POSITION PAPER
16 March 2016
Draft Position Paper on MDD Recast
1
DRAFT POSITION ON MDD RECAST
Eucomed recognises the need to strengthen the current medical devices legislation in Europe (Directives 93/42/EEC;
90/385/EEC; 98/79/EC - MDD), in particular by introducing more European coordination and management of the
regulatory system, in order to achieve a smart and efficient legislative framework that is consistently implemented across
the EU and will continue to guarantee high quality, patient safety and fast access to the latest medical technologies while
encouraging research and value-based innovation and reducing administrative burden. Key areas for better coordination
and management are the notified bodies and vigilance system.
Alternative text
Eucomed recognises the need to strengthen the current medical devices legislation in Europe (Directives
93/42/EEC; 90/385/EEC; 98/79/EC - MDD) in particular by introducing more European coordination and
management of the regulatory system. The objective should be to achieve a smart and efficient legislative
framework that is consistently implemented across the EU and will continue to guarantee high quality, patient
safety and fast access to the latest medical technologies. It should at the same time encourage research and
value-based innovation and reduce administrative burden. Key areas for better coordination and management
are the notified bodies and vigilance systems.
The current European system for market access and management of medical devices allows for the quickest patient
access to medical devices in the world while at the same time ensuring a high level of quality and safety for patients and
healthcare professionals.1 Eucomed agrees with the European Commission that the existing legal framework needs
revision, one of the reasons being that the current system is too fragmented and lacks consistent implementation and
cross-border coordination. Multiple forms of national registration processes, different levels of notified body performance
and oversight as well as differing national safeguard measures and approaches to vigilance, borderline and
classification, create a plethora of varying requirements across Europe. In addition to the unnecessary time and cost
spent, which can be detrimental to SMEs operating in the market, the fragmentation causes differing levels of safety
across the EU which is obviously unacceptable. Moreover, the system’s complexity and lack of transparency and
predictability must be addressed in order to build trust among patients, consumers and healthcare professionals as well
as industry.
Given the challenges facing European health systems in terms of demand driven by a rapidly ageing population and
emerging shortages of carers, it is clear that rapid innovation in the way that health systems are structured and managed
will be a prerequisite for providing sustainable, high quality healthcare for Europe's citizens in the future. Innovative
medical devices and services are part of the solution to public health challenges as well as the broader challenges to
1
The current system allows the quickest possible access for patients to innovative medical technologies – two years faster than in
the United States and five years faster than in Japan” (BCG: “EU Medical Device Approval Safety Assessment - comparative
analysis of medical device recalls 2005-2009”, January 2011,
http://www.eucomed.org/uploads/Press%20Releases/BCG%20study%20report.pdf accessed 8/9/2011; John Makeover: “FDA
Impact on US Medical Technology Innovation”, November 2010,
2
Europe’s competitiveness. The Medical technology (MedTech) sector consists of a large and highly skilled workforce 2
that contributes significantly to keeping the European population healthy and productive while contributing to the
European knowledge-based economy.
Eucomed believes that the MedTech sector’s ability to continue the delivery of safe and efficient life-enhancing medical
care for patients and consumers is based on the strength and immense innovative capacity of our sector, which is, in
turn, dependant on Europe having an appropriate and ‘smart’ legal framework.
Any new legislative framework must support and enhance the capacity for value-based innovation in the European
MedTech sector, especially SMEs. The ability to innovate is key to keeping the sector competitive - and a prospering
medical devices sector helps Europe prosper. Europe needs ‘Smart’ regulation that makes efficient and effective use of
existing resources (competent authorities, notified bodies and industry) so as to retain a simple, flexible and highly
efficient system that supports the specific functioning of the MedTech sector.
With this background, we outline below our proposals for improving the Medical Devices Directives so as to maintain the
high level of safety and quality of and access to needed medical devices, while ensuring that legislation and procedures
are simple, smart and efficient and thus fostering European innovation and competitiveness.
I.
A European approach: Better coordination and management
The medical device oversight is highly decentralized, with significant reliance on Member State appointed and accredited
notified bodies and frequent inspection of manufacturers. With over 22,000 businesses, 80% of which are SMEs, and
half a million individual products, the large number of notified bodies makes it possible to process many applications and
businesses simultaneously, thus avoiding bottlenecks and allowing appropriate costs and timings as well as maintaining
a high degree of innovation. All of this ultimately benefits patients, healthcare professionals and carers. Eucomed
believes that decentralisation, which is the essence of the current system, should remain a basic principle in order to
preserve the current safety, flexibility and pace.
However, the upcoming recast should strengthen the European approach which is based on two pillars, the Member
States and the European Commission who currently ???, through increased collaboration between member states and
with the European Commission, in order to effectively address current disparities across Europe and thus further
galvanize patient safety while maintaining a European regulatory environment that truly fosters innovation.
Increased coordination and management is needed especially in the following areas:


Training / auditing / education of Notified Bodies
Establishment of a database for central registration, vigilance reports and clinical information
2
There are almost 22,500 medical technology companies in Europe; of these nearly 18,000 – around 80% - are small to mediumsized or even micro –enterprises (Eucomed data)
3





