Quality by DesignDecember 6, 2022
Does your QMS work for YOU or do YOU work the QMSMarch 2, 2023
Simone Rudolph-Shortt 19th Jan 2023
|Medical Device Class
|Class III implantable custom-made devices
|May 26, 2026
|Remaining class III devices Class IIb implantable devices (exceptions exist)
|December 31, 2027
|Remaining class IIb devices Class IIa devices Devices of classes Is and Im
|December 31, 2028
|Remaining class I devices for which a notified body must be involved under the MDR (e.g. class Ir devices)
|December 31, 2028
|Remaining class I devices
|May 26, 2021 (as before)
The MDR will replaced the existing medical devices Directive (93/42/EEC) (MDD) and the active implantable medical devices Directive (90/385/EEC) (AIMDD). The MDR was published in May 2017, marking the start of a four year period of transition from the MDD and the AIMDD.
We, the WORLD, need a dedicated GLOBAL Health Products Regulator [GHPR], for ALL health Products i.e. medical devices, medicines, OTC products, complimentary products, health supplements, Disinfectants, PPE, established at the WORLD HEALTH ORGANISATION [WHO], represented by all the countries of the world with;
- a single regulatory assessment approval process
- using shared country product experts
- with a single cost and time line
for a global safety and performance assessment certification. Each Country can then provide a market access process and fee, with part of the fee contributing to the single shared GHPR (alike the ISO establishment with standards and management system development and implementation https://www.iso.org/about-us.html ).
WHAT IS THE REAL PROBLEM?
For the EU, and UKCA, Notified bodies are the problem and doing an extension is not going to solve the problem. Other mature jurisdictions like FDA, TGA, Health Canada do not have a problem in that they have inhouse regulatory management however they too have forward regulatory risks ;
- Insufficient number and qualified technical experts
- Bodies with limited Product knowledge and expertise as the new technologies product expertise which sits with the innovator, manufacturer or producer and not a regulator
And then manufacturers have the following risks that could end products being placed on the market, such as;
- regulatory cost constraints due to multiple country registrations where the same technical evidence is reviewed by numerous assessors around the world
- time and access to markets due to numerous jurisdictions having replicate regulatory oversight
- the deciding or unable to enter or export market access resulting in some populations not having access to safe and performing products
What does this mean to us, the people (and our animals)?
Everyone is focused on safety and performance regulatory obligations, but no one addresses peoples statutory right to have access and affordability to safe and performing health products and care.
Around the world each country has or is building its own regulatory establishments (corporations) adding additional costs to the price of healthcare products that universal health coverage can not afford. Universal health coverage [UHC] means that all people have access to the health services they need, when and where they need them, without financial hardship. It includes the full range of essential health services, from health promotion to prevention, treatment, rehabilitation, and palliative care. Some countries have sufficient resources and maturity to validate a resident regulatory authority however many countries, now in the process of establishing a local regulatory authority will ultimately burden their population with cost and time constraints even to the extent of import manufacturers deciding not to access these markets.
These multiple, replicated and duplicated regulatory requirements of each country increase cost and time delays to a market that is price and globally volume constrained to the increased world population making access to the rich few and a barrier to many; especially as we also have mature jurisdictions such as USA, EU versus and immature jurisdictions African countries respectively.
A dedicated GLOBAL Health Products Regulator [GHPR], for ALL health Products would reduce country specific and household insurance or tax premiums, and decrease out-of-pocket (OOP) health care costs to both people and governments. Administrative expenses in the health care sector would decline, freeing up productive resources for other sectors and ultimately increasing economy wide productivity.
WORLD HEALTH ORGANISATION
WHO is s responsible for providing leadership on global health matters, shaping the health research agenda, setting norms and standards, articulating evidence-based policy options, providing technical support to countries and monitoring and assessing health trends. In the 21st century, health is a shared responsibility, involving equitable access to essential care and collective defense against transnational threats. https://www.un.org/youthenvoy/2013/09/who-world-health-organisation/.
