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On April 5, 2017 the
EU adopted the new Medical Devices Regulation, replacing the two existing
directives, the Medical Devices Directive and the Active Implantable Medical
Devices Directive. The new regulation will enter into force after a three-year
transition period ending in spring 2020. This means that the market access
framework for all member countries of the European single market (28 EU member
states including the UK, the members of the EEA – Iceland, Lichtenstein and
Norway, and through bilateral treaties Switzerland) will change significantly.
The aim of the new regulation
is to address some inherent weaknesses in the old directives as well as the
swift evolution of science and technology in the field of medical devices. To
do so, it introduces a number of key improvements, among them:
ex-ante control for high-risk devices via a new pre-market scrutiny mechanism
with the involvement of a pool of experts at EU level.
reinforcement of the criteria for designation and processes for oversight of
inclusion of certain aesthetic devices which present the same characteristics
and risk profile as analogous medical devices under the scope of these
transparency through the establishment of a comprehensive EU database on
medical devices and of a device traceability system based on Unique Device
introduction of an “implant card” containing information about implanted
medical devices for a patient.
reinforcement of the rules on clinical evidence, including an EU-wide
coordinated procedure for authorisation of multi-centre clinical investigations.
strengthening of post-market surveillance requirements for manufacturers.
coordination mechanisms between EU countries in the fields of vigilance and
5, 2017: The EU Medical Device Regulation was adopted.
2017: The Regulation was published in the Official Journal of the European
May 26, 2017:
The Regulation entered into force and will apply in parallel with the current
medical devices directive MDD 93/42/EEC for a transition period of three years.
2017: The process of re-designating Europe’s Notified Bodies under the new
regulation begins. The first designations are expected to be finalized some 12
to 18 months from the date of publication of the legislation.
2020: The transition period ends and the Medical Devices Regulation becomes
How can manufacturers prepare for the
Considering the amount
of work that needs to be done, the three-year transition period is short.
Manufacturers need to start preparing now to make sure their products are
compliant by May 25, 2020. Here’s how to get started:
your company has a thorough understanding of the new legislation and the
changes from the current Medical Devices Directive.
thorough gap assessments to review your current products against the new
legislation. The gap assessments should also take into account the
reclassification of certain product groups as well as MDR’s wider definition of
a medical device.
mind that the management system standard for medical device manufacturers – ISO
13485 – has also been updated. The final date for transitioning to the new edition
(ISO 13485:2016) is February 28, 2019.
touch with us to discuss the time line for your transition. Intertek intends to
be designated under the new regulation.