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Regulation impact statement: Changes to premarket assessment requirements for medical devices

26 June 2013

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Attachment C: Proposed changes to European Union Medical Devices Directive

On 26 September 2012, the European Union (EU) Commission released a package of proposed reforms of medical device and in vitro diagnostic (IVD) medical device regulation in Europe.

The EU is proposing updated regulations on medical devices to ensure these products are safe, and can be freely and fairly traded throughout the EU. This involves consolidating the three existing directives on medical devices, Active Implantable Medical Devices (AIMD) and IVDs, into two new directives with three overall objectives:

  • to ensure a high level of protection of human health and safety;
  • to ensure the smooth functioning of the internal market; and
  • to provide a regulatory framework which is supportive for innovation and the competitiveness of the European medical device industry.

Underpinning these broad objectives are a series of specific objectives:

  • Uniform control of notified bodies: ensuring the legal requirements concerning the premarket evaluation applied and implemented effectively in all member states in a consistent and efficient way, with:
    • notified bodies designated only for the assessment of devices or technologies which correspond to their proven expertise and competence
    • the position of notified bodies vis-à-vis manufacturers is strengthened with all notified bodies following the same high standards and criteria when they assess the conformity of medical devices.
  • Enhanced legal clarity and coordination in the field of postmarket safety: ensuring complete information regarding safety issues and enhancing coordination of competent authorities regarding incidents and non-compliant products. The aim is to avoid duplication of work and inconsistent reactions to the same problem in different Member States.
  • Cross sectoral solution of "borderline" cases: the relevant legislations need to be clearly delimited from each other. Moreover, experts from different regulatory fields may need to discuss the question together. The aim is to set up a mechanism involving other relevant regulatory authorities (pharmaceuticals, biocides, food, cosmetics etc.) which would allow for the EU-wide determination as to which legislation is applicable to a given product or type of product.
  • Enhanced transparency regarding medical devices on the EU market, including their traceability: enhance transparency by developing modern IT tools building on the Eudamed databank, allowing better tracking and tracing of certain devices in the interest of patient safety. Better traceability would help to contact users of devices when these devices need to be modified or taken off the market and to identify counterfeit devices.
  • Enhanced involvement of external scientific and clinical expertise: provide for access at EU level to scientific and clinical expert advice to support decision-making, taking into account "real use" experience with devices and the needs of patients and users.
  • Clear obligations and responsibilities of economic operators, including in the fields of diagnostic services and internet sales: provide a clear and simple description of the obligations and responsibilities of the relevant economic operators (manufacturers, authorised representatives, importers, distributors) to make it easier for them to comply with the requirements and for competent authorities to enforce them, so ensuring that only safe products are placed on the EU market or put into service. Clarification should be provided that devices used in the framework of commercial diagnostic services provided to the EU market fall within the scope of the legislation on medical devices. Addressing the issue of internet sales will enhance the safety of devices offered via the internet and contribute to the fight against counterfeit products.
  • Governance - efficient and effective management of the regulatory system: well structured and result-oriented coordination between the national competent authorities and the Commission to ensure a high level of patient safety and the good functioning of the internal market, sharing of resources and avoid duplication of action. Tasks to be fulfilled at EU level include organisation of expert group meetings, document management, development and maintenance of IT tools, pooling of experts, and a central contact point for authorities and stakeholders, in particular manufacturers.

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These reforms were prompted by a number of concerns.

  • Oversight of notified bodies: The primary task of notified bodies is to carry out an assessment of the manufacturer's quality management system and/or the design of a device before those medical devices which require a third party certification are placed on the market. Currently there are 78 notified bodies are designated by 24 EU member states.

    Currently there are reportedly variations in the:

    • designation and monitoring of the notified bodies by member states, such as the level of oversight authorities provide to ensure notified bodies are designated only for the assessment of devices or technologies which correspond to their proven expertise and competence
    • quality and depth of the conformity assessment performed by notified bodies, in particular in relation to the assessment of the manufacturers' clinical evaluation or the use of their existing powers such as unannounced factory inspections or product checks.

