EU recognition of certificates, remote audits and approvals in the interest of health: how certification of medical devices goes in a global pandemic
In February-March international passenger traffic was stopped in most countries and audits of medical devices manufacturers halted accordingly. But overcoming the pandemic requires meeting the demand for vital medical devices. How to conduct a new certification or annual surveillance in global self-isolation? What new opportunities are opening up and what should we prepare for? We share with you our analysis of events and trends in Ukraine and the world.
In early February, most countries closed passenger flights with China, and arriving passengers were placed in a two-week quarantine. However, outbreaks in other countries followed in the coming weeks, and by mid-March the whole world had closed its borders.
Despite an acute shortage of medical devices to combat COVID-19, such as ventilators and their consumables, infusion systems, X-rays and ultrasound machines, the certification system of many countries was blocked due to the inability to conduct audits. In addition to the impossibility of audits of new manufacturers, scheduled surveillance inspections, which under normal conditions should take place every 12 calendar months, are also at risk.
Recognition of EC certificates
The partial recognition procedure approved by the Article 45 of the Law of Ukraine "On Technical Regulations and Conformity Assessment" has made a significant contribution to cover the demand for medical devices. That procedure allowed many manufacturers to promptly carry out new certifications, expand the scope of existing certificates with new products and perform scheduled surveillance since the beginning of the year.
At the beginning of the year the Ministry for Development of Economy, Trade and Agriculture of Ukraine, in the section "International cooperation" of it’s website, published information about concluded agreements (contracts) on the recognition of the results of conformity assessment between the Ukrainian designated conformity assessment bodies and EU notified bodies.
Despite the fact that the summary contains data only about 15 Ukrainian bodies, the document on 107 pages provides the list of 110 valid Agreements on recognition with 98 notified bodies from 27 countries of European Union. Recognition agreements cover not only medical devices, but also a large number of other areas of technical regulation.
According to the data of the information system NANDO (New Approach Notified and Designated Organisations), 56 bodies are notified for MD Directive 93/42/EEC. According to our information, as of May 20, 2020 the Ukrainian conformity assessment bodies have signed Recognition Agreements with 30 bodies from the list.
In early May Association "Operators of Medical Devices Market" (http://amomd.com/ua/) received a detailed reply from the Ministry for Development of Economy, Trade and Agriculture of Ukraine regarding some aspects of the EU certificate recognition procedure in Ukraine. In particular, the regulator described two equivalent methods of recognition, determined the possibility of unilateral recognition, confirmed the same level of compliance with the requirements of the Ukrainian Technical Regulations and the European directives on which the regulations are based.
The recognition procedure allows medical devices that have been certified in the EU to avoid audits of the manufacturer and production sites, which are the most costly and organizationally complex part of conformity assessment. At the same time, the Ukrainian conformity assessment body should perform a part of the work, including the assessment of all national legal, organizational, technical and language requirements.
The COVID-19 pandemic has led to significant changes in working methods. Quarantine measures (restriction of international and intercity traffic) in a number of countries have shown that there can be no compromise in maintaining business processes and ensuring security of employees without reviewing common approaches and finding new solutions.
Now the lockdown step-by-step trends to end in many countries, however that depends on the overall epidemiological situation and does not allow to build long-lasting plans for resumption of the work in the pre quarantine mode. Thus, restrictions on movement to the EU from third countries have been rescheduled three times and are currently limited to the EU Zone+ on 15 June 2020, but the EU Commission suggests that further rescheduling is also possible. Similar forecasts are expected in a number of other countries: Japan will suspend visas until the end of May with a possible extension, China plans to strengthen control of arriving passengers with different methods of control in each province, and the United States and Canada insist on travel restrictions.
Quarantine restrictions have strongly influenced medical devices certification processes.
Thus, on the basis of the Medical Device Single Audit Program (MDSAP), which allows to assess the compliance with the requirements of the countries participating in the program (Australia, Brazil, Canada, Japan and the U.S.) at the beginning of the year, a pilot project of remote audits was developed with the subsequent temporary introduction of provisions due to restrictive measures and the spread of coronavirus infection for supervisory audits and re-certification. The documents contain a number of recommendations and requirements for alternative audit methods and additionally take into account IAF ID3:2011 and IAF MD4:2018.
