossier and technical documentation review - TÜV SÜD Malaysia reviews all documentation for the device according to the requirements of the MDD as set out in the Directive’s Annexes.
- Quality system auditing - TÜV SÜD performs a quality management system audit consistent with the requirements of Directive.
- Testing services - TÜV SÜD Malaysia can provide compliance testing for medical devices in accordance with various relevant regulations and standards