Support for Medical Device Submissions
- CE Technical File according to MDR requirements
- FDA, EFS and 510(k) Submissions
- CFDA, China
- TGA, Australia
- Health Canada
The main reason behind this change
Problems with diverging interpretation of the current Directives as well as some incidents with breast implants and metal hips highlighted the weaknesses of the current legal system and damaged the confidence of patients, consumers and healthcare professionals in the safety of medical devices. Such problems should not occur again and the safety of medical devices available in the EU has to be strengthened. Moreover, revision of the legislation was necessary to consolidate the role of the EU as a global leader in the sector over long-term and to take into account all technological and scientific developments in the sector.
The new regulation will ensure
- a consistently high level of health and safety protection for EU citizens using products.
- the free and fair trade of products throughout the EU
- that EU legislation is adapted to the significant technological and scientific progress occurring in this sector over the last 20 years.
The new regulation contains a series of extremely important improvements to modernize the current system. Among them are:
- stricter control for high-risk devices, a new pre-market scrutiny mechanism with involvement of a pool of experts at the EU level;
- the reinforcement of the criteria for designation and processes for oversight of Notified Bodies.
- the inclusion of certain aesthetic devices which present the same characteristics and risk profile an analogous medical devices under the scope of these Regulation;
- improvement transparency through the establishment of a comprehensive EU database on medical devices and of a device traceability system based on Unique Device Identification (UDI)
- the reinforcement of the rules on clinical evidence including an EU-wide coordinated procedure for authorization of multi-center clinical investigations.
- the strengthen of post market surveillance, requirements for manufacturers.
- improvement coordination mechanism between EU countries in the fields of vigilance and market surveillance
The Regulation on Medical Devices (MDR) went to in effect in May of 2017, effectively
replacing decades-old legislation and creating new quality and transparency
requirements for medical device companies in the European Union,
The official Journal of the European Union published the MDR. The new rules replace
Medical Device Directive (93/42) and the active implantable Medical Devic Directive
Although the MDR technically "in effect" there will be a transitional periof of up to five
years for companies to fully comply with the directives. Due to the Corona Virus the
MDR has been postponed and will be mandatory from May 2021.
The new requlations outline stricter quality requirements as well as enhanced
transparency for medical device manufacturer or imported to the EU. The new
regualtions represent and oppertunity for medica device manufacturers and sellers
to tap in to a million-dollar market while also increasing the chances of positive
Quality System updates
The MDR outlines new quality and risk management obligations for medical device
companies. Specifically, the new regulation lays out more specific guidelines for the
production and quality procedures associated with devices.
The MDR requires that company create a documented risk management plan for
meidical devices that identifies possible risk associated with the device's use, and
thoroughly evaluates the information gained from a device's production phase to
identify possible hazards.
On top of updates to quality and risk management systems, medical device
manufacturers must also create a post market surveillance plan. These regulation will
be checked randomly by inspectors.
Classification Changes for Medical Devices
The MDR brings slight changes to the classification of medical devices. Medical devices are
currently classified as either Class I, Class IIa, Class IIb or Class III. The higher the class level, the
MDR will move certain devices that come in contact with the spinal cord in Class III. In addition,
certain changes have been made to some apps for medical devices used on smartphones.
As result of these changes, medical device manufacturers will neee to make sure they are
compliant with the new classification rules.
In a attempt to make medical device information more accessible, MDR will make certain
information regardin medica devices accessible to the public through the European Database on
Medical Deives, or "Eudamed"
The Eudamed database will include information on devices, market surveillance, clinical
investigation information, and safety and clinical performance.
Medical devices in the EU will also be tracked online with a Unique Device Identification (UDI)
number, making to glean information on individual products. These UDI number will be located
Increasing Safety and Transparency with MDR
The goal of these new requlations is to improve safety, quality and transparency for medical
devices across the EU. Regulations for the MDR will no become applicable right away. There is a
transition period of three years for the MDR.
All medical device manufacturers and distributors (economic operators) will hae to abide by the
new regualtions. No company will be "grandfathered" in.