In overview-European Medical Device Regulation
The medical device regulation journal (MDR 2017/475 and 2017/476) was published on the 5th of May 2017. In its pages are detailed, tremendous changes to the current regulatory structures of the European market. This upcoming device regulation will be on the application, repeal the current medical device directive 93/43/EEC and directive for active implantable medical devices 90/745/EEC. Its aim is to transform the insecure, predictable and unsustainable method with which the manufacturers and distributors handle medical devices, into something that openly reflects an excellent decision-making process and changes to evidently, low quality standards.
Under these new directives, provisions are made to ensure the safety of patients regarding the use of medical devices such as in vitro implantation devices, silicone breast implants and so on. This will go a long way in establishing the damaged bridge of trust between medical devices and consumers -medical personnel and patients.
8 Notable changes to European Union Medical Device Regulations
- A sizeable number in vitro diagnostic medical devices, will be examined by a Notiﬁed Body, before distribution.
- A committee of independent professionals at the EU stage will be in charge of regulating devices likely to be hazardous such as breast implants.
- Experiments on devices located in more than one EU State will be under only one evaluation.
- Many beauty products will be counted amongst medical devices and placed under tighter regulations.
- To foster transparency, EU database consists of complete information on medical devices, most of which will be made widely accessible.
- Monetary insurance guarantees that patients are remunerated if medical devices cause harm to them.
- With an uncomplicated and comprehensive set up, manufacturers can register their products in one swoop at the EU level.
- An implant card for implanted devices is created for the informational value it gives to the patient.
The importance of the new European Union Medical Device Regulations
The new MDR created, is largely beneficial about how it helps to correct and avoid complications that the current directive incurs. It is set to make sure that those problems do not reoccur. Additionally, it establishes the strength of security of all Medical devices in the EU. Besides, the amendment of the legislation was important for the solidification of the position of the EU as a world leader in that division, for the long haul and to pull together, all of the sector’s necessary information regarding scientific and technological growth.
The new regulations will:
- Guarantee a continually immense standard of safety, protection, and health for EU residents using these devices.
- Ensure that the notable scientific developments occurring in this industry over two decades ago, will be in conformity with the EU directives.
Switch over dates and period
With the publishing of the significant changes in medical device regulations in the Official Journal (May 5th, 2017), the switch over date is kicked off. Means, the application cycle commenced officially on the 25th of May 2017. Producers of digital health devices will be allowed no more than three years (deadline is on the 25th of May 2020) to adhere to the Medical Device Regulations (MDR). However, the manufacturers of the in vitro diagnostic devices will be allowed a transition period of five years (ends on the 25th of May 2022).
Medical device producers are firmly commended to kick start the implementation of the MDR new regulations soon in order to safeguard the EU acquiescence for their medical devices, given the many changes in the regulatory compliance procedure, particularly for the hazard prone devices.
The effects of the MDR on digital health companies
Over four hundred European Union residents are employed in more than twenty thousand Digital health companies. This cements the industry’s position as a major job provider in Europe and the world.
Small and medium-sized businesses (SMEs) are the wheels, which propel this sector of industry, forward. Therefore, the upcoming Regulations will assist the European Union industry to not only expand but also maintain its leadership status on the global scope; a more solid and competitive force in the intricate global scene. The principal elements that will bring about the influence aforementioned are;
- Heightened Legal Certitude – Positive competition and development are founded on the presence of a steady combination of legal conditions. Unlike a Directive, a Regulation is exactly appropriated to the EU: This action prevents complications for patients and industry in various nations. The Regulations incorporates comprehensive and definite modifications that clarify the coverage area of these new rules, an enumeration of concise duties of important economic operatives and pinpoint particular exclusion procedures concerning certain medical devices or systems.
