Ranging from every easy sticking plasters, contact lenses to sophisticated pacemakers and hip replacements, cardiac stents clinical devices and in vitro diagnostic medical devices are vital to our health to improve our quality of life. People depend upon these devices every day and expect them to be secure and contain the ultra-modern progress in science and innovation.
The Commission has followed numerous implementing measures based totally on the Medical Devices Directives.
Council Directive 90/385/EEC on Active Implantable Medical Devices (AIMDD) (1990)
Council Directive 93/42/EEC on Medical Devices (MDD) (1993)
Council Directive 98/79/EC on In Vitro Diagnostic Medical Devices (IVDMD) (1998)
A European Union carried out a New Approach called “Medical Device Directives” for Medical Device to ensuring the safety and performance for the patient or intended user in early 1990’s. The European Regulations on Medical Devices is Medical device directives (MDD) regulates the safety and marketing of medical devices in Europe. This new approach must follow by the medical device manufacturer to vending their product on the European Market and the manufacturer must met these directives.
The European Union (EU) follows a four-class scheme. Medical Devices are categorized into Class I, Class IIa, Class IIb, and Class III that shown in Figure 1.
European Regulation on Medical Device Directives have some basic target and principles.
The Main and necessary requirements is Annex I which gives an outline for the mandatory precautions and requirements to be considered for manufacturing a medical device as well as disposal medical devices.
Notified Bodies will assess the level of risk based on the Classification of Medical Devices and proceed with the Conformity Assessment.
Monitoring and Vigilance.
On 5th April 2017 European Union carried out a new Regulations on Medical Devices and In-vitro Diagnostic Medical Devices to modernized and more robust legislative framework to ensure a better protection of public health and patient safety. This new Regulations is begin into force on 25th May 2017 and it will progressively put back the existing directives after a particular transition period.
Regulation (EU) 2017/745 is a regulation of the European Union on the medical device, clinical investigation & evaluation and sale of medical devices for human use. It revoke Directive 93/42/EEC, which concerns medical devices, and Directive 90/385/EEC, which concerns active implantable medical devices. The Regulation was published on 5th May 2017 and came into the force on 27th May 2017. Medical devices have a transition time of 3years which has been originally approved to meet the new requirement.
The new EU Regulations aims to create a new and improved landscape for the medical devices industry, with some new guidelines.
All the Medical Devices will undergo an independent assessment of safety and performance before they can be marketed in the European Union.
This new EU Regulation will have be greater transparency of information on the benefits for the patients, residual risk, and thorough assessment of the overall risk/benefit ratio will be assessed.
There will be greater and clearer rules to enable standardization and support simpler and less complex trading between European Union Member states, those do not comply their statement they will be penalized.
The new EU rules support patient-orient innovations and taken a specific need in a particular account of the many small and medium sized manufacturer.
The European Union Medical Device Regulation (EU MDR) will have a further responsibilities on “Notified Bodies” those independent third parties performs a conformity assessment for medium and high risk devices. The Notified Bodies will be subject to intense examination from competent authorities and will need to be designated under EU MDR, with the process of designation co-ordination at a European level.
HOW DOES ISO 13485 HELP WITH MDR COMPLIANCE?
WHAT IS ISO 13485?
ISO 13485 is an independent Quality management system (QMS) standard, and it is internationally recognized and acknowledged with ISO 9000 quality management standard series. ISO 13485 adjusts the ISO 9000 process-based model to direct a medical device manufacturing environment. While ISO 13485 depends on the ISO 9001 process model concepts of Plan, Do, Check, Act, it is intended for regulatory compliance. It is more prescriptive in nature and requires a more recorded documents for quality management system.
ISO 13485 document is helps to support the medical device manufacturer in planning the quality management systems later they will establish and maintain the adequacy of their process cycles. It ensures the predictable design, development, production, installation, and delivery of medical devices that are safe for their intended purpose.
Where ISO 13485 comes in MDR??
ISO 13485 in MDR comes in Design and Development phase of medical device: The new Medical Device Regulation (MDR, EU 2017/745) has presented several new and essential process updates that should be incorporated in a manufacturing process 'Quality Management System (QMS) of current or intend plan to sell medical devices in the EU. These processes go beyond from the current requirements for ISO 13485:2016 and the Medical Device Single Audit Program (MDSAP). The basic for the new QMS requirements is set down in Article 10 (General obligations of manufacturers) and Chapter 1: Quality Management System of ANNEX IX of the MDR. Notwithstanding, additional QMS requirements are dispersed all through the MDR articles and annexes. The MDR presents a additional requirement that go beyond the Article 10, ISO 13485:2016 and the MDSAP. These requirement should be completely explored to understand their relationship and impacts on key QMS measures. A typical design and development measure cycle incorporates various successive design stages or phases as set down by ISO 13485 or 21 CFR 820.30. These phases ordinarily incorporate Design and Development Planning, Inputs, Outputs, Verification and Validation, Commercialization, Post-Market and Design Changes. The MDR does not need any progressions to the current design control structure as to having stages or phases. Nonetheless, it is normal that the amended requirements in the MDR will be incorporated in the design control cycle started during the planning and carried throughout the design cycle, including the post market phase.