A number of changes have taken place in another global market, the EU. Earlier, the Council and the Parliament of the EU supported the proposal of the EU Commission to postpone the date of mandatory implementation of MDR due to the situation with quarantine restrictions and possible losses in the market of medical devices, providing the manufacturer with an additional year to prepare for the new regulation. Another important step is the extension of the notification (designation) of notified bodies to work under Directives 93/42/EEC and 90/385/EEC. This decision is related to the need to avoid a shortage of vital medical devices under the conditions of the granted transition period for the use of MDR, which may arise due to the lack of designated bodies for work with the Directives. Thus, notified bodies, whose notification to the Directives expired in May 2020, will be able to continue work on the maintenance and certification of products to the requirements of the Directives until the mandatory application of MDR in May 2021.
Also in early April the Commission's website published a recommendation on temporary emergency measures related to audits under quarantine restrictions. Among the proposed measures are: remote audits, postponement of audits to the maximum period determined by the body's procedures, taking into account the results of other audits (for example, under the MDSAP program), compliance with IAF standards.
It should be noted that alternative solutions in support of certification of products evaluated through the audit of quality management system with the necessary field visit to production, were listed in the statement of the International Accreditation Forum (IAF), which among the preventive measures defined options for remote audits and postponement of audit dates.
The National Accreditation Agency of Ukraine (NAAU), as an associated member of the IAF, supported the possibility of conducting remote audits during quarantine in Ukraine. International documents ISO/IEC 17011:2017, IAF ID 12:2015, IAF MD 4:2018 were adopted as a basis for remote audits.
Earlier we reported that some conformity assessment bodies have developed and implemented a remote audit procedure. Testing this approach, among a number of obvious advantages in a crisis situation, has shown significant limitations: the initial certification audit requires access to production facilities, but video streaming of such areas for many manufacturers is not acceptable from the confidentiality point of view.
Thus, remote audits mainly help to ensure the maintenance of certification (supervisory audits and recertification).
Permission to enter into circulation in the interest of health
We previously reported on the adoption in March of a package of "COVID" laws aimed at preventing the emergence and spread, localization and elimination of outbreaks and epidemics of coronavirus pandemics in Ukraine. Resolution of the Cabinet of Ministers of Ukraine No. 226 "On Amendments to Certain Resolutions of the Cabinet of Ministers of Ukraine" introduces a procedure for receiving notification (permission) on placing on the marker of certain personal protective equipment and medical devices in the interests of the healthcare system.
In early April, Resolution of the Cabinet of Ministers of Ukraine No. 271 adopted amendments to the list of medical devices and personal protective equipment, including changing the name of the section with the list of personal protective equipment and medical devices, namely, deleting the wording "for health institutions providing care to patients with COVID-19". This made it possible to apply for notification from the Ministry of Health and the State Labor Service without confirming that the products are intended solely for health care institutions.
The notice of introduction is temporary and is limited to either the last calendar day of the month in which quarantine ends or June 30, 2020.
Notwithstanding the mechanism for receiving notification in the interest of the healthcare system described above, mandatory certification has been introduced for the quarantine period for products intended to be worn and/or protected by the user against one or more types of danger to life or health, including disposable medical masks and medical gowns.
Under quarantine conditions, this requirement has raised many questions from market operators - the requirement is very vague, information about certificates of this kind is not specified in industry technical regulations, as well as information about who can issue such certificates.
Conformity assessment procedures without audits
For medical devices with the lowest class of potential risk, which include non-sterile class I and in vitro diagnostic medical devices from group "others", the conformity assessment procedure does not require the audit of the manufacturer. However, registration (notification) with the competent authority - the State Service of Ukraine on Medicinal Products and Drug Control is required.
Earlier the State Service of Ukraine on Medicinal Products and Drug Control informed about changes in the mode of operation for the period of quarantine and, as a result, about possible extension of the period of assessment of paper documents. According to our information, as of today the work on entering data into the register is carried out in a standard mode, without delays.
Thus, the system of technical regulation of medical devices underwent a number of changes in a short period of time, which allowed to avoid shortages or delays in the entry of key medical devices to the Ukrainian market, to reduce the pressure on national health authorities and manufacturers of medical devices, and allowed to prioritise to the efforts against coronavirus pandemic.
Cratia offers professional services on conformity assessment of medical devices. Under quarantine conditions, most of our employees have been transferred to remote work and continue to perform absolutely all current tasks within the standard working schedule. We have an excellent knowledge of national and international legislation, promptly respond to changes and keep with the trends.
We will be happy to assist you!