What can medtech expect for the rest of 2020 and into 2021, in these unprecedented times? Medtech Insight explores.
What can medtech expect for the rest of 2020 and into the first half of 2021, in these unprecedented times? Medtech Insight explores.
During the first nine months of 2020, politics and pandemic panic heavily influenced the regulatory momentum of the medtech sector. Companies flexible enough and with sufficient resources to adapt to the changing demands and landscape are most likely to weather these storms.
But we are constantly warned that not all will. Many feel battered by constant change and are unprepared. That is especially the case among SMEs, which make up 90-95% of medtech companies.
So where are we now? And how can industry best prepare for eight months until 26 May 2021, the date of full application of the EU Medical Device Regulation (MDR)?
Firstly, it is worth remembering that up until late April this year, the medtech sector was expecting the MDR to fully apply by 26 May 2020.
If that had happened, many in the sector would have experienced problems, some companies even failing to be compliant in time because of the lack of guidance and notified body capacity, and due to the ongoing absence of fundamental elements of the infrastructure, such as the Eudamed medical device database and standards.
The one-year delay to the full application date of the MDR to 26 May 2021 mean the problems foreseen have been averted – for now.
But the big question is whether these problems will be solved by the one-year delay, or whether they will they resurface again next May, when the deadline hits.
The implementation of the MDR and IVDR were always going to be multi-layered and complex. But the COVID-19 pandemic, in addition to the upheaval caused by Brexit and Swixit, are making it even more so. There are many regulatory balls that industry needs to juggle while keeping an eye on unexpected developments. This article aims to summarize how recent events have impacted the outlook for successful compliance with the new regulations on time, and to speculate how they are likely to shape the nine months remaining before the MDR’s full application.
Topics covered are: MDR Delay; Virtual Audit Solution; Virtual MDR Initial Audits; Critical Documents and Planning – Guidance, Implementing Acts; More Documents To Come; The IVDR; Notified Body Developments; Standards Request Rejected; The Eudamed Medical Device Database Delayed; Expert Panels; Persons Responsible for Regulatory Compliance (PRRC) Challenges; Brexit, Swixit and Turkey.
A delay in the full application of the MDR was something industry had long lobbied for. The European industry association, Medtech Europe, was convinced that the sector was not sufficiently ready in the early part of 2020. And it was not alone; even representatives of EU competent authorities and the US Food and Drug Administration had been adding their voice to the plea for extra time. All feared that products essential for health care would have to be pulled from the market on 26 May 2020.
But the European Commission was not convinced by this argument; it continued to make plans based around its original 2020 timetable, confident its program of designating notified bodies and posting MDR guidance documentation would be sufficient for successful – even if not fully complete ̶ implementation to take place on time.
It was not until COVID-19 struck and overwhelmed the devices sector that the priorities and ways of working of medtech stakeholders – authorities, notified bodies and manufacturers, as well as the commission itself ̶ had to shift. At this point, the commission conceded to the need for a one-year delay to the MDR, making the new deadline 26 May 2021. (Also see "EU’s MDR One-Year Delay Now Official As Amending Regulation Is Published In EU Official Journal" - Medtech Insight, 24 Apr, 2020.)
But the postponement is not the solution many had wished it would be. This is for many reasons, including:
In other words, it was COVID-19 and its challenges that brought about the MDR’s one-year delay. But the problems around trying to address the coronavirus crisis are also the most likely obstacle to the successful full implementation of the MDR next May too.
The EU seems to be on the brink of a possible second wave as cases start to climb rapidly again in many countries, such as France, Germany and Spain, meaning that physical audits of and by notified bodies will continue to be impacted.
Indeed, for those new products that must comply with the MDR by 26 May 2021 that cannot benefit from the grace period and that need the involvement of a notified body, EU rules require physical audits.
But these are not taking place generally because of COVID-19 social distancing rules and ongoing travel restrictions around the EU.
There are cases where virtual audits are permitted; but this is mainly for products that are already CE-marked under the MDD as well as for emergency products needed to treat patients with COVID-19.
The European Commission’s Medical Devices Coordination Group (MDCG), which supports the commission with implementation, has issued Guidance 2020-4 on permitting surveillance, recertification audits and audits triggered by changes under the existing medical device directives (the active implantable, medical device and IVD directives) virtual. But it does not really address audits under the MDR, many of which are likely to be initial audits.
This means that timely compliance for a whole swathe of innovative and often high-tech devices will depend on how COVID-19 spreads and on social distancing and travel rules; this is particularly the case because it can take nine months to be assessed and receive conformity assessment by a notified body ̶ and there are only nine months left until the MDR fully applies.
