Regulation on medical devices in spotlight again
Warning from statutory health insurance about deadline.
RB – 07/2019
The countdown has begun
Starting on 26 May 2020, medical
devices must be placed on the market in accordance with the new EU legislation.
According to the new Regulation, new medical devices may only be approved by
notified bodies that are accredited according to the new requirements of the Medical
Devices Regulation. A single conformity assessment procedure will thus be
implemented throughout Europe, which, in contrast to the previous procedure,
tests new products more rigorously and also monitors manufacturers more
closely. During the legislative process, the German statutory health insurance funds
welcomed these changes made in the interest of patient safety.
German-Irish initiative to extend implementation deadline
The Health Ministers of Germany and
Ireland jointly addressed the Commission at the Health Council meeting on 14
June 2019 in order to obtain an extension of the deadline for implementing the
new Regulation. Hungary and Bulgaria were in favour of this extension, whereas
France considered an extension of the deadline to be a last resort. Many other
Member States, such as Belgium, Cyprus and Lithuania, opposed it. However, the
Member States agreed that the implementation of the new requirements has been
unsatisfactory so far.
The Commissioner for Health, Vytenis
Andriukaitis, did not support the German-Irish initiative. An extension of the
deadline would disadvantage market participants who have made extra effort in
recent months to be prepared in time. He also referred to patient safety, which
will be improved by the new rules.
Statutory health insurance against longer transition period
The German statutory health insurance is
against a longer transition period before the rules of the new Medical Devices
Regulation become applicable. The vast majority of notified bodies, whose task
it is to assess the processes of placing medical devices on the market, have
already applied for designation under the new legislation. The National Association
of Statutory Health Insurance Funds (GKV-Spitzenverband) is of the opinion that
the transition period should now be used by all parties to ensure a smooth
transition from the old legislation to the new Medical Devices Regulation. Industry
associations in particular are called upon to support this process by providing
information to their members. This is in the interest of patient protection and
would strengthen Germany’s position as a location for innovation.
The latest publications of the ‘Implant
Files’ should be incentive enough to quickly implement the new Medical Devices Regulation
and adhere to the timeframe. In addition to the German statutory health
insurance, the European Social Insurance Platform (ESIP), the association of
social insurance institutions in Europe, has also called for the timely
implementation of the new rules in a joint statement.
What happens next?
At the moment, it can be safely assumed
that there will not be a sufficient number of Notified Bodies to meet the new
requirements by 26 May 2020. There are currently two institutions in the EU which
are certified according to the new criteria of the Medical Devices Regulation
and may therefore approve medical devices according to the new quality
criteria. One of these is TÜV SÜD in Munich and the other is BSI in the UK. It is estimated that by the
end of the year a total of 20 notified bodies will be ready to operate under
the new rules. However, this is also seen more as an optimistic assessment.
Certificates issued before 25 May 2020
will remain valid until the date stated in the certificate, albeit no later
than May 2024.
Information from the European
Commission on the status of outstanding and ongoing accreditations would also
contribute to a more objective discussion. The website currently only lists the
above-mentioned accredited bodies (as of 18 July 2019).
Furthermore, it is currently impossible
to obtain an overview of all medical devices available on the European market.
There is also currently no possibility to view data on the safety and efficacy
of individual medical devices at a central location. Under the new Medical
Devices Regulation, EUDAMED is to be introduced as a central
database for medical devices. It will start operations in March 2020 and part
of its content will be publicly accessible.
In the event of a hard Brexit, the
situation will have to be assessed separately. The notified body (BSI) based in
the UK has already put in place a contingency plan for Brexit. The company has
informed manufacturers that it will assist them with migrating their certificates
to their notified body in the Netherlands.
Thus, Brexit per se must not be an
argument to soften the deadlines for compliance with the Medical Devices Regulation.
Based on an analysis of which product groups are affected by Brexit, pragmatic
solutions could be found which take into account the necessary level of safety.
On 25 May 2017, the Regulation on medical devices (2017/745) came into force. The need
to revise the medical devices Directives from the 1990s resulted from scandals involving
the use of defective medical devices. The articles published on the Implant
Files website have again confirmed the shortcomings in the market for medical devices
(See our article from January 2019).
The new medical devices Regulation
addresses the need for action and creates a regulatory framework to improve
patient safety, improve the quality of healthcare and coordinate market access
for innovative medical devices in the EU. The aim is to ensure high-quality,
safe and transparent access to medical devices for patients and service
providers in the EU.