    These differences can lead to varying levels of protection of patients' and users' safety which, from a public health perspective, is an issue of concern. In addition, it distorts competition between manufacturers of similar products.

    Changes included in the reforms to address this include:

    • Member states to more closely monitor activities of notified bodies, based on the following criteria for clinical evaluation and clinical investigations:
      • clinical evaluation needs to demonstrate safety and performance of the device
      • Process for conducting clinical investigations is further developed- with introduction of the "sponsor" term which applies to the manufacturer, his authorised representative or another organisation conducting clinical investigations for the manufacturer
      • Every clinical investigation must be registered in a publically accessible system which the Commission will establish
      • Before clinical investigations commence, sponsors must submit an application to confirm there are no health and safety, or ethical aspects would oppose it, allowing health and safety aspects of a device to be assessed by member states
    • Notified bodies (for both newly designated and regular interval monitoring of existing) will subject to joint assessments with experts from other member states and the EU Commission
    • Notified bodies to carry out unannounced factory inspections of manufacturers and conduct physical and laboratory tests on devices
    • Notified body personnel involved in assessment of medical devices will be required to rotate at intervals to ensure a balance between knowledge and experience to carry out thorough device assessments and for continuous objectivity and neutrality in relation to the manufacturer subject to those assessments
    • Manufacturers must have a "qualified person" responsible for regulatory compliance
    • The notified body audit of manufacturers quality management system, technical documentation check and examination of the design dossier have been streamlined and tightened by specifying rules according to which notified bodies perform assessments (i.e. documentation to be submitted, scope of the audit, unannounced factory inspections, sample checks). This ensures a level playing field and avoids notified bodies being overly lenient.
  • Postmarket safety (vigilance and market surveillance): Member states collect and analyse information about serious incidents occurring with devices and restrict or ban the marketing of a device when it may compromise the health and safety of a patient, user or third person or when the CE marking has been illegally affixed to a product.

    Member states assess incidents and inform each other about measures taken or contemplated in order to minimise the recurrence of such incidents, however the number of reports exchanged vary significantly between Member States. The criteria for reporting are applied diffidently in different member states, and there are no consolidated statistics regarding the total number of incidents reported.

    The national competent authorities also appear to react in different ways to the same problems, so that while some member may ban or restrict a device, it may freely circulate in other member states. This puts into question a harmonised level of protection of patients and users in the EU and also creates obstacles to the internal market.

    Changes included in the reforms to address this include:

    • Introduction of an EU portal where manufacturers must report serious incidents and corrective actions taken to reduce the risk of reoccurrence. The incidents and corrective actions are then automatically forwarded to the national authorities concerned
    • Where same or similar incidents have occurred, or where corrective action has to be taken in more than one member state, a coordinating authority will take the direction of coordinating the analysis of the case to reduce work and expertise sharing to avoid procedure duplication
    • Reinforce rights and obligations of the national competent authorities to ensure effective coordination of their market surveillance activities and to clarify applicable procedures.
  • Regulatory status of products: The demarcation between the medical devices directives and the other regulatory frameworks applicable to e.g. medicinal products, biocides, food or cosmetics is not always clear. In the case of food and medical devices, the respective legislations are even overlapping. Since a decision on the regulatory status of a product falls within the competence of member states, divergent interpretations in respect to "borderline" cases lead to the application of different legal regimes in the various member states and lengthy discussions between authorities. "Borderline" cases also exist between medical devices and IVD which need to be decided since the existing directives for these devices are mutually exclusive.

    Borderline and classification problems can be circulated among the member states through the so-called 'Helsinki procedure' to reach consensus amongst the competent authorities. However controversial cases can remain unresolved, and consensus statements are not legally binding and competent authorities or national courts may decide at any moment not to follow them.