For those devices that can benefit from the grace period and whose certificates are up to date or able to be reassessed in time by a notified body under the Medical Devices Directive (MDD), full compliance with the MDR can be delayed up until 2024.
But medical devices that will need to comply by the 26 May 2021 deadline are:
The vast majority of IVDs, which will require the involvement of a notified body for the first time, will also need to have a conformity assessment certificate from a notified body by 26 May 2022, and not be able to benefit from the grace period and the extension until 26 May 2024.
While there are no signs yet of the European Commission extending virtual audits to include initial audits under the MDR, it acknowledges that months of activity have been lost by notified bodies because of COVID-19, so it has put in place a series of measure to monitor device availability to prevent or remedy potential device shortages.
In other words, while the date of application has been delayed for a year, fears over devices suddenly becoming unavailable have not gone away, particularly given the current restrictions on notified body activities caused by the COVID-19 pandemic.
But while the commission is monitoring the situation now and will over coming months, it has not responded to the plea made by industry for MDR virtual audits to be allowed.
This is despite MedTech Europe having issued a position paper stating that the medtech sector will not derive any benefit from the one-year delay because of COVID-19 travel restrictions and social distancing, which have made on-site audits nearly impossible for now.
MedTech Europe says: “This leads to situations where manufacturers who aim to transition to the new regulations as early as possible are currently held back by notified bodies’ assumptions that audits under the MDR/IVDR must be conducted at the manufacturer’s premises, ie on-site…”.
Despite the obstacles for the sector in making productive use of the MDR one-year delay, there is some good news. The pace of guidance being published has really stepped up and many more documents are in the wings and due to be published soon.
There are now some 60 guidance documents on the European Commission’s MDR guidance webpage to support the implementation of the MDR, some of which has already been revised.
This guidance, most of which has been endorsed by the European Commission’s Medical Device Coordination Group, supports the interpretation of the MDR with respect to unique device identification (UDI); the Eudamed medical device database (Eudamed); the European Medical Device Nomenclature (EMDN); notified bodies; clinical investigation and evaluation; new technologies; and other topics.
The European Commission also has a page on its website detailing ongoing guidance development within the MDCG subgroups, which was last updated in July 2020. There are 42 items on this list with estimated dates of when the documents will be endorsed by the MDCG.
While manufacturers and other stakeholders are hungry for guidance to better understand how to comply with the new regulations, far more guidance is being produced than had originally been expected. Indeed, when the MDR and IVDR were first drafted – accompanied by much astonishment at how much more detailed they were than the directives ̶, the authorities argued that existing guidance under the medical device directives had been absorbed into the regulations.
But now the need for guidance to explain the regulations has meant that a huge amount of additional guidance has been written, and much more is still being drafted.
The MDR and IVDR foresaw that some of the regulations would need to be explained in subsequent implementing or delegated acts. Drafting these acts is a lengthy procedure. While there are some 80 acts, 12 have been prioritized as needing to be ready by the time the MDR fully applies.
But the only acts that are ready so far are: the Commission Implementing Regulation on the definition of the list of codes and corresponding types of device for specifying the scope of designation of notified bodies, which was adopted and published on 24 November 2017; the Commission Implementing Decision on the designation of one or more entities to operate the system for the assignment of unique device identifiers, published on 7 June 2019; and the more recent Commission Implementing Regulation on Common Specifications (CSs) for the reprocessing of single use devices (SUDs).
The European Commission’s MDR/IVDR Roadmap gives an overview of all the work that has been planned under the two regulations, along with a high, medium or low priority grading.
In early July this year, competent authority expert Thomas W. Møller explained how work on a third of the implementation tasks remained to be started. “Of the 165 separate items listed, 50 have been completed, while 47 are ongoing and 68 have not even been started yet,” Møller said at that time. He is section manager of medical devices at the Danish Medicines Agency, and newly elected as chair of the executive board of the EU’s CAMD (Competent Authorities for Medical Devices) group.
Having these 165 activities ready for the 26 May 2021 MDR application date is just not tenable, he told Medtech Insight in summer 2020. “We have grouped these remaining activities as ‘necessary, important, or nice to have,’ to create a prioritized list moving forward towards the implementation date,” he said at that time. (Also see "Competent Authorities Warn EU Industry Not To Expect All MDR Implementation Tools In Time" - Medtech Insight, 2 Jul, 2020.)