- Enhanced Repute and Validity of the Entire Organization – The current state of the digital health sector is somewhat shaky. Their reputation is a sensitive matter in regards to the validity of the entire European Union medical device system. This is as a result of several mishaps and widespread reports on professed discrepant methods among the bodies in charge of the approval of medical devices; A damage of trust between medical personnel, patients, and these supposedly safe devices, they use every day, confirms the invalidity in the current legislation. With these upcoming Regulations, the shortcomings of the current legislation will be corrected thereby resulting in an enhanced confidence in the medical device industry.
- A Streamlined Organization process – With the latest structure, registering operatives and devices will have to be done in one swoop at the European Union level. This is a massive transformation that has a gaping contrast to the current circumstances where in many cases, there is a demand for the producers to register their products in the EU states where they are distributed.
These benefits should be able to offset the added expenses business acquire due to compliance with the higher safety standards and new requirements contained in the new Regulations. Particular requirements for small and medium businesses has been confronted in the journal, particularly in relation to the pre-requisite on financial insurance for manufacturers, persons held accountable for regulatory compliance and, fees charged by Notified Bodies; a potential boost to SMEs active in this sector.
How Digital health businesses can prepare for the new regulations
The latest MDR symbolizes an important transformation in the regulatory sphere so it is imperative that all producers arrange and develop a clear plan that will ensure compliance.
However, most of this sector’s experts expect weighty challenges to rolling in with the regulation’s revisions. To come out on top and, avoid being overrun during the new MDR enforcement; it is imperative for manufacturers to take charge and take very logical steps in evaluating their current practices to ensure that a clear-cut plan is organized.
MDR’s goal is to bring about a crystal clear, foreseeable, sturdy and endurable regulatory structure for medical devices, which will not only mean ultimate security within the healthcare sector, but will also propel manufacturing companies forward in the race towards innovation.
Given that both new and existing devices on the market have to be entered into the new setup, complete compliance with the MDR’s recent stipulations might be a complex and lengthy process.
In addition, extra managerial baggage will be placed on manufacturers, with external expense budgets and recruitment processes, which need to be adequately supervised.
5 important tips for your digital health startup
- Solid, unwavering coordination and accurate prediction of administrative hitches are qualities to maintain. Be alert for any indication of sudden bumps in administrative and executive actions.
- Top executives should take charge because there is a need for the Medical device producers to continually evaluate the situation and carry out detailed gap analysis on these devices and the entire company in light of the new MDR stipulations.
- Scrutinise the competency of the Quality Management System (QMS) course of action and method of progression into ISO 13485:2016.
- It is critically important, that you have a knowledge of all non-compliance risks. Be certain, that the administration grasps the significance of the new MDR and the potential repercussions. To achieve this, multi-functional groups should be set up for inclusive responsibility for MDR execution and placed in charge of all, or some, parts of it.
- With the build-up of extra burden on the Notified Bodies and their space, it is essential that there are back and forth interactions. This is to ensure that they possess an opportunity to assist in executing any plan.
These tips will hopefully help guide your digital health business in the right direction of complete compliance with the new MDR rules so that any or every form of unnecessary risks and consequences will be avoided.
Other good sources of information & references
Anon., 2017. European Commission. [Online]
Available at: https://ec.europa.eu/growth/sectors/medical-devices/regulatory-framework_en
[Accessed 09 September 2017].
Anon., n.d. HPCI. [Online]
Available at: https://www.hpcimedia.com/enews/Building-Better-Healthcare/
[Accessed 09 September 2017].
Brooks, P., 2017. 6 Things You Need to Do to Prepare for the New EU Medical Devices Regulation, Europe: RF Regulatory Focus.
Buttron, S., 2017. NAMSA. [Online]
Available at: https://www.namsa.com/european-market/eu-mdr-poses-significant-changes-for-importers-distributors/
[Accessed 09 September 2017].
Rose, P., 2017. BBH. [Online]
Available at: https://www.buildingbetterhealthcare.co.uk/news/article_page/10_top_tips_to_conform_with_the_new_Medical_Device_Regulation/131638
[Accessed 09 September 2017].