Regulatory challenges in getting medical devices ready for the market

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 industry.

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.

Regulatory framework

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.

The challenges

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.

Innovation wanted

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 classification;
  • 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.

Future developments

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.


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