The late timelines will be particularly tight for the much-needed common specifications, detailed technical requirements, which are being developed, among other products, for medical devices without a medical purpose, known as the Annex XVI products. Annex XVI products include dermal fillers, liposuction equipment, breast implants, skin resurfacing equipment and brain stimulation products.
This means that these products, which are being regulated for the first time at EU level, may struggle to be compliant by 26 May 2021. Many of these products are coming under regulatory control for the first time as they are not regulated nationally, so any delays leave patients exposed to risks that the commission, European Parliament and Council of the EU were keen to avoid by regulating these products under the MDR.
The expected timelines for other much needed documents under the MDR and IVDR is being continually updated in the European Commission’s MDR rolling plan which is available via its website.
The expected publication date of implementing acts with the highest priority are as follows:
Description of Implementing Act
Expected Timelines
Common specifications (CSs) for products without a medical purpose
CSs for groups of products listed in Annex XVI of the MDR, which address application of risk management and, where necessary, clinical evaluation regarding safety. Manufacturers of these products cannot apply for conformity assessment review until these CSs are adopted
Q4 2020
Setting up of expert laboratories
Designation of expert laboratories; the designation of expert laboratories is not mandatory
Q3 2020
CSs for IVD Class D
CSs for IVD Class D in the context of the scrutiny mechanism for high risk devices
Rules for EU reference laboratories (EURL)
Rules to facilitate application of IVDR EURL tasks. Date of application of the act may not be earlier than 25 November 2020, according to the IVDR
Fees for EURL services
Definition of rules for fees for the advice/testing activities performed by EURL. Date of application of the act may not be earlier than 25 November 2020 according to IVDR
EU reference laboratories
Designation of EU reference laboratories. Designation may take place no earlier than 25 November 2020. Nominations are in preparation
Q1 2021
Although medical devices and IVDs are being regulated under the same broad framework, the sectors have their own EU regulation because of the differences in the nature of the products and, therefore, require different approaches.
So, while many of the problems that are besetting the medical device industry which needs to comply with the MDR are also impacting the IVD industry, the IVD industry has its own challenges in ensuring it is compliant by the IVDR full application deadline of 26 May 2022. The scale of these is particularly great and there is growing concern among experts in the industry that the IVD industry is slow to understand the urgency with which it needs to begin compliance activities:
These are the some of the issues the IVD industry is facing:
As there has been a one-year delay to the date of full application of the MDR, the IVD industry is still hopeful that it will benefit from the same kind of delay. It is also lobbying for a greater number of IVDs to be able to benefit from the grace period.
It is encouraged by the recent concession granted by the European Commission to class I upclassified medical devices under the MDR, which were latterly included in the list of products have been able, latterly, to benefit from this grace period in addition to other products already listed in the original regulation.
Readers can expect strong lobbying to continue, in a bid to seek a “stay of execution” for these products.
COVID-19 has had an enormous impact on many manufacturers’ ability to transition to the IVDR according to their original plans and timelines Some companies who were as ready as they could have been at this stage in terms of IVDR compliance have had plans their heavily impacted. This might have been, for example, because audits cannot go ahead with their notified body or because they were expecting their notified body to be designated under the IVDR this year and the timeframes are no longer clear.
Many IVD manufacturers now have clinical studies on pause too, because of COVID-19, and some estimates suggest it could be nine months before they can restart them. This obviously delays when they can file for conformity assessment.
MedTech Europe is also frustrated that the EU chose not to opt for the possibility of pan-European derogations from the need for full conformity assessment procedures for IVDs intended to help in the COVID-19 pandemic as well as for medical devices, within the amending regulation. This means that manufacturers must seek national derogations in every member state where their product is to be marketed and this could cause them to prioritize the bigger markets.
As of mid-August, there were now 20 notified body designations in total, 16 under the MDR and four under the IVDR. These include two designations for BSI UK ̶ under the MDR and the IVDR. BSI is due to lose its designation status on 31 December at the end of the EU/UK Brexit withdrawal period, which means just 18 of the current designations will remain valid from the beginning of next year.
The hope is that there will be more designations in the meantime. But notified bodies cannot even begin testing under the MDR and IVDR before they are designated, so each day of delay could further threaten their ability to finalize the conformity assessment of MDR products before the 26 May 2021 deadline. There are, of course, many other factors that are compromising the likelihood of timely compliance (for example the appointment of expert panels in the case of higher risk products).
The figure of 20 notified bodies under the MDR and IVDR compares with over 80 designations under the Medical Devices Directive at its height (there are 54 now), and 22 under the IVD Directive.
