In Brief

• For long, medical device regulations continued to remain stagnant till such time that the world was struck with the hip replacement and breast implant crisis.
• The new EU-MDR and EU-IVDR brings in more stringent regulations, drastically modifying the way in which medical device manufacturers operate. The new regulations have also modified several device classes that were previously quite lenient into classes that now require strict review and evaluation. It also takes into its ambit accessories to medical devices that were previously unregulated.  

Right from the early 1990s, there has hardly been any changes in terms of regulation of the medical device industry within Europe. Nonetheless, owing to some incidents during the recent past, comprising of the crisis revolving around hip replacements and breast implants has now incited the need for stringent compliance and regulatory reforms within the industry. The most prominent amongst all regulations were the European Commission’s 2012 proposal for regulation on medical devices (EU-MDR) and in-vitro diagnostics (EU-IVDR). With the publication of guidance in a formal manner very imminent, the proposal intends to offer national regulators with a control that is much more superior and also provide any inherent oversights within the medical devices sector, while rendering it mandatory to conform to the new regulations (Doloitte, 2016). In the event that medical device manufacturers fail to conform to the changes, it would most probably lead to the medical device manufacturer forfeiting its manufacturing license.

The impact that would be created by the new EU-MDR could bring about drastic modifications to the manner in which medical device manufacturers function. So much so, that it has the potential to make an impact on the composition of the device manufacturers current as well future portfolios. Further, conforming to the regulations would also result in substantial costs. Therefore, it becomes imperative that device manufacturers act now in order to acquire buy-in by stakeholders, ready their organizations and commence with adopting the suggested modifications.

The new EU-MDR 2017/745 brings legislation in EU at par with technical developments, modifications within medical science and advancements in terms of law-making. Implementation of the new EU-MDR would eventually establish a regulatory framework that is transparent, robust and sustainable, which will receive global recognition, thereby enhancing clinical safety and facilitates manufacturers with an access to market which is fair. In contrast to directives, it is not necessary to transpose regulations within national law. Thus the new EU-MDR would restrict any discrepancies in terms of interpretation throughout the EU market (European Commission, 2020). It can be thus said that the new EU-MDR is preparing the medical devices market for the future. However, there are aspects that medical device manufactures need to take into consideration in preparation of the future.

Preparing for the Future

The European Commission has of late published five documents with the intention of providing guidance to manufacturers as well as other economic operators with regards to the changes effected through the new EU-MDR and EU-IVDR which are due to be in-force from May, 2020 and May, 2022 onwards respectively. The said guidance related documents comprise of implementation models as well as factsheets for medical device manufacturers as well as in-vitro medical device manufacturers, along with an extensive list of requirements for medical device manufacturers (Grow, 2020). Those manufacturers who have not commence execution of the new EU-MDR can refer to these guidance documents as an initial roadmap, whereas, those manufacturers who have already progressed with the execution can refer to it as a checklist in order to ensure that they cover all steps within their plan of action.

The factsheet concentrates on key modifications as outlined by the EU-MDR and provides insights on the scope of the EU-MDR, definitions, obligations of manufacturers, class of risks for devices, notified bodies, system of identification of new devices, evaluation of adherence, along with clinical needs and a brief of clinical and safety performance. It offers vital points on the EU-MDR background, modifications executed through the new regulations and practical outcomes and the timelines for making the modifications. In addition, the guidance document also presents answers to some basic operational queries.

Furthermore, what needs to be taken into consideration is that the new EU-MDR outlines strict requirements for designating notified bodies (Grow, 2020). Also, the new EU-MDR has an extended scope and takes into its ambit more devices such as; devices for cleaning, sterilizing or disinfecting other medical devices, medical devices for single use that are reprocessed and some specific devices that have no intended medical purpose. Moreover, certain devices have also been reclassified on the basis of risk analysis while introducing a procedure of consultation on clinical evaluation. This is purportedly executed by a panel of independent experts for certain classes of devices (class IIb) and for devices falling under the implantable (class III) category (Grow, 2020). 

Approach to EU-MDR Conformity

Considering the intricacy and extent linked with executing the new EU-MDR, it is imperative that manufacturers adopt a cross-functional approach which extends across the enterprise. Essentially, there would be three steps to execute and adhere to the new EU-MDR and acquiring conformity.