    The application of different regulatory regimes to the same product compromises both the protection of patient safety and the internal market, reducing the legal certainty and prompts criticism from stakeholders. The lack of uniform qualification (or classification) of a product across the EU creates a fragmentation of the internal market (as a manufacturer must follow different legal regimes in order to sell the same product in different Member States) and may put patient safety at risk.

    Changes included in the reforms to address this include:

    • Extension of the proposed Directive to:
      • Products manufactured using non viable human tissues or cells, or their derivatives that have undergone substantial manipulation, unless covered by Regulation (EC) No 1394/2007 on advanced therapy medicinal products
      • Certain implantable or other invasive products without a medical purpose and that are similar to medical devices in terms of characteristics and risk profile (e.g. non corrective contact lenses, implants for aesthetic purpose)
      • Extension of the definitions section of the Regulations, aligning definitions in the field of medical devices with established EU and international practice such as the new legislative framework for the marketing of products and guidance documents produced by the Global Harmonization Task Force (GHTF) for medical devices
    • Products not covered by the proposed Directive include:
      • Products that contain or consist of viable biological substances (e.g. living microorganisms)
      • Food covered by Regulation (EC) No 178/2002 (e.g. certain slimming products)
    • For borderline medicine/medical device products, if the product is defined as a medical device, it was be classified by the highest risk class for medical devices
    • The Commission may set up a group of experts from various sectors (such as medical devices, IVDs, medicinal products, human tissues and cells, cosmetics and biocides) to determine regulatory status of borderline products
    • Sponsors to submit evidence such as EU declaration of conformity or certificate issued by an EU notified body that the medicine/medical device boundary product device complies with the general safety and performance requirements of the future regulations on medical devices
    • Regulation EC No 1223/2009 to be amended to empower the Commission to determine whether or not a product falls within the definition of a cosmetic product
    • Regulation 528/2012 to be amended concerning making available on the market and use of biocidal products
    • Food regulation (EC) No 178/2002 to be amended to exclude medical devices from its scope
    • The proposed regulations will facilitate the adoption of EU wide decisions on borderline cases where the regulatory status of product needs to be clarified.
  • Lack of transparency: No exact data exist as regards the number, the types and the approval status of medical devices on the European market. The European associations representing the medical technology industry give an estimate of around 500,000 different medical devices available whilst the number of IVD is estimated to be around 40,000 by the European IVD manufacturers association.

    From a public health point of view authorities need to have at their disposal consistent information about medical devices on the market. Many interested parties, in particular patients, healthcare professionals, Health Technology Assessment (HTA) bodies, insurers and third countries, consider the regulatory pathway of medical devices opaque and lacking in transparency since there is no access to key data regarding the characteristics, the clinical data and the conformity assessment path of certain medical devices, in particular implantable or other high risk devices.

    The scope of the European databank for medical devices (Eudamed) is limited and not accessible to the public (patients, healthcare professionals etc.). It requires the uploading of information by the competent authorities, which are in turn required to set up their own systems for collecting the data to be entered into Eudamed.

    Manufacturer of medium or higher risk devices, or their authorised representative, may also be required to notify the competent authorities of various member states when the device is sold in those countries, placing a considerable administrative burden on manufacturers and authorised representatives when they want to market a product in different member states.

    Changes included in the reforms to address this include:

    • Introduction of an EU portal where manufacturers must report serious incidents and corrective actions taken to reduce the risk of reoccurrence. The incidents and corrective actions are then automatically forwarded to the national authorities concerned
    • Where same or similar incidents have occurred, or where corrective action has to be taken in more than one member state, a coordinating authority will take the direction of coordinating the analysis of the case to reduce work and expertise sharing to avoid procedure duplication
    • Reinforce rights and obligations of the national competent authorities to ensure effective coordination of their market surveillance activities and to clarify applicable procedures
    • All manufacturers/authorised representatives and importers must register themselves and the device they place on the EU market in a centralised database
    • Manufacturers of high-risk devices to make publically available a summary on safety and performance with key elements of the supporting clinical data
    • Further development of the European databank on medical devices (Eudamed) which will contain integrated electronic systems on a European UDI, on registration of devices, relevant economic operators and certificates issued by notified bodies, on clinical investigations, on vigilance and on market surveillance. A large part of the Eudamed database will become publically available in accordance with the provisions regarding each electronic system
    • The centralised database will provide high level transparency, converge national registration requirements and lessen administrative burden on manufacturers.
  • Lack of harmonised traceability: Traceability of medical devices is currently not regulated by the medical devices directives. This has prompted some member states to impose traceability requirements on economic operators (manufacturers, importers, distributors, hospitals) at national or sometimes even at regional level through a Unique Device Identification (UDI) mechanism.

    Traceability contributes to enhance patient safety in cases where restrictive measures have to be taken on specific devices, such as a recall of products already placed on the market. It can also contribute to the fight against counterfeiting.

    The national systems, however, are not compatible with each other and do not allow traceability across borders which would be necessary for an EU-wide high level of patient safety. Moreover, products or their packaging need to be adapted to the different sets of rules. In addition, the UDI mechanisms are often linked to databases so that manufacturers have to enter data in different national (or even regional) databases as already described in the preceding section, thus increasing their administrative burden and hampering the internal market.

    Changes included in the reforms to address this include:

    • Clear conditions are set for enterprises involved in relabelling/repackaging for parallel traded medical devices
    • Patients who are implanted with a device should be given essential information on the implanted device allowing it to be identified, and containing any warnings or precautions that need to be taken; for example indication as to whether or not it is compatible with certain diagnostic devices or with scanners used for security control
    • Economic operators must be able to identify who supplied them and to whom they have supplied medical devices
    • Manufacturer's fit their device with a Unique Device Identifier (UDI) which allows traceability. The UDI system will be gradually implemented and proportionate to the risk class of the device
    • All manufacturers/authorised representatives and importers must register themselves and the device they place on the EU market in a centralised database
    • Manufacturers of high-risk devices to make publically available a summary on safety and performance with key elements of the supporting clinical data
    • Further development of the European databank on medical devices (Eudamed) which will contain integrated electronic systems on a European UDI, on registration of devices, relevant economic operators and certificates issued by notified bodies, on clinical investigations, on vigilance and on market surveillance. A large part of the Eudamed database will become publically available in accordance with the provisions regarding each electronic system
    • The centralised database will provide high level transparency, converge national registration requirements and lessen administrative burden on manufacturers.
  • Access to external expertise: The medical devices directives currently do not make provision for a structured involvement of external experts (e.g. healthcare professionals, academics) in the regulatory process. Notified bodies usually seek expert advice in the context of conformity assessment procedures but at EU level the dialogue on regulatory or safety issues usually takes place between regulatory authorities and manufacturers except in cases when a scientific opinion is sought from the Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR) on specific issues.

    Regulators, medical societies and manufacturers have expressed the need to better involve scientific and clinical experts in the dialogue and make their advice available in the regulatory decision-making process to keep pace with the innovation of products.

    Changes included in the reforms to address this include:

    • The central role in achieving harmonised interpretation and practice will be assigned to an expert committee (the Medical Device Coordination Group or MDCG) made up of members appointed by member states due to their role and experience in the field of medical devices and chaired by the commission. The MDCG and its subgroups will allow a forum for discussions with stakeholders. The commission will provide technical, scientific and logistical support to the MDCG
    • The introduction of MDCG creates the legal basis that for specific hazards or technologies, EU reference laboratories, may in the future be designated by the Commission
    • Notified bodies can notify the MDCG of new conformity assessment applications for high risk devices. The MDCG can request the notified body provide a preliminary assessment if on valid health grounds which the committee can comment on within 60 days. This allows authorities to have e second look at individual assessments before devices are placed on the market. Its use should be the exception rather than the rule and follow clear, transparent criteria
    • The Commission may set up a group of experts from various sectors (such as medical devices, IVDs, medicinal products, human tissues and cells, cosmetics and biocides) to determine regulatory status of borderline products.
  • Unclear and insufficient obligations and responsibilities of economic operators, including in the fields of diagnostic services and internet sales: The obligations of manufacturers and/or authorised representatives are clearly articulated in the current directives but often need to be deduced from requirements mentioned within the annexes, and the way these requirement are administered can vary between member states.