The European Commission had originally promised 20 designations under the MDR and IVDR by the end of 2019. But it has defended its record by stating that the larger notified bodies were among the first designated and therefore there has not been the kind of capacity issue shortfall at notified bodies that such a number would suggest.
But industry said its own experience suggests otherwise.
It is also noteworthy that there are already six notified bodies based in Germany that have been designated against the MDR and three in the Netherlands. But no other country has more than one designation.
Questions arise over whether there is likely to be a hiatus now in the nomination of notified bodies designated under the MDR and IVDR due to COVID-19 and due to the challenges for joint assessment teams to carry out audits of notified bodies at a time when social distancing is enforced.
Sources close to the commission told Medtech Insight that the majority of current applications have passed the on-site assessment stage, as is indicated in the information on state of play of the designation process presented recently to the European Commission’s Medical Device Coordination Group (MDCG) and stakeholders.
In other words, although the travel restrictions imposed as a result of the pandemic have had an impact on the scheduling of on-site assessments relating to the receipt of new preliminary assessment reports (PARS) since the outbreak, the subsequent steps of the designation process, for example, the review of the corrective and preventive action (CAPA) plans, notification and designation, have not been affected, and continue to progress.
In yet more news about delays in the infrastructure that is critical to the full implementation of the MDR and IVDR, late June saw the European standards bodies CEN and CELENEC reject the European Commission’s already late standards request.
The existing standards under the current medical device directives need to be aligned with the new regulations so that industry can cite compliance with the updated standards as evidence that it should be in compliance with the General Safety and Performance Requirements (the MDR equivalent of the MDD’s Essential Requirements).
It looks unlikely that a new standards request will be presented to CEN and CENELEC before the first quarter of next year, meaning that one of the cornerstones of the new EU medical device regulations will simply not be ready on time.
EU medtech industry association MedTech Europe was already pre-empting the lack of availability of standards earlier this year, and has come up with a pragmatic way forward based around existing standards.
But with nothing yet official, industry is effectively in a legal limbo.
The new version of the European medical device database, Eudamed 3, is being designed to support the implementation of the MDR and IVDR and has six main modules: actor registration; unique device identification (UDI)/device certificate registration; notified body certificates; clinical investigations; market surveillance; and vigilance.
It is a cornerstone of the new MDR and IVDR, providing critical transparency and traceability. Its six main modules are interlinked and will provide an unprecedented oversight of which products are on the EU market where, how they are performing and how safe they are.
While Eudamed 3 was intended for launch at the same time as the full application of the MDR, the database has been beset by the type of delay that was predicted by many experts who cite historic problems with the vast majority of EU databases developed by the European Commission..
The database is now due to go live in its entirety in May 2022. The notice to trigger the go-live will be published in 2022, after a positive independent audit to assess that Eudamed has achieved full functionality and meets the functional specifications..
After much debate over whether individual modules of the database could go live before the database goes live in its entirety, the commission has now agreed that from 1 December this year, medtech manufacturers should be able to register – voluntarily ̶ in the actor registration module.
Authorized representatives, importers, and system/procedure pack producers will also be able to register from that date. The Single Registration Numbers (SRNs), which each Eudamed user must have, are also due to be available by then to support registration.
So now, an important document to look out for during the third quarter of this year is an implementing act providing detailed arrangements for setting up and maintaining Eudamed 3, as well as news on other modules going live early.
July saw progress, at last, on the appointment of members to the expert panels, with the aim of nominations being made public by the end of July.
These panels need to be in place for notified bodies to be able to complete conformity assessment of certain high-risk devices.
These panels have a variety of roles in supporting the more technical and product-specific aspects of implementation, and need to be in place for notified bodies to be able to complete conformity assessment of certain high-risk devices by performing a review of the notified body clinical evaluation consultation procedure (under the MDR) and performance evaluation consultation procedure (under the IVDR) for certain high-risk devices, namely class III implantables and class IIb active devices intended to administer and/or remove a medicinal product and Class D IVDs under the IVDR.
The next step will be to establish expert panels for the MDR’s clinical evaluation consultation procedure and IVDR’s performance evaluation consultation procedure.
Notified bodies that assess class III implantables and class IIb active devices intended to administer and/or remove a medicinal product should, except in certain cases, be obliged to request expert panels to scrutinize their clinical evaluation assessment reports and submit an opinion on them.
The process, known as the Clinical Evaluation Consultation Procedure (CECP), in the case of the MDR, can take up to 60 days, and must happen before notified bodies are able certify new products as conforming to EU requirements.
Because of the delays in setting up the expert panels, there will now be a build-up of applications for clinical evaluation of these innovative devices.