Acquiring and in-depth understanding of the EU-MDR and EU-IVDR (Step – 1)

It would be necessary that medical device manufacturers have an enhanced understanding of the new EU-MDR, its overall impact and scope on their business. Several manufacturers would be having an amalgamation of products therefore the proposed modifications make sense. It would also be significant to comprehend any overlap with other pertinent directives and regulations such as clinical trial regulation (CTR) for human use and IVD etc.

Review and Evaluation of Medical Device Portfolio (Step – 2)

The entire gamut of products manufactured by a manufacturer needs to be necessarily evaluated and reviewed in line with the EU-MDR and requirements of the future. For instance, as per the new regulation those products that have been categorized as accessories would fall under the ambit of medical devices. There is also scope that as per new requirements, classification status of certain products might change. It would be imperative to understand whether such products need to be up-classified in future and its corresponding impact (Doloitte, 2016).

Strategy and Roadmap for new EU-MDR (Step – 3)

Following the complete review and evaluation of the product portfolio as per the existing and future states, it would be possible to define gaps. Such gaps can be necessarily categorized as tactical and strategical projects, which can be prioritized on the basis of legal, business and regulatory drivers.

To structure a regulatory strategy for affecting the new EU-MDR, there is a need for device manufacturers to define a logical sequence of activities. This warrants the need for an approach that is multi-level and would comprise of; impact evaluation of the highest levels, planning, execution and organizational alignment, communication and realization of benefits.

Future Scope

In future, medical devices that have not been covered under EU-MDR such as products that are known to utilize viable biological components for its intended purpose should also be included under the ambit of EU-MDR and EU-IVDR.

References

1. Doloitte (2016). Taking charge of the new medical device regulatory environment: From complex regulation to impactful change. [Online]. 2016. Available from: https://www2.deloitte.com/content/dam/Deloitte/global/Documents/Life-Sciences-Health-Care/gx-eu-med-device-regulation.pdf.


2. European Commission (2020). Internal Market, Industry, Entrepreneurship and SMEs. [Online]. 2020. Available from: https://ec.europa.eu/growth/sectors/medical-devices/regulatory-framework/getting-ready-new-regulations_en.


3. Grow (2020). Factsheet for manufacturers of medical devices. [Online]. 2020. European Commission. Available from: https://ec.europa.eu/docsroom/documents/31201.

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In Brief

• Different medical devices have different parameters through which it can be classified. With that reasoning, it does not make sense to subject all medical devices to stringent conformity assessments.
• Moreover, the onus of classifying a medical device is the responsibility of the medical device manufacturer. The device manufacturer has to be aware about the class under which their device will fall under, right from the time the device is in the process of development.

Philosophy of Medical Device Classification

In terms of practice it cannot be economically justified nor is it feasible to make all medical devices go through every stringent assessment in terms of conformity. A system of control which is graduated should be more than enough. Under the tenets of such a system, the degree of control matches with the degree of possible risks innate within a specific device type. This warrants the need for a system for classifying medical devices. This ensures that medical devices are applied through the required process for evaluating conformity (Wheeler, 2018). With a view to ensure that evaluation of conformity as per the European Union Medical Device Directives operates in an effective manner, it is imperative that manufacturers are in a position to determine the category under which their devices will classified right from the very initial developmental phase of the device. Thus, the need was felt to establish a system of rules for device classification as under the Directive. This would allow all device manufacturers to classify their own devices.

The system of classification of medical devices is based on risk on the basis of susceptibility of the human body while keeping in mind the potential hazards linked with the device. An approach of such kind facilitates the utilization of a preset criterion that could be amalgamated in diverse manners with a view to determine classification (Global Legal Research Center, 2014). For eg., the time period during which the device is in contact with a human body, the level of the device’s invasiveness and systemic vs. local effect. Such criterions could then be applied to an extensive array of diverse medical devices and technologies. These are commonly termed as the rules for classification and have been outlined within Annex IX of Directive 93/42/EEC. To a large degree, it matches to the rules of classification setup by the Global Harmonization Task Force (GHTF) within the guidance document GHTF/SG1/N15:20063.

Prior to a medical device being legally classified by manufacturers as ‘CE’ within Europe, it is mandatory that they adhere to the appropriate medical device directive or regulation as outlined by the European Commission (EU). It is critically very significant to be aware of the appropriate medical device classification for a particular product prior to placing a ‘CE’ mark on the device. Regulatory requirements are impacted through device classification and also the route for approval along with associated costs (French-Mowat & Burnett, 2012).

