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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/EEC, the EU’s directive on Active Implantable Medical Device 90/385/EEC, and the In Vitro Diagnostic Directive 98/79/EEC.

The MD IVD Regulations changes transition Impacts on ManufacturersFor the Medical Device Regulation (MDR), this regulation aims to ensure the smooth functioning of the internal 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 and Safety for Medical Devices in order to meet common Safety concerns as regards such products.

For the In Vitro Diagnostics Regulation (IVDR), the decision to regulate In Vitro Diagnostic devices through a regulation as opposed to a Directive will avoid differences in national interpretation that can lead to uneven implementation of the Directive. This 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

In the Medical Device Regulation (MDR):

The scope of the products will become broader to include Medical Devices which may not have the intended medical purpose or include devices for the purpose of prognosis of the a disease or any other health condition due to  the impact of the Medical Device Regulation (MDR) on the scope of the products.

In the In Vitro Diagnostics Regulation (IVDR):

To a large extent, the scope of the new In Vitro Diagnostics Regulation (IVDR) matches the scope of the In Vitro Diagnostic Directive 98/79/EC, i.e. it covers in vitro diagnostic medical devices. The proposed changes clarify and extend the scope to include high-risk devices manufactured and used within a single health institution, Genetic Testing, Companion Diagnostics and Medical Software.

Changes in the Clinical Investigation

In the Medical Device Regulation (MDR):

For class III and Implantable medical devices, as part of the requirements of the clinical evaluation, the Medical Device Regulation (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 many new concepts relating to clinical evaluation and clinical investigation, as well as a mandatory Post-Market Clinical Follow-up (PMCF) and Periodic Safety Update Reports (also known as PSURs). This will require a thorough review of the manufacturer’s Clinical strategy and PMCF plans and require manufacturers to conduct clinical performance along with providing evidence of Safety and Performance in accordance to the risk associated with the device and to collect Post-Market Clinical Data. With the new rules; the Medical Device manufacturers will need to perform a gap analysis to identify gaps in Clinical Evidence under new rules for devices currently on the market and perform the required update since the compliance to current MEDDEV 2.7.1 rev 4 without an update to the Clinical Strategy and performing the gap analysis may not be sufficient.

In the In Vitro Diagnostics Regulation (IVDR):

New requirements for In Vitro Diagnostics (IVDs) will include those for clinical evidence. 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.

In addition, the European Databank on Medical Devices (Eudamed) is expected to be expanded to provide more efficient access to information such as clinical investigations, Post-Market Surveillance (PMS), Vigilance… on approved medical devices.

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. 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 (RM) and Clinical Evaluation. The authority of the Notified Body will be increased with emphasis on Unannounced Audits (UAs), 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.

Common Specifications

The Medical Device Regulation (MDR) and In Vitro Diagnostics Regulation (IVDR) plan to allow the EU Commission or expert panels (to be defined) to publish Common Specifications which shall then be taken into account by manufacturers as well as Notified Bodies. These Common Specifications shall exist in parallel to the Harmonized Standards and the State of the Art. These specifications provide a means to comply with the general Safety and Performance requirements and the requirements for Performance Studies and Performance Evaluation and/or Post-Market Follow-Up. Common Technical Specifications currently exist for some high-risk In Vitro Diagnostics devices. It is likely this will be expanded.

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 (QMS) relating to Medical Devices or In Vitro Diagnostic Medical Devices.

The Expected Timeline for the Changes and How the Manufacturers Can Prepare

The timeline for the changes is dependent upon the successful conclusion of consultations between the EU commission, the EU Parliament and the EU Council, the final publication for both EU Medical Device and In-Vitro Diagnostics Regulations expected to be released no later than May 2017. The manufacturers of currently approved medical devices will have a transition time of three years to meet the requirements of the Medical Device Regulation (MDR). The In Vitro Diagnostics Regulation (IVDR) will apply 5 years after the date of publication.

It is expected the manufacturer to be proactive by building a plan and evaluating the impact on it organization with gap analysis to identify all changes per the regulation. The early planning and action from the manufacturer is the best way to ensure smooth transition to the new requirements.

 

In conclusion and to summarize
Gap Analysis: Manufacturers will need to carefully review the new rules for each device group and define a strategy to comply with the new requirements, they need to start developing a transition plan for their devices currently on the market to be re-certified under the new rules: technical files will need to be revisited, additional clinical evidence generated and declarations of conformity amended.

Manufacturers shall check if their device(s) fall(s) under the new Medical Devices or In Vitro Diagnostic Regulations.

Manufacturers shall check if re-classification is applicable.

Manufacturers shall assess and follow the new Conformity Route Assessment requirements.

Manufacturers should start discussions with their Notified Body about their plan and timeframe for transition

For the new devices, manufacturers must decide whether they want to comply with the new rules already during the transitional period or when that period expires. A pro-active approach is needed as both the Medical Device and In Vitro Diagnostics Regulations will require (more) clinical evidence on device to be certifified, especially for higher risk devices, which will take time to generate.

 


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