(May 1, 2017)
The Medical Device Regulation (MDR) and the In Vitro Diagnostics Regulation (IVDR) were initially proposed in 2008 when the EU Commission triggered a consultation on the community’s existing requirements covering medical devices. The plan was 1st released by the commission in 2012 to modify the EU’s medical device regulatory framework along with a proposed regulation replacing the EU’s current Medical Device Directive 93/42/EC,the EU’s directive on Active Implantable Medical Device 90/385/EC, and the In Vitro Diagnostic Directive 98/79/EC.
Medical Device Regulation (MDR). This regulation aims to ensure the smooth functioning of the internal EU market in regard Medical Devices, taking as a base a high level of protection of health for patients and users. At the same time, this regulation sets high standards of Quality, Safety, and Performance for Medical Devices in order to meet common Safety concerns as regards such products.
In Vitro Diagnostics Regulation (IVDR). This regulation will avoid differences in national interpretation, and will also strengthen Patient Safety through the introduction of more stringent procedures for Conformity Assessment, Post-Market Surveillance and through requirements to generate Clinical Data providing Evidence on Safety, Performance and any Undesirable side-effects. This should also allow rapid and cost-efficient market access for Innovative Medical Devices.
The Main Proposed Changes in the Regulations: Wider, Clearer scope of the products covered
Medical Device Regulation (MDR):
The scope of the products will become broader to include Medical Devices which (a) may not have the intended medical purpose or (b) include devices for the purpose of prognosis of the a disease or any other health condition due to the impact of the MDR on the scope of the products.
In Vitro Diagnostics Regulation (IVDR):
The scope of the IVDR matches the scope of the In Vitro Diagnostic Directive 98/79/EC has not significant changed, but changes can be found extended requirements on risk classification and mandatory conformity assessment of high-risk devices by accredited notified bodies. Assessment of the technical file will be focused on i.e. performances, clinical evidence of i.e. genetic testing devices, companion screening and diagnostic devices, and medical software.
Changes in the Clinical Investigation
In the Medical Device Regulation (MDR):
For class III and Implantable medical devices the MDR will put in place a European regimen for clinical investigations that will replace the diversity of member state regulations in the EU. It will introduce several concepts relating to clinical evaluation and clinical investigation, as well as a mandatory Post-Market Clinical Follow-up (PMCF) and Periodic Safety Update Reports (PSUR’s). This will require
- a thorough design and review of the manufacturer’s Clinical Strategy and PMCF plans
- to conduct clinical performance
- providing evidence of Safety and Performance in accordance to the risk associated with the device and
- to collect Post-Market Clinical Data.
With the MDR rules, the manufacturer will need to perform a gap analysis to identify gaps in Clinical Evidence to be in compliance of MEDDEV 2.7.1 rev.4.
In the In Vitro Diagnostics Regulation (IVDR):
It will be necessary to collect clinical evidence for all IVD devices. Clinical evidence is defined as clinical data and Performance Evaluation results pertaining to the device of sufficient amount and quality to allow a qualified assessment of whether the device achieves the intended Clinical Benefit(s) and Safety, when used as intended by the manufacturer.
Unique device identification (UDI)
In the Medical Device Regulation (MDR) and In-Vitro Diagnostics Regulation (IVDR):
In order to improve the ability of the authorities and manufacturers to trace the specific devices through the supply chain and to smooth the recall process of Medical Devices that have been found to present a safety risk, the proposed Medical Device Regulation (MDR) and In-Vitro Diagnostics Regulation (IVDR) mandates the use of Unique Device Identification (UDI) mechanisms.
Provisions regarding registration of devices and economic operators, in particular those governing the Unique Device Identification system have been complemented and clarified. They should lead to the establishment of a more functional system related to Identification and Traceability of devices, while maintaining alignment with international principles and practices in this field.
Classification and Conformity Assessment
In the Medical Device Regulation (MDR):
There will be an impact on the classification for certain medical devices; reclassification of the medical devices to a higher risk class is possible such as for some reusable surgical instruments. However, the MDR reclassification is mainly impacting class II implants (class III if they come into contact with the spinal column (rule 8)) and substance-based medical devices.
The review of the lower risk devices will be highly enforced on Clinical Evaluation so the manufacturer should revisit the content of the current Technical Documentation as there will be an impact on the existing Quality Systems and to take into account the changes in the conformity assessment rules, the Regulation will feature new essential Safety and Performance requirements for example.
In the In Vitro Diagnostics Regulation (IVDR):
The classification system of the regulation has been adapted to correspond to the rapid increase in scientific, medical and technical knowledge and to the resulting development of more advanced devices. The regulation introduces new risk-based classification rules for IVD devices and is therefore less arbitrary that the current classifications in the IVD Directive. This will allow room for changes and emerging technology. For example, infectious disease, cancer screening and congenital screening will now fall under Class C devices. These devices will require input from the Notified Body, whereas in the past many of these products were self-declared by the manufacturer. In addition, the provisions on Conformity Assessment have been clarified but continue to be based on the existing well-established system. However those provisions on assessment of high-risk devices have been considerably strengthened with a view to patient safety. Requirements have also been included for Competent Authority (CA) consultation in the case of Companion Diagnostics.
Impact on the Post Market Activities
In the Medical Device Regulation (MDR):
The major change in this process is mainly driven by the request of real-life data for the Post-Market Clinical Performance Evaluation (PMCF). Its results must be taken into account for Clinical Evaluation and Risk Management update.
The manufacturer will need to review their current Post-Market Surveillance (PMS) and Vigilance procedures with evaluation linked to the review of the Risk Management and Clinical Evaluation. The National Competent Authority of the Notified Body will be increased with emphasis on Unannounced Audits, along with product sample checks and product testing. Annual Safety and Performance reporting by device manufacturers will also be required in many cases.
In the In Vitro Diagnostics Regulation (IVDR):
Although Vigilance and Post-Market Surveillance (PMS) have always been a requirement, there are more prescriptive measures laid out in the new Regulation which includes specific direction on the use of data gathered by the manufacturer's Post-Market Surveillance system. In addition there will be new documentation requirements such as Periodic Safety Update Reports (PSURs) with additional requirements based on the device classification.
Identification of Qualified Person (QP)
At least one person must be assigned within the organization that should be responsible for all aspects of compliance with the requirements of the Medical Device Regulation (MDR) and In Vitro Diagnostics Regulation (IVDR). The qualifications of this individual must be documented and be available upon request. The qualifications of this person can be demonstrated by evidence of formal qualification awarded on the completion of a university degree or of a course of study recognized as equivalent by the Member State concerned. The Qualified Person must also have at least one year of professional experience in Regulatory Affairs or in Quality Management Systems (i.e. ISO 13485).
Expected timeline for the changes and how you as manufacturer can prepare
The timeline for the changes is dependent upon the final publication (probably May-June 2017). As independent professional and recognized quality and regulatory service provider we’re qualified and able to support you in your efforts to be in full compliance with the MDR and or IVDR requirements.
We’re looking forward to provide you guidance in the challenges you are facing as individual company what you may use as proactive evidence to present to your notified body during coming scheduled audit.