Medical Device Classification in Europe

The initial step within the regulatory process in Europe would be to determine the directive that is applicable to a particular product. A large number of devices fall under the medical device directive 93/42/EEC, however, there are certain high risk devices such as implantable devices that needs to adhere to the Active Implantable Medical Devices Directive (AIMDD) 90/385/EEC. At the same time, the In Vitro Diagnostic Directive (IVDD) 98/79/EC is applicable to In Vitro Devices (IVDs) (HPRA, 2009). In case, a manufacturer opts to project adherence to regulation, the Medical Device Regulation (MDR) No. 2017/745 (for active implantable devices or medical devices), or the In Vitro Diagnostic Device Regulation (IVDR) No.2017/746 would be taken into account. A rule based scheme of classification is utilized by Europe for medical devices which fall under the ambit of MDD. There are around 18 rules which have to be adhered to and these can be referred to in Annex IX of the MDD. Though the overall structure of the rules from MDD is maintained in the MDR, there is scope for expanding the rules (McDonough, 2019).

Segmentation of Medical Devices within Europe

On the whole, every medical devices can be segmented into four key categories. These would include;

• Non-invasive medical devices
• Invasive medical devices
• Active medical devices
• Special Rules (comprising of disinfectant, contraceptive and radiological diagnostic medical devices) or devices comprising of animal tissue or drug-device combination.

The above said 18 rules as specified within Annex IX of the Directive and pertinent regulation lay down the fundamental principles for classification. As per MEDDEV 2.4/1 Rev.8, such rules are additionally elucidated with descriptive samples. The 18 rules are further bifurcated into four groups.

Furthermore, the MDR has also framed certain special rules that also cover Nano-materials (Donnell, 2016). Medical devices are further segmented as per the classes as mentioned below. IVDs are known to have their individual scheme of classification whereas, active implantable medical devices fall under the scope of similar requirements as that of class III devices (the MDR also includes active implantable medical devices).

• Class I – Provided non-sterile or devices that are devoid of a measuring feature (low risk)
• Class I – Provided sterile and / or is inclusive of a measuring feature (low/medium risk); to this group reusable surgical instruments as Class I reusable surgical instruments have been added by the MDR.
• Class IIa – (medium risk)
• Class IIb – (medium or high risk)
• Class III – (high risk)

When to apply the Health Products Regulatory Authority (HPRA) for Determining Classification

As mentioned above, it is the responsibility of the device manufacturer to determine the right class for their product. Subsequently, the basic responsibility for device classification rests on the manufacturer. The manufacturer is supposed to confirm classification with a Notified Body (NB) of their preference. In case there is uncertainty or any kind of difference of opinion between the manufacturer and the NB, it is essential to refer the issue to a competent authority for arriving at a decision (HPRA, 2009). The HPRA also accepts formal requests on the part of the manufacturer for classifying a medical device, drug-device combination and borderline product before submitting an application for CE marking to a NB or before notification pertaining to the register of Class I devices. Formal requests for classification are also accepted by the HPRA from other interested parties or individuals. All interested parties can download the relevant form ADV-F0006 for medical device classification, from ‘publications and forms’ section of the HPRA website.

References

1. Donnell, M.O. (2016). Nanomaterials and medical device regulations Nanomaterials. [Online]. Available from: https://www.bsigroup.com/globalassets/meddev/localfiles/en-gb/webinars/bsi-md-nanomaterials-presentation-30-nov-2016.pdf.


2. French-Mowat, E. & Burnett, J. (2012). How are medical devices regulated in the European Union? Journal of the Royal Society of Medicine. [Online]. 105 (1_suppl). pp. 22–28. Available from: http://journals.sagepub.com/doi/10.1258/jrsm.2012.120036.


3. Global Legal Research Center (2014). Approval of Medical Devices. [Online]. 6462 (September). pp. 23. Available from: www.law.gov.


4. HPRA (2009). Guide to Classification of a Medical Device. Health Products Regulatory Authority. [Online]. 1 (1). pp. 3–11. Available from: https://www.hpra.ie/docs/default-source/publications-forms/guidance-documents/adv-g0004-guide-to-classification-of-a-medical-device-v2.pdf?sfvrsn=10.


5. McDonough, C. (2019). Medical devices regulation countdown. [Online]. 2019. Available from: http://www.pharmatimes.com/web_exclusives/medical_devices_regulation_countdown_1277912.


6. Wheeler, M. (2018). Classification Of Medical Devices Under The Eu Mdr. [Online]. 2018. Available from: https://emmainternational.com/classification-of-medical-devices-under-the-eu-mdr/.

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