Medical devices in Europe are regulated under the European Medical Device Regulations (EU 2017/745) which have applied since May 2021. Manufacturers must comply with the Regulation when placing new medical devices on the market. The EU MDR repealed Directive 93/42/EEC on medical devices and the Directive 90/385/EEC on active implantable medical devices and changed the European legal framework for medical devices, introducing new responsibilities for national competent authorities in the assessment of certain categories of medical device. Prior to placing a device on the market in the EU, a manufacturer is required to ensure it meets the requirements of the Regulation’s Unique Identification rules, and is included on the UDI database. If located outside of the EU, a manufacturer will need to engage the services of an Authorised Representative with physical presence in the EU, who will take care of regulatory issues on the ground in the EU. Other Regulations exist for other categories, such as:
- In Vitro Diagnostic Medical Devices, covered by EU 2017/746
- Cosmetics, covered by EU 1223/2009
- Medicinal Products, covered by Directive 2001/83/EC (or by 1394/2007 for advanced therapies)
The EU Medical Devices Regulations (EU MDR) EU 2017/745
The EU MDR has a very wide scope and is much more stringent in its requirements than the previous Directives that it replaces. It remains important to realize that the intended purpose and claims made in the marketing of a device can cause it to be covered or excluded. The scope includes equipment intended by the manufacturer to be used to diagnose, prevent, monitor, treat, alleviate, compensate for and/or control a disease, injury, handicap, physiological process or conception. The Directive excludes any products which come within the scope of the EU IVDR, but incorporates active implantable devices which were previously regulated separately to other medical devices.
The Medical Devices Regulations (MDR) provides a harmonised regulatory environment for all medical devices sold within Europe. All products which fall within the scope of the Regulations must meet certain essential safety and administrative requirements and are to be CE marked to show that they comply. Such products may then be freely sold throughout Europe without additional regulatory constraints.
The MDR defines a medical device as:
“any instrument, apparatus, appliance, software, implant, reagent, material or other article intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the following specific medical purposes:
- diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of disease,
- diagnosis, monitoring, treatment, alleviation of, or compensation for, an injury or disability,
- investigation, replacement or modification of the anatomy or of a physiological or pathological process or state,
- providing information by means of in vitro examination of specimens derived from the human body, including organ, blood and tissue donations, and which does not achieve its principal intended action by pharmacological, immunological or metabolic means, in or on the human body, but which may be assisted in its function by such means.
The following products are also deemed to be medical devices:
- devices for the control or support of conception;
- products specifically intended for the cleaning, disinfection or sterilisation of devices.
and the regulations include coverage of devices intended to administer a medicinal product or which incorporate as an integral part a substance which, if used separately, would be a medicinal product.
Devices for Special Purposes
Article 21 of the EU MDR covers special requirements for custom-made devices, those intended exclusively for the purposes of clinical investigation and for presentation or demonstration devices. These three categories of product are excluded from certain of the Regulation’s provisions, though others will still apply.
Excluded from the provisions of the EU MDR are:
- in vitro diagnostic medical devices which fall within the scope of the EU IVDR (2017/746)
- in vitro diagnostic component parts of medical devices, where the overall device may be covered by the EU MDR (2017/745), but the in vitro part remains covered by EU IVDR (2017/746)
Medicinal products, advanced therapy medicinal products, cosmetics, human blood products, transplant tissue of human or animal origin and food are also excluded, but covered by other Directives.
Due to the wide scope of the MDR, there is potential overlap with other Directives. However, the MDR includes provisions for all relevant hazards through Harmonised standards referenced in the Official Journal of the European Union - including mechanical and electrical safety and provisions for electromagnetic compatibility. Devices which fall within the scope of the MDR are generally excluded from the scope of the other Directives and regulations. However, equipment that may have an application which is not exclusively medical will usually have to comply with the other Regulations and Directives in addition to the MDR.
It is also important to realise that some equipment may fall into or out of the scope of the MDR solely on the basis of the purpose to which the equipment is intended to be put and the way it is marketed. If the manufacturer makes any claims that the equipment provides information pertaining to the definition of a medical device in Article 2 of the MDR, then the regulations will apply.
There are, of course, devices that fall between the descriptions available in the EU MDR and these are know as borderline devices. Separate Guidance is issued by the EU on the classification of these devices as Medical Devices or not.
