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New Interpretation Of Current EU Rules Threatens Procedure Packs
Shutterstock: Sherry Yates Young
AMANDA MAXWELL amanda.maxwell@informa.com
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ome notified bodies are starting to aggressively enforce