Regulatory challenges in getting medical devices ready for the
Rachael Histed, Associate, DLA Piper.
29 November 2011
The current challenges faced by the healthcare sector are
creating a wealth of opportunity for innovation in the medical devices
With tightening budgets, an aging population and an impending
shortage of healthcare professionals, the healthcare industry is
crying out for improvements in the diagnosis, prevention, treatment
and rehabilitation of illness and disease.
Clinicians and researchers who are inventing and pioneering new
products or services potentially have a lucrative global market at
their feet. Yet the highly regulated and global nature of the
healthcare sector can also lead to extreme challenges as the product
is launched as a business venture, including high costs, lengthy
administration processes and delays in access to market.
The regulatory landscape for medical devices, both in Europe and
globally, is currently under the microscope. While many industry
stakeholders are calling for a more streamlined method of getting
products certified for distribution, the challenge facing industry
regulators is to strike a delicate balance between fostering
innovation and maintaining the highest levels of patient safety.
Within the European Economic Area (EEA), medical devices are
mainly regulated by three European Directives:
- The Medical Devices Directive (MDD)
- The Active Implantable Medical Devices Directive (AIMDD)
- The In Vitro Diagnostic Devices Directive (IVDD)
The Directives were put in place to provide a harmonised
regulatory procedure for all medical devices within the EEA,
implemented in the UK by the Medical Devices Regulations 2002, as
amended. Whilst certain medical devices are exempt, most must carry
a CE mark confirming that a manufacturer is satisfied that the
product conforms with the essential requirements in the relevant
Directives and that it is fit for purpose.
The MDD and IVDD include a classification system whereby the
level of regulatory control to be applied to a medical device is
proportionate to the degree of associated risk. Therefore stricter
controls apply to higher-risk products.
In some cases, a 'Notified Body' (an authorised third party) must
be involved in conformity assessment and if so an identification
number must also be assigned to it by the Commission.
The Competent Authority is the body responsible for implementing
the requirements of the Directives in each Member State. In the UK,
this is the Secretary of State for Health acting through the MHRA.
The Competent Authority is responsible for designating the
Notified Bodies that check that manufacturers of medium and high
risk medical devices have followed the requirements. If the product
is deemed to have conformed with the necessary requirements then it
should have access when exporting to the whole of the Community
market without the need to comply with any national schemes.
Despite developing the harmonised procedure, in recent years, a
number of factors have come into play, including new and emerging
technologies, that highlighted gaps or pointed to potential
loopholes in the current framework. Revisions to both the MDD and
AIMDD were agreed and came into force last year to better strengthen
the regime, improve implementation and maintain public trust and
confidence in the regulatory framework.
Areas addressed included the assessment of clinical data with
manufacturers required to justify the lack of clinical data if none
is made available; the lack of a clinical investigation for high
risk devices if not undertaken; and why post market clinical
follow‑up is not deemed necessary.
A requirement was added that all manufacturers based outside the
EU/EEC must have an authorised representative. Manufacturers became
able to CE mark products dually as medical devices and personal
protective equipment where a cross over exists and medical devices
which are also machinery must now meet any essential requirements of
the relevant machinery directive that may be more specific than
those listed within the MDD.
Access of registration data changed with the following
information no longer being treated as confidential:
- information on the registration of persons responsible for
placing devices on the market according to the Directives;
- information to users sent out by a manufacturer, an
authorised representative or a distributor in relation to a
vigilance procedure; and
- information contained in certificates issued, modified,
supplemented, suspended or withdrawn by Notified Bodies.
Further amendments were also made concerning the
reclassification, sampling and labelling of some medical devices.
Such subsequent modifications to the Directives led to a European
Commission review and public consultation (EC Review) describing the
system as being "too fragmented and difficult to follow" and in need
of further consolidation and simplification.
The EC Review also identified the growing problem of 'borderline
products', where it is unclear whether a product actually falls
within one of the Directives, or whether it should be subject to
another regulatory regime, such as pharmaceuticals, cosmetics or
aesthetic products. Most often, the 'borderline' is between a
medical device and a medicinal product.
In order to decide whether a product is considered a medical
device or a medicinal product, it should be considered whether the
intended purpose of the product taking into account the way the
product is presented (including the claims made); and whether the
method by which the principal intended action is achieved.
For medical devices, the principal intended action is typically
fulfilled by physical means such as mechanical action, physical
barrier, replacement of, or support to, organs or body functions.
For medicinal products the action can usually be achieved by
pharmacological, immunological or metabolic means.
An example of a "borderline product" in the UK, to illustrate the
difficulties faced when seeking to classify products, would be swabs
and wipes intended to be used for a medical purpose eg wound
cleaning. Historically, such products were always regarded as
medicinal products until, in July 2008, the MHRA changed its view
and accepted alcohol-only wipes as medical devices.
In June 2011, Health Ministers of the Member States adopted
Council conclusions on innovation in the medical device sector and
prepared a list of considerations that the Commission is invited to
consider when reviewing the Directives.
Included amongst the issues raised were:
- where necessary, clarification should be made regarding the
definition of medical devices and the criteria for their
- a simple and rapid mechanism must be set up for accelerated
adoption of binding and consistent decisions on the
determination and classification of medical devices in order to
address the growing number of "borderline" cases; and
- the need to consider introducing more harmonised provisions
relating to the content, presentation and comprehensibility of
the instructions for use of medical devices.
The Council conclusions also stressed that in order for
innovation to benefit patients, healthcare professionals, industry
and society innovation should be based on a holistic approach,
inviting the Commission and Member States to take existing measures
into account and when necessary consider further measures which
enhance the capacity for innovation for instance, by considering the
use of innovative funding systems directed, in particular, towards
SME's and those designed to make optimum use of resources from both
the private and public sectors.
Following the EC Review, it is expected that classifications and
exclusions under the Directives will be revised. Indeed, an amended
IVDD is already planned for the beginning of 2012, although
implementation is unlikely to be before 2015.
it is still unclear whether the MDD and AIMDD will be amalgamated
into one Directive, companies that are manufacturing, distributing
or importing medical devices, particularly potential 'borderline
products', will need to ensure that they keep up to speed with
developments concerning the current framework, taking care not to
fall foul of this ever evolving regulatory regime, whilst seeking to
make the most of the opportunities available within the healthcare
industry at this time.
Rachael Histed is an associate in the Litigation
& Regulatory team at DLA Piper, Birmingham.