Unique Device Identification (UDI): Verifying a medical device product through the UDI Framework, including a commitment to place a significant data on the label of the device and all higher levels of packaging. What's more, UDI device identifiers (UDI-DIs) should show up on the EU Declaration of Conformity. The European UDI System has been planned to improve the traceability of medical devices also, IVDs, and to improve the incident reporting and oversight by the competent authorities. UDI will be utilized the report for serious incidents and field safety corrective action activities. MEDDEV layouts have been developed and that will incorporate a numeric descriptions and UDI, with the assignment of keeping the list of UDI’s exceptional being the obligation of the manufacturer.
EUDAMED: The European database on medical devices will be transformed the data into a public instrument. Previously, EUDAMED has been an information repository exclusively accessible to national competent specialists and the European Commission. The new MDR is presently ordering the utilization of this web based gateway for economic operators and notified bodies to provide the information related with different articles of the MDR, including clinical investigations and summaries of safety and performance for class III and implantable devices. The database is required to be operational in May 2020, but delays may occur.
Post-Marketing Surveillance (PMS): Post-Marketing Surveillance (PMS), otherwise called post market surveillance, is the act of monitoring the safety of a pharmaceutical drug or medical device after it has been delivered available on the market and is a significant part of the science of pharmacovigilance. The MDR clarifies for the first time that the post market surveillance of medical device they gave a set of regulation and its definition under article 2 and article 10 records the obligations of a manufacturer. These include it will focused on section 9: manufacturers of devices shall establish, document, implement, maintain, keep up to date and continually improve a quality management system that shall guarantee the compliance in the most effective way and that is proportionate to identify the risk class and the type of the device. The quality management system concerns several aspects, and specifically the setting-up, usage and support of a post-market surveillance framework, for every device. This aspect is significant because surveillance becomes explicitly and compulsorily a fundamental part of the quality management system and the relevant documentation is essential for the technical documentation.
MDR during pandemic: Medical Device Regulation (EU) 2017/745 altogether reinforcing the key components of the current regulatory approach in Council Directives 90/385/EEC and 93/42/EEC for example, the supervision of notified bodies, conformity assessment procedure, clinical examinations and clinical assessment, vigilance and market surveillance, while presenting the provisions ensure that transparency and traceability with respect to medical devices, to improve the health & safety protection measures. During the COVID-19 outbreak and related to the general public health crisis presents a remarkable challenge to the Member States and establishes an immense burden for the national authorities, health & safety organizations, Union citizens, and economic administrators. The public health crisis has created remarkable conditions that demand a generous additional resources, as well as an expanded accessibility of imperatively significant medical devices, that could not be sensible at the time of adoption of Regulation (EU) 2017/745. Those remarkable conditions have a critical effect on different territories covered by Regulation (EU) 2017/745, for example, the assignment and work of the notified bodies and the putting available on the market and making accessible and available of medical device in the Union.
Medical devices, for example, clinical gloves, surgical masks, equipment for intensive care and other clinical equipment, assume a pivotal part with regards to the COVID-19 outbreak and the related to the public health crisis to guarantee the health and safety protection of the Union citizens and to empower the Member States to give fundamental clinical treatment to patients who are urgently needed such treatment. Given the extraordinary magnitude of the current difficulties, and considering the unpredictability of Regulation (EU) 2017/745, Member States, health institute, economic administrators and other relevant parties will not be in a situation to guarantee the appropriate implementation and utilization of that Regulation from 26 May 2020 as set down in that. To guarantee the smooth functioning of the internal market, a significant level of protection of public health and patient safety, to give legitimate certainty and to avoid potential market interruption, it is important to the utilization of specific provisions of Regulation (EU) 2017/745. Considering the COVID-19 outbreak and the related general public health crisis, its epidemiological development, and the additional resources needed by the member States, health institute, economic administrators and other relevant parties, it is suitable to defer the utilization of those provisions of Regulation (EU) 2017/745 by one year.
Author:
Geetha Balasubramani
Lead-Operations
MedCuore Medical Solution Private Limited
References:
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 (OJ L 189, 20.7.1990, p. 17).
Council Directive 93/42/EEC of 14 June 1993 concerning medical devices (OJ L 169, 12.7.1993, p. 1).
Deliverska M. Chapter: Border cases and classification in Union’s regulatory framework in medical devices – short review of some dental products. In: Biocompatibility in oral medicine. From Theory to Practice. Publisher: Medinform 2016.
Deliverska M. Chapter: European and international standards on medical devices in dental medicine. In: Biocompatibility in oral medicine. From Theory to Practice. Publisher: Medinform 2016.