Enhancing transparency including enforcement decisions, Notified Body performance, and elements of the
database
Development of harmonised standards and guidelines
Management of decision processes for classification, borderline, etc.
Management of working groups
Horizon scanning of technologies and potential health concerns related to medical technologies
It is Eucomed’s position that central management should ideally be coordinated with administrative support by the Joint
Research Centre (JRC). The JRC is ideally placed to support the system due to its:




European-mindedness and capability of driving a coherent EU policy approach;
Focus on research, innovation, technology, engineering, bioengineering and materials science which are all basic
components of the MedTech sector;
Alignment with the Europe 2020 initiative, in particular with the EU Innovation Partnerships on Active and Healthy
Aging;
Relatively low cost of service.
BOX: Enhanced coordination and management would lead to
binding decisions on a proper legal basis;
1. Sufficient human and financial resources from Member States
and EC;
2. Transparent
and
consistent
decision-making
and
implementation;
3. Appropriate stakeholder involvement;
4. A clear commitment of policy makers to foster innovation.
In addition to ensuring better coordination and management of the system overall, the recast must also address the
specific disparities in requirements, standards and decision-making, e.g. by introducing effective and harmonized
guidelines for approval, including data requirements, as well as a coordinated approach to vigilance and post-market
surveillance.
II.
Notified Bodies
While many notified bodies is a good thing, due to lack of transparency and voluntary rather than mandatory standards it
cannot be guaranteed that we have the same high quality of notified bodies across Europe. The measures needed are
more coordinated control of notified bodies by competent authorities, operating in coordinated teams, based on clear and
precise regulatory requirements for designation and monitoring, including competence, transparency, EU-wide
accreditation standards and coordinated training/monitoring of notified bodies. In addition, Eucomed calls for the
European Commission to provide central oversight of the way member states designate and monitor their notified bodies
to guarantee a high level of quality and consistency across Europe. This should include participation together with the
competent authority teams carrying out designation and monitoring activities..
III.
One approach to vigilance and post-market surveillance
4
Likewise, a better defined legal framework on vigilance and greater harmonisation of member states’ post-market
surveillance activities are needed to ensure that problems experienced with specific devices are properly and efficiently
reported, investigated and reacted to in a consistent manner across relevant member states. Ideally, adverse events
should be reported to one EU portal and analysed by Member States and the Commission using sound, independent
scientific policy advice from the JRC, allowing for a rapid EU-wide response, thus benefitting overall patient safety. One
of the tools supporting European-wide post-market surveillance could be the EUDAMED database, if improved for this
purpose e.g. for central reporting.
IV.
Harmonized standards
While Eucomed believes that EU standards should prevail as a core vehicle to ensure the safety and performance of
medical devices, disparities in the level of participation of European authorities in the development of safety standards
has fallen behind that of other global regulatory and trade partners such as the USA. This has led to emerging doubts
about the adequacy of European standards across the EU member states. This lack of implementation must be
addressed. With this objective, the Commission’s processes and procedures for mandating and harmonising medical
device standards must incentivise the reengagement of European competent authorities’ experts into the development
and harmonisation process with a view to ensuring an improved and higher quality of European harmonised standards.
V.
Harmonized Guidelines
Today, in consultation with Member States and affected stakeholders, the Commission issues medical device guidelines
on appropriate implementation and interpretation of the MDD to help support a harmonised high level of safety and
improved functioning of the internal market. In reality, many Member States do not oblige themselves, notified bodies or
manufacturers to follow these guidelines. In addition the guideline development process lacks pace and legal certainty.
The establishment of a revised guideline development process that leads to a ‘de facto’ or ‘de jure’ application of those
guidelines would help address what is, at this stage, a severe disparity across EU member states in terms of
implementation of the MDD. Moreover, an efficient mechanism supporting member state coordination could help address
key areas such as good design control, risk management plans, emerging technologies, post market clinical follow-up,
vigilance, clinical evidence, labelling and borderline and classification.
VI.
Transparency
The recast must result in greater overall transparency and access to information for patients, consumers, healthcare
professionals and manufacturers as well as for notified bodies and authorities. Increased use of ICT and in particular a
single EU database, partly available to the public, would provide a much needed solution. The database could include
information such as devices on the market (UDI/device information), registration of economic operators, vigilance, market
surveillance, clinical investigation, notified body and enforcement, CE certificates, declarations of conformity and labels
and manuals. Mindful of costs and Member States’ ability to structure and access information they need this EU
database could tendered out and sub-contracted via a Governing Committee of Member States who take ownership. A
Management Committee of Member States, DG SANCO, JRC and Industry would then oversee the functioning, including
5
any registration fees. This EU database would also eliminate unnecessary administrative burden and duplication as it
would replace any and all national databases.
Eucomed
Eucomed is the voice of the medical technology industry in Europe Eucomed represents directly and indirectly 4,500
designers, manufacturers and suppliers of medical technology used in the diagnosis, prevention, treatment and
amelioration of disease and disability. The mission of Eucomed is to improve patient and clinician access to modern,
innovative and reliable medical technology.
More information is available on www.eucomed.org or contact:
Place des Maïeurs 2
1150 Brussels
Tel: +32 (0)2 772 22 12
Fax: +32 (0)2 771 39 09
6