Medical Device Regulation – MDR 2017/745 Consulting Service

  • Medical Device Regulation – MDR 2017/745 Consulting Service

    With our team of SMEs and Regulatory experts we provide support to companies in different fields and with different kind of products going through the changes introduced by new MDR.

    Medical devices are medical equipment and devices for in vitro tests used either in hospitals by health professionals or directly by the patient. There are over 500,000 types of medical devices and devices for in vitro tests on the EU market.

    These cover a wide range of products from home-use items like sticking plasters, pregnancy tests and contact lenses to x-ray machines, pacemakers, breast implants, hip replacements and blood tests.

    On 5 April 2017, 2 new Regulations on medical devices were adopted. These replace the existing Directives.

    • Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC
    • Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU

    Transition period

    • MDR – 3 years after entry into force for the Regulation on medical devices (spring 2020)
    • IVDR – 5 years after entry into force (spring 2022) for the Regulation on in vitro diagnostic medical devices.

    MDR Time line

    • April 5, 2017: The EU Medical Device Regulation was adopted.
    • May 5, 2017: The Regulation was published in the Official Journal of the European Union.
    • May 26, 2017: The Regulation entered into force and will apply in parallel with the current medical devices directive MDD 93/42/EEC for a transition period of three years.
    • December, 2017: The process of re-designating Europe’s Notified Bodies under the new regulation begins. The first designations are expected to be finalized some 12 to 18 months from the date of publication of the legislation.
    • May 25, 2020: The transition period ends and the Medical Devices Regulation becomes mandatory.

    The Commission welcomes the adoption of its proposal for 2 Regulations on medical devices which establish a modernised and more robust EU legislative framework to ensure better protection of public health and patient safety.

    Some Points to keep in Mind

    UDI

    The Unique Device Identification (UDI) System is intended to allow the identification and facilitate the traceability of medical devices within the distribution chain. Manufacturers must assign a single product identifier to each product; this UDI shall appear in the technical documentation, the EU declaration of conformity and on the label or the packaging of the device. The information must be shared with the UDI database and is used to report problems in the field and also should help to reduce medical errors and to fight against falsified devices.

    EUDAMED

    The acronym stands for European Database on Medical Devices. It is designed to collect information that can be shared among member states, the EU commission, notified bodies, economic operators and sponsors on marketed medical devices, conformity assessment procedures, Notified Bodies, certificates, registered economic operators, vigilance/adverse events, market surveillance and clinical investigations.

    TECHNICAL FILE

    Requirements are much more detailed regarding both content and regular updates of technical documentations and there is an increased focus on clinical assessments. Importantly, there will be no differentiation between class III documentation (MDD: design examination file) and the other classes.

    CLINICAL EVALUATION

    The MDR has increased requirements for further and on-going clinical data before a device can be CE Marked. The amount of clinical data necessary for each device classification is proportionate to the amount of risk associated with intended use. High-risk devices such as class III and implantable medical devices will require more clinical data for approval.

    MEDICAL DEVICE SOFTWARE

    According to the new rule 11 (chapter VIII) software intended to provide data used for diagnostic purposes or to make therapeutic decisions now belongs to class IIa. In certain cases the software may even be classified into IIb or III.

    The main reasons behind this change

    Problems with diverging interpretation of the current Directives as well as some incidents with breast implants and metal hips highlighted the weaknesses of the current legal system and damaged the confidence of patients, consumers and healthcare professionals in the safety of medical devices. Such problems should not occur again and the safety of all medical devices available in the EU has to be strengthened. Moreover, revision of the legislation was necessary to consolidate the role of the EU as a global leader in the sector over the long-term and to take into account all technological and scientific developments in the sector.

    The new regulations will ensure:

    • a consistently high level of health and safety protection for EU citizens using these products
    • the free and fair trade of the products throughout the EU
    • that EU legislation is adapted to the significant technological and scientific progress occurring in this sector over the last 20 years.

    The new Regulations contain a series of extremely important improvements to modernise the current system. Among them are:

    • stricter ex-ante control for high-risk devices via a new pre-market scrutiny mechanism with the involvement of a pool of experts at EU level;
    • the reinforcement of the criteria for designation and processes for oversight of Notified Bodies;
    • the inclusion of certain aesthetic devices which present the same characteristics and risk profile as analogous medical devices under the scope of these Regulations;
    • the introduction of a new risk classification system for in vitro diagnostic medical devices in line with international guidance;
    • improved transparency through the establishment of a comprehensive EU database on medical devices and of a device traceability system based on Unique Device Identification;
    • the introduction of an “implant card” containing information about implanted medical devices for a patient;
    • the reinforcement of the rules on clinical evidence, including an EU-wide coordinated procedure for authorisation of multi-centre clinical investigations
    • the strengthening of post-market surveillance requirements for manufacturers;
    • improved coordination mechanisms between EU countries in the fields of vigilance and market surveillance.

    Medical Device Regulation – Guidance Documents

    Following guidance document were issued to provide further clarity on new regulatory changes and implementation models:

    Doubts about new MDR ?

    Reach out to us and we will help you clarify your situation

  • Doubts about new MDR ?

    Reach out to us and we will help you clarify your situation