This section provides guidance on the revision of the Medical Devices and Active Implantable Medical Devices (AIMD) Directive which came into force on 21 March 2010.
The current regulatory framework for medical devices has been in operation since 1998. In 2005, a number of regulatory changes were proposed by the European Commission (EC) to strengthen the regime and improve implementation and thus better safeguard public health and maintain public trust and confidence in the regulatory framework. These proposals were negotiated by Member States and, as a result, a revised Directive was agreed in 2007.
The revisions agreed to the Medical Devices Directive and the AIMD Directive were specified in the revision Directive 2007/47/EC (external link).
Consolidated versions of both Directives are available on the EC website:
Council Directive on the approximation of the laws of the Member States relating to active implantable medical devices (external link)
Council Directive 93/42/EEC concerning medical devices (external link)
The changes were transposed into UK law by the Medical Devices Amendment Regulations SI 2008 No 2936 (external link) and are summarised in the evidence base of the impact assessment issued by the MHRA in November 2008.
The Amendment Regulations come into force on 21 March 2010. As Directive 2007/47/EC does not contain provisions for a transition period the Commission has produced relevant guidance on implementation (external link).
In addition, concern has been expressed about devices in the supply chain on the date of the Directive coming into force. The MHRA is of the view that devices are placed on the market at the point they have completed their manufacturing process and are ready to be made available for use.
Some of the revisions simply clarify existing practice and are self-explanatory, however guidance has been put together by the MHRA and the Commission in the following areas for all stakeholders:
- Assessment of clinical data: In order to clarify and enhance the provisions on clinical evaluation, modifications are made to a number of the articles and to relevant annexes concerning clinical data and its evaluation and to various references to clinical data within the provisions of the Directive, including the definition of clinical data and provision for data to be included in the European databank. In summary:
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Manufacturers will have to justify the lack of clinical data if there is none available
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manufacturers will have to justify the lack of a clinical investigation for high risk devices if one has not been undertaken
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if the literature route is followed then there needs to be evidence of equivalency between the manufacturer’s device and that covered in the literature
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where post market clinical follow-up is not deemed necessary, this needs to be justified.
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Updated requirements for clinical investigations can be found in the Clinical trials section.
- Custom-made manufacturers will now be required to review and document experience gained in the post production phase and to set up a post market surveillance system of reporting to authorities, as is already required for other devices. In addition, a requirement is introduced that the 'statement' which accompanies the device should be available to the named patient for whom the device has been manufactured. Guidance on the statement has been drafted by the MHRA in consultation with interested parties. Guidance to Changes to the Medical Devices Directive 93/42/EC with respect to custom-made devices statements
(371Kb).
- Crossover with the Personal Protective Equipment (PPE) Directive. Manufacturers are now able to CE mark products dually as medical devices and personal protective equipment. The EC has produced an guidance on interpretation document on the new provisions (external link). This provides manufacturers with guidance on the conformity assessment process to be followed. Manufacturers should be aware that they should clearly indicate which regulatory regime any such products should come under ie Medical Devices, PPE or both and that it is their stated intended purpose which dictates the conformity assessment to be undertaken. The MHRA will take action to ensure that manufacturers indicate clearly what purpose the product can be used for and do not take advantage of the changes by remaining silent in their claims then carrying on activities that indicate an intended PPE or medical device purpose.
- Machinery Directive: Devices which are also machinery should now also meet any relevant essential requirements of the machinery directive that are more specific than those contained in the Medical Devices Directive. The Commission has produced guidance on these requirements (external link).
- Standalone software: the definition of a medical device has been changed to state that software intended by its manufacturers to be used specifically for diagnostic and or therapeutic purposes are now regarded as medical devices in their own right. Some examples of the types of devices which fall into this category are listed below:
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- The NHS software algorithm to screen for swine flu infection
- software providing a cognitive training/stimulation programme for patients with specific conditions or impairments in order to cause improvements
- a system which detects specific changes in patients using an algorithm acting on data from a number of inputs (eg movements, voice analysis etc) in order to propose clinical interventions, medication, hospital referrals etc
- software facilitating remote large-scale online patient screening, for example to identify ophthalmic conditions diagnosed by qualified hospital ophthalmologists
- software that carries out complex analysis/trending of measured physiological parameters which the clinician rely upon when making a diagnosis.
- Labelling: Special attention should now be paid to any substances (phthalates) which could be carcinogenic, mutagenic or toxic to reproduction used in the manufacture of medical devices. If such devices are intended to administer and/or remove medicines, body fluids or other substances to or from the body or to transport and store such substances, contain phthalates then the devices must be labelled accordingly. In addition to this if such devices intended use includes the treatment of children, pregnant or nursing women, the manufacturer must also provide a justification for the use of these substances within the technical documentation and instructions for use on the residual risk.
- Access of registration data: the revised Directive now states that the following information shall not be treated as confidential:
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- Information on the registration of persons responsible for placing devices on the market in accordance with the Directive
- information to users sent out by a manufacturer, an authorised representative or a distributor in relation to a vigilance procedure
- information contained in certificates issued, modified, supplemented, suspended or withdrawn, by Notified Bodies.
- Sampling regimes for Class 11a and Class 11b Medical Devices. There are now specific requirements for detailed technical reviews by Notified Bodies on a sample of Class 11a and 11b devices during quality assurance assessments.
The links below provide guidance for Notified Bodies on this change:
NBOG Tech File sampling (2009-4) (external link)
Design Dossier (2009-1) (external link)
- Reclassification of some medical devices:
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- The definition of the central circulatory system has been amended to include arcus aorta and aorta descendens which will reclassify some devices to Class III
- under Rule 6 devices in contact with the central nervous system are now Class III
- under Rule 15 devices intended for disinfecting invasive devices are now Class IIb (was IIa)
- under Rule 16 all devices intended for recording X-Ray images are now Class IIa (was non-active only).
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There is now a requirement that all manufacturers based outside the EU/EEC must have an Authorised Representative (AR).
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It has been made clearer that Declarations of Conformity (DoC) must now clearly identify devices specifically by name, code or other reference.
Any further queries on the changes should be directed to:
David Batten
MHRA
5th Floor
151 Buckingham Palace Road
London
SW1W 9SZTel: 020 3080 7254
Email: David.Batten@mhra.gsi.gov.uk
