The finalisation of the new EU Medical Device Regulations has long been awaited since the "Trilogue" procedure between the European Commission, European Council and the European Parliament ended in July 2016.
That time has now come. The European Parliament adopted proposals for two new EU Regulations on medical devices on 5 April 2017 – one for medical devices and the other for in vitro diagnostic medical devices. This effectively ends the legislative procedure, meaning that the legislation is now in final form and can proceed to becoming law by their publication in the Official Journal of the European Union (OJEU).
Why are new Regulations needed?
The legal framework governing medical devices in the European Economic Area (EEA) is principally governed by three Directives, which date from the 1990s:
- Council Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices (AIMDD)
- Council Directive 93/42/EEC of 14 June 1993 concerning medical devices (MDD)
- Directive 98/79/EC of 27 October 1998 on in vitro diagnostic medical devices (IVDD).
We refer to these Directives collectively in this article as the Medical Devices Directives.
The reason provided in the recitals to the new Regulations as to why the Medical Devices Directives required a significant overhaul, was the need to "establish a robust, transparent, predicable and sustainable regulatory framework for [medical devices and in vitro diagnostic medical devices] which ensures a high level of safety and health whilst supporting innovation".
This need for change was particularly highlighted by the highly publicised PIP breast implant scandal and the unexpected early failure of certain metal-on-metal hip implants, which flagged the need for greater scrutiny of medical devices and patient safety.
The number countries within the EEA has also grown since the Medical Devices Directives were introduced and there had been significant technological and scientific advancements and substantial divergences in the interpretation and application of the legislation.
This was viewed by the European legislators to have undermined the safety of medical devices and their free movement within the EEA. There were also uncertainties over the regulation of certain products, such as those for non-medical but cosmetic/aesthetic purposes.
The new Regulation on medical devices (MDR) essentially repeals and replaces the MDD and the AIMDD, and the new Regulation on in vitro diagnostic medical devices (IVMDR) repeals and replaces the IVDD.
What are the main changes?
As noted in the Recitals to the new MDR:
"key elements existing regulatory approach, such as the supervision of notified bodies, conformity assessment procedures, clinical investigations and clinical evaluation, vigilance and market surveillance should be significantly reinforced, whilst provisions ensuring transparency and traceability regarding medical devices should be introduced, to improve health and safety".
Similar wording appears in the Recitals to the IVMDR.
The changes introduced in both the MDR and IVMDR include:
- A new European database on medical devices (EUDAMED) that will collate and process information regarding devices on the market and the relevant economic operators (eg manufacturers), certain aspects of conformity assessment, notified bodies, certificates, clinical investigations, vigilance and market surveillance. Much of the information on the database is to be made accessible to the public and the European Commission is tasked with setting it up by spring 2020.
- A new Unique Device Identification (UDI) system that would improve post-market vigilance and traceability of devices.
- Greater supervision of notified bodies. Notified bodies will have to meet higher requirements regarding their organisational structure, competence, skilled personal and appropriate level of liability insurance. The supervisory position of national Competent Authorities will also be increased. Additionally, notified bodies dealing with high-risk devices will be obliged to request an opinion of an independent expert panel before final certification of such products (see the so-called "Scrutiny-procedure" described below).
- The position of notified bodies with respect to manufacturers is strengthened. This includes notified bodies' rights and duties to carry out unannounced on-site audits and to conduct physical or laboratory tests on devices to ensure continuous compliance by manufacturers after the original certification.
- Manufacturers are mandated to have measures in place to provide sufficient financial coverage in respect to their potential liability for defective devices. The coverage must be in a manner that is proportionate to the risk class, type of device and size of the enterprise. Manufacturers are not generally obliged to have liability insurance in place, unlike notified bodies.