It could therefore take some considerable time before certificates are issued, especially because notified bodies’ auditing activities are being hampered by social distancing and travel restrictions and they are only able to conduct virtual audits.
Guidance so far states that initial audits should generally not be carried out virtually but should be conducted in person. (Also see "Manufacturers That Are Nearly MDR-Ready May Lose Their Advantage Unless Audits Can Take Place Virtually" - Medtech Insight, 7 May, 2020.)
The challenges inherent in the new role, under the MDR and IVDR, of the Person Responsible for Regulatory Compliance (PRRC) meant that the launch of a not-for-profit European association representing those taking on this role in June attracted a high level of interest.
The MDR and IVDR require that the supervision and control of the manufacture and the post-market surveillance and vigilance activities of medical devices are carried out within the manufacturer’s organization, and also at the level of authorized representatives and importers, by a PRRC, who, among other things, oversees manufacturing.
With many unknowns regarding new this role, a new association, TEAM-PRRC, has taken on the remit of supporting its members by analyzing available relevant requirements and guidance and trying to influence related developments. It aims to promote greater security of the PRRC professionals themselves, given that the function carries considerable responsibility and potentially weighty personal liability.
It is already clear that the medtech sector has some very big technical and political challenges ahead and is swimming in uncertainty and in urgent need of greater clarity.
But the political situations between the UK and the EU and between Switzerland and the EU, as well as Turkey and the EU, have made implementation of the MDR and IVDR even more complex.
The UK’s future regulatory pathway was still under discussion up until Medtech Insight was going to press and a new announcement was made. This meant that it had been unknown whether the UK would essentially continue to falling into line with EU rules after 31 December and the end of the EU/UK Brexit withdrawal period, or whether it would choose to apply its own rules or even associate itself with the rules of a different market, like the US, for example.
At last there are more clues about how the UK will move forward. The latest news, just published by the UK regulator, the Medicines and Healthcare products Regulatory Agency (MHRA), is that the UK will continue to use and recognize the CE marking for medical devices and IVDs until 30 June 2023. Certificates issued by notified bodies based in the European Economic Area will, therefore, continue to be recognized in the UK until that date.
This puts an end to the previous UK position, and to concerns that if the UK still leaves the EU with at the end of the year with no deal that EU notified bodies and their certificates would no longer be recognized in the UK.
Ironically, this would have included the only remaining UK notified body, BSI UK.
This will be a welcome reprieve for BSI, although it had already set up a Dutch notified body to which most BSI UK medtech and IVD certificates have been transferred. BSI Netherlands is designated against the medical device directives and the MDR and IVDR. BSI UK had been among the first of the EU notified bodies to be designated under the MDR and the IVDR.
Also announced by the MHRA is that there will be a new UK regulatory pathway and product marking from 1 January 2021 for products being placed on the UK market for those that wish to use it. This will be enforced from 1 July 2023, when companies will have to meet new UK requirements and place a UKCA mark on devices launched in Great Britain. (Also see "UKCA Mark Will Be The Post-EU Route To The British Medtech Market In January 2021" - Medtech Insight, 2 Sep, 2020.)
This means that there will be new rules that industry will be able to choose to comply with, and these are still under discussion in the context of the UK's Medicines and Medical Devices Bill.
From 1 January 2021, the MHRA will be able to designate UK conformity assessment bodies (CABs) to conduct assessments against UK requirements for the purpose of the UKCA mark. UK notified bodies, known as "Approved Bodies," with designations under the MDD, IVDD or AIMDD, will have their designations rolled over automatically, without having to undergo a new designation process.
Switzerland, meanwhile, is still trying to work out the basis for its future relationship with the EU, and indeed the UK. It currently has one notified body, SQS ̶ Schweizerische Vereinigung für Qualitäts- und Managementsysteme, designated under the MDD (although none under the IVD Directive), and no new Swiss notified bodies are expected to be designated under the new EU regulations until the Swiss-EU mutual recognition agreement is finalized.
And, because of a similar political issues, no Turkish organization can apply to be a notified body under the MDR or IVDR until the Turkish customs agreement has been signed. This is a potentially big hit to notified body numbers, as Turkey has five notified bodies under the MDD and one under the IVDD but none can be designated under the IVDR or the MDR until the Turkish customs agreement is finalized.
So, in conclusion, the next eight months are critical for the medtech sector. Is this a time when as many obstacles as possible are going to be removed so that the sector can focus whole-heartedly on compliance, rather than on the politics and uncertainties?
Or are we now at a stage where deadlines are going to need to be continually put back while COVID-19 wreaks havoc on the industry?