    Where authorised representatives act instead of a non-EU manufacturer with regard to the manufacturer's obligations under the directives, no minimum requirements currently exist and need to be established. As importers and distributors (including parallel traders and those selling over the internet) are currently not covered this leads to different levels of protection of patient safety and to obstacles to the internal market.

    Furthermore, uncertainties exist as to the application of the directives where (mainly) diagnostic devices, in particular IVD, are used to provide test results at a distance, either to a healthcare professional or directly to a consumer, without the diagnostic device itself being placed on the market or put into service in the EU. The problem also exists with regard to diagnosis made on the basis of medical imaging devices. There are increasing concerns regarding the validity and the reliability of the results provided at a distance and their understanding by lay users.

    Changes included in the reforms to address this include:

    • All manufacturers/authorised representatives and importers must register themselves and the device they place on the EU market in a centralised database.
    • Concerns also exist around sales of medical devices over the internet, particularly counterfeit products. Even though devices bought over the internet within the EU or Economic operators must be able to identify who supplied them and to whom they have supplied medical devices.
    • Manufacturer's fit their device with a Unique Device Identifier (UDI) which allows traceability. The UDI system will be gradually implemented and proportionate to the risk class of the device.
    • Further development of the European databank on medical devices (Eudamed) which will contain integrated electronic systems on a European UDI, on registration of devices, relevant economic operators and certificates issued by notified bodies, on clinical investigations, on vigilance and on market surveillance. A large part of the Eudamed database will become publically available in accordance with the provisions regarding each electronic system.
  • Management of the regulatory system: The management of the regulatory system at EU level has shown weaknesses which have been reported by various interested parties, i.e. healthcare professionals, patients, insurers, manufacturers and the media. It is considered as not sufficiently efficient and effective. There is no legal basis in the medical devices directives to ensure an overview of the situation at EU level and appropriate coordination between the member states. This is particularly an issue for identification of devices placed on the market, designation and monitoring of notified bodies, assessment of products, and vigilance and of market surveillance. In addition, there is no legal basis to ensure a gathering of expertise at EU level.

    This leads to a lack of uniform application of the rules and of common reactions in the European market, compromising both patient safety and the good functioning of the internal market. Efforts to achieve a certain degree of harmonised implementation have been made, such as informal working groups, however in the absence of any reference in the directives to the management of the system at EU level, the informal working groups produce guidance documents which serve a good purpose but cannot address fundamental issues.

    There is also no appropriate structure to ensure the sustainability and the efficiency of these activities, with the Commission having less than seven full time equivalent staff working on issues related to medical devices. There is a lack of:

    • administrative, technical and scientific support to the cooperation between member states
    • solid IT tools to manage the system
    • consolidated scientific and clinical expertise.

    A number of the changes outlined above also address the issues, such as introduction of cooperative monitoring between member states, and common tools such as the Eudamed and UDI requirements for devices.

Transition arrangements for the proposed changes include:

  • The changes are proposed to occur 3 years after its entry to allow manufacturers, notified bodies, and member states time to adapt to the proposals.
  • The 3 year period also allows for IT and organisational arrangements to be put into place.
  • Designation of notified bodies needs to occur shortly after entry into force of the Regulations to allow sufficient designated notified bodies to avoid medical device shortages in the market.
  • Transitional provisions are foreseen for the registration of medical devices, relevant economic operators and certificates issued by notified bodies to allow for smooth transition from registration requirements at national level to central registration at EU level.

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