The issue of notified bodies being under-resourced is known among the industry. The last survey of the Association of British Healthcare Industries clearly shows the concerns of the manufacturers in the shortcoming of the notified bodies. The outcome of the ABHI survey was that 91% of respondents said that their applications had not been compromised due to the lack of notified body capacity; 50% of respondents said their certificate renewal was delayed by their notified body; and 32% stated that their notified body missed or seriously postponed a scheduled audit or product assessment. In TEAM-NB’s, the European Association for Medical devices of Notified Bodies, view, there is a number of reasons for the delays and inability of notified bodies to conduct their audits in a timely manner, as highlighted in the survey. These include, among others, the new recommendations and requirements for notified bodies, including the introduction of unannounced audits. Additionally, some of the notified bodies didn’t pass the mandatory re-designation audits which means they are no longer accredited for the certification. According to the Team-NB, the lack of resources is well known to the European Commission and the competent authorities and is expected to be a topic in the current discussions in Brussel. https://www.med-cert.com/eu-notified-bodies-resources-problems/
Notified bodies have yet to issue Medical Device Regulation certificates for more than 85% of the products previously certified under the old directives, according to an industry survey. The survey of MedTech Europe members suggests the vast majority of the more than 500,000 devices certified under the old directives have yet to be converted to MDR. The survey indicates that some of the devices likely will never get MDR certificates as 54% of the respondents plan portfolio reductions. Notified body capacity may remain an issue despite the withdrawals. MDR certification is taking 13 to 18 months, meaning companies need to start the process soon to meet the May 2024 deadline, and 30% of smaller businesses lack access to MDR-designated notified bodies, the poll found. https://www.medtechdive.com/news/legacy-devices-lack-mdr-certificates-medtech-europe/627439/
We are in year 2022 and Health Products have evolved from before the 1900s, where product regulatory oversight started, with doctors, nurses using basic cloth bandages, scalpels, sutures and surgery. Regulatory oversight was non-existent in the past and now we have specialist healthcare practitioners like radiologists, orthopaedic surgeons, cardiologists applying high technology non invasive or new technology surgeries using sophisticated items like implants, endoscopes, arthroplasty, etc.
The Food and Drug Administration (FDA) is the oldest comprehensive consumer protection agency in the United States. The FDA’s oversight of food and drugs began in 1906 when President Theodore Roosevelt signed the Pure Food and Drugs Act. Since then, Congress has expanded the FDA’s role in protecting and promoting the development of human and veterinary drugs, biological products, medical devices and radiation-emitting products, human and animal food, and cosmetics. In the 1960s and 1970s, Congress responded to the public’s desire for more oversight over medical devices by passing the Medical Device Amendments to the Federal Food, Drug, and Cosmetic Act. In 1982, the organizational units at the FDA that regulated medical devices and radiation-emitting products merged to form the Center for Devices and Radiological Health (CDRH). https://www.fda.gov/medical-devices/overview-device-regulation/history-medical-device-regulation-oversight-united-states
Medicines and medical devices have been in existence for centuries. According to the literature, there is evidence that scalpels, slings, splints, crutches and other medical devices were used as long ago as 7000 BCE by the Egyptians. Neither drugs nor medical devices are ordinary consumer products. In most instances, consumers are not in a position to make decisions about when to use them, which to use, how to use them and how to weigh potential benefits against risks as no medicine or device is completely safe. While the concept of ensuring their quality has evolved gradually over time, the modern health products regulation started only after breakthrough progress in the nineteenth century, especially in chemistry, physiology and pharmacology. Historically, countries have tended to introduce regulation or tighten existing regulation only when forced to do so by a public outcry over an unexpected and unfortunate event. First and foremost, concerns raised over adulterated foods triggered the creation of the Federal Drug Authority (hereinafter ‘FDA’) in 1906. Although it was not known by its present name until 1930, FDA’s modern regulatory functions began with the approval of the 1906 Pure Food and Drugs Act, a law that prohibited interstate commerce in adulterated and misbranded food and drugs. In 1937, the death of over 100 Americans who had taken a cough mixture containing an antifreeze-type chemical facilitated the introduction of pre-market testing to their medicinal regulatory requirements. Later, in the 1960s, with the thalidomide incident, a tranquilliser and sleeping pills that caused phocomelia in newly born children as a side effect, the international community has shared consensus that drug, medical technologies and products used in patient care must be subject to stricter regulation than other consumer goods. In fact, however, regulation for medical devices started relatively late, triggered mainly by a major public concern in the 1960s and 1970s regarding the risk of micro-shock from an electrical current via devices connected to patients.3 During the 1970s and 1980s, demand for stronger regulatory legislation arose from serious effects caused by intrauterine contraceptive devices (the Dalkon shield and the Copper-7 device) and several brands of tampons. Beginning in the 1970s, countries with a strong medical device industry initiated the process of either developing or strengthening their regulatory systems. While in most countries around the world the need for regulation arose primarily to enable patients’ access to high-quality, safe and effective medical devices, and avoid access to products that are unsafe, in Europe the regulatory environment became more stringent mainly to enhance the cohesion of the Single Internal European Market. Indeed, with the signature of the Treaty of Rome in 1957 (hereinafter ‘EC’ Treaty) a Single Market for the European Union was created, with the aim of, among others, removing barriers to trade within the European Community (EU) Member States. In line with such an objective, Article 30 of the EC Treaty forbids ‘qualitative restrictions on imports and all measures having equivalent effect between Member States’, although derogations are allowed, based, inter alia, on grounds of protection of health and life of humans, animals or plants. Therefore, this can only confirm Altenstetter’s arguments: in Europe, regulation of the medical device sector in a harmonised manner would not only ensure patients’ access to high-quality, safe and effective medical devices but would also contribute to the smooth functioning of the internal European market, enhancing competitiveness of the Eurozone. https://www.elevenjournals.com/tijdschrift/ELR/2019/2/ELR-D-19-00012