The EU MDR applies different administrative requirements to devices depending on the risk which they present to the user. There are four classifications:
- Class I - generally regarded as low risk
- Class IIa - generally regarded as medium risk
- Class IIb - generally regarded as medium risk
- Class III - generally regarded as high risk
The device classification is determined by a series of 22 rules which are laid out in Annex VIII to the MDR. Essentially these start by saying that anything which is not covered by one of the other rules is a class I device, and then go on to give more detailed rules for the classification of other equipment. Typical factors upon which the rules decide are whether the device is intended for long term or short-term use, whether it involves the use of associated pharmaceuticals and chemicals, whether it is invasive in normal bodily orifices or via surgical insertion, and whether it operates by the exchange of energy with the body. Definitions of terms used to describe these factors are also included in the Annex.
Caution: This is not an exhaustive list of the factors covered in the rules; these rules are complex and should be considered carefully in the light of each specific application.
Registration of Devices
All medical devices require registration with the EU through their centralised UDI database, and information for this is provided in Articles 29, 31 and 32 of the MDR.
Annex I of the MDR details a series of General Safety and Performance requirements for the design of medical devices. These requirements apply to all medical devices and include, for example:
- a general requirement for safe design
- the minimisation of risks from contamination
- compatibility with materials with which they are likely to come into contact
- the minimisation of hazards of infection and microbial contamination
- provision of sufficient accuracy (for devices with a measuring function)
- protection against radiation
- adequate product marking
- adequate user instructions
The details of these requirements are laid out in a series of standards which have been (or are being) developed to meet the requirements of the Regulation. If these standards are harmonised through publication in the Official Journal (OJ) of the European Union, then compliance with the standard gives a presumption of conformity to the relevant part of the MDR.
In addition to Registration, manufacturers (or their agents) must typically:
- comply with the essential requirements of Annex 1 of the Directive
- demonstrate design verification
- carry out a risk assessment
- demonstrate clinical evidence of the effectiveness of the device
- implement a procedure for post market surveillance
- complete a Declaration of Conformity
- maintain a file of technical information about the product
- Put the CE mark on the product (or its packaging)
The different classifications of medical device are subject to different conformity regimes, as follows:
- CLASS I devices are subject only to the requirements laid out above, (except for sterile products and measuring devices which are also subjected to a limited degree of notified body intervention relating to those aspects of the device affecting the sterility or the measuring function. Intervention is likely to consist of a type approval and the audit of a quality systems and manufacturing processes.)
- CLASS IIA devices are subject to all the requirements for Class I devices, and additionally the manufacturer is required to undergo an audit of their production quality assurance scheme by a notified body. This does not necessarily require a fully integrated ISO 13485 Quality Management System (QMS) but without this, a type approval of the product would be required instead.
- CLASS IIb devices are subject to all the requirements for Class I devices, and in addition the manufacturer is required to maintain a full quality assurance system covering all aspects of production from design through to final examination and testing. For practical purposes this means compliance with EN ISO 13485. In most cases, type approval of the product by a notified body is an integral part of the quality system registration.
- CLASS III devices are subject to the same requirements as Class IIb devices but additionally the manufacturer must submit a design dossier to a notified body for approval.
Post-Market Surveillance and Vigilance
One of the other provisions which distinguishes the Medical Device Directives from the other New Approach Directives is that they establish standing committees to consider the development and application of standards produced in support of the essential requirements, and to consider (in effect) 'matters arising' regarding the safety of devices within the scope of the Directives.
As part of this process of consideration, the requirement for a formal vigilance procedure is established by the Directive, through which manufacturers, their Authorised Representatives, health professionals and others must have a plan for obtaining information on the performance of devices in the marketplace and report certain problems which arise in the use of medical devices and in clinical trials. This vigilance system is administered by the MHRA in the UK, and requires each manufacturer to have a procedure in place for post market surveillance and reporting of adverse incidents.
As with all CE marking directives, the actual requirements for any piece of equipment under the directive are complex and dependent on not only the design but also the type of user, the intended use and sometimes even what is claimed in the instructions or sales literature.
For further advice specific to your products, please contact us at Conformance and we will be pleased to discuss your needs.