- Pre-market assessment procedure (so called Scrutiny-procedure) will be mandatory for high-risk products (eg implantable Class III devices and certain Class IIb active devices). The Scrutiny-procedure requires the notified body to inform the Competent Authorities and the European Commission through EUDAMED about the initiation of the process. The notified body prepares a Clinical Evaluation Assessment Report (CEA), setting out its conclusions regarding the clinical evidence provided by the manufacturer. Once the European Commission has forwarded the CEA to an expert panel, the expert panel decides within 21 days whether it will provide an additional scientific opinion.
Additional changes introduced by the MDR include:
- An implant card and information must to be provided by the manufacturer of an implantable device. The implant card must be provided to the patient and contain information allowing the identification of the device, including the device name, serial number, lot number, the UDI, the device model, together with name, address and the manufacturer's website. Updates of the information on the implant card must be made available to the patient through the manufacturer's website. Additional information must also be provided on the manufacturer's website such as certain warnings and precautions to be taken by the patient or a healthcare professional, expected lifetime of the device and safe use of the device.
- Tightening of the rules on clinical evaluations and clinical investigation and greater transparency of the outcome. The conduct of a clinical trial will, as a general rule, become an essential requirement for the marketability of Class III devices and implantable devices. The changes indicate some alignment with the regulatory framework that applies to medicines. In addition, manufacturers of implantable devices and for Class III devices are required to disclose the safety and performance aspects of the device and the outcome of the clinical evaluation to Competent Authorities, some of which will be accessible by the public.
- New rules on reprocessing of single-use devices. Reprocessing will only be permitted where it is lawful under national law and complies with the requirements of the MDR. Where reprocessing is permitted, the entity wishing to reprocess will be considered to be the manufacturer of the reprocessed device and will assume the same obligations as the original manufacturer, but the national law may provide for exceptions regarding the re-use within a health institution.
- Certain products with only an aesthetic or other non-medical purpose that were not previously regulated as medical devices, will be subject to the new legislation if their functioning and risk profile is similar to medical devices. Such products will include non-corrective colour contact lenses, dermal or facial fillers, equipment used for liposuction, certain lasers and intense pulsed light equipment for tattoo or hair removal.
- Devices composed of substances intended to be introduced in the human body via a body orifice or applied to the skin will no longer fall within Class I, but as a general rule in Class III and exceptionally in Class IIa or IIb, if they are applied to the skin or in the nasal or oral cavity (eg nasal spray or cough drops).
The changes introduced by the IVMDR include:
- A new classification system. The IVMDR introduces 4 classes of device, in increasing order of their risk profile: Class A, B, C and D. In general terms, conformity assessment is carried out by the manufacturer in respect of Class A devices and notified bodies in respect to Class B, C and D.
- Clearer rules that all tests that provide information on the predisposition to a medical condition or disease (eg genetic tests) and tests that provide information to predict treatment response or reactions (eg companion diagnostics) are in vitro diagnostic medical devices.
- Tightening of rules on clinical evidence. Clinical performance data providing sufficient clinical evidence is required in the conformity assessment of all in vitro diagnostic devices. Clinical evidence, as a general rule, must be sourced from performance studies, unless clinical performance data can be generated by reliance on other adequate sources. The new rules include an obligation on the manufacturer to specify and justify the level of the clinical evidence necessary to demonstrate conformity with the relevant general safety and performance requirements. That level of clinical evidence must be appropriate in view of the characteristics of the device and its intended purpose. Clinical evidence must support the intended purpose as stated by the manufacturer and be based on a continuous process of performance evaluation, following a performance evaluation plan.
When will the new Regulations apply?
The new Regulations will come into force 20 days following their publication in the OJEU, which is expected to take place in the next couple of months. However, they will apply from their respective dates of application; the MDR will apply three years after entry into force, whereas the IVMDR will apply five years after its entry into force.
Can medical devices authorised under the Medical Devices Directives be sold after the new Regulations come into force?
Two things need to be considered in addressing this question:
- the validity of conformity assessment certificates granted under the Medical Devices Directives
- devices placed on the market before or during the transition period.
Validity of certificates
Certificates granted under the Medical Devices Directives will remain valid for a transitional period as follows:
- If issued before the date of entry of the relevant Regulation, the certificate will remain valid until the end of the period indicated on the certificate. Except for those issued in accordance with Annex 4 to the AIMDD, Annex IV to the MDD or Annex VI to the IVDD, which shall become void at the latest on two years from the date of application of the relevant Regulation.
- If issued after the date of entry of the MDR, certificates for medical devices and active implantable medical devices under the MDD and AIMDD will remain valid until the end of the period indicated on the certificate, which must not exceed five years from its issuance. All such certificates will become void at the latest four years after the date of application of the MDR.
- If issued after the date of entry of the IVMDR, certificates for in vitro diagnostic devices under the IVDD will become void two years after the date of application of the IVMDR.
Devices on the market during the transition period
The transition measures in the new Regulations provide for a "run off" period for devices which are or will be lawfully placed on the market under the Medical Devices Directives. These devices may stay on the market for the following transitional periods:
- Devices with a certificate issued in accordance with the MDD or AIMDD may be placed on the market or put into service, provided that from the date of application of the MDR those devices continue to meet the requirements of the MDR, MDD or AIMDD (as appropriate) and there are no significant changes in their design or intended purpose.
- Devices already lawfully placed on the market in accordance with the MDD or AIMDD prior to the application of the MDR or after the application of the MDR, but based on a valid certificate, may continue to be made available on the market until five years after the application of the MDR. The period for devices authorised under the IVDD is three years after the date of application of the IVMDR. As the certificates for such devices may become void before the end of these periods, the mechanism essentially operates as a short "run off" period.
- Regarding post-market surveillance, vigilance and the registration of economic operators and devices under the MDR and IVMDR will apply to any device placed on the market upon the date of application.
Devices which comply with the MDR and IVMDR may be marketed upon the entry into force of the relevant legislation.
What about the role of notified bodies?
Notified bodies are independent conformity assessment entities engaged by medical device manufacturers, which are authorised by Competent Authorities to conduct certain pre- and post-market assessment activities.
When seeking a certification of a medical device in compliance with the new Regulation, it should be noted that a notified body who is authorised under the Medical Devices Directives, cannot issue a certificate under the new legislation unless the notified body meets the requirements that apply to it under the relevant Regulation (ie MDR and/or IVMDR).
As discussed above, notified bodies will have to meet higher requirements regarding their organisational structure, competence, skilled personnel and appropriate level of liability insurance. For example, personnel responsible for carrying out product-related reviews (eg reviewing technical documentation reviews or examination) or audits of a manufacturer's quality management system, must satisfy specific educational and experience requirements.
The authorisation of a notified body under the Medical Devices Directives will become void from the date of application of the MDR and IVMDR. Notified bodies must therefore take steps at an early stage to ensure that they meet the more stringent requirements under the new Regulations.
As the notified body who issued a certificate in accordance with the Medical Devices Directives remains responsible for the appropriate surveillance, the question remains what will happen if a notified body does not meet the requirements under the new legislation by the relevant deadline.
What should manufacturers of medical devices do to prepare?
The transitional provisions of the MDR and IVMDR do not exempt medical devices that have a certificate of conformity. These medical devices will need to be re-evaluated and re-approved before the expiry of the relevant transition periods.
Medical device manufacturers should therefore consider the implications of the new Regulations at an early stage rather than waiting to near the end of the transition periods.
Consideration should also be given to existing supply chain agreements and the obligations and liabilities of the various stakeholders (eg manufacturers, importers and distributors). Manufacturers should also review their contracts with notified bodies.
Certain non-medical, aesthetic products will be regulated as medical devices under the new legislation. This means that it will become unlawful to place such products on the market within the EEA unless they meet the requirements of the MDR. Companies manufacturing such products should consider whether their products would fall within the scope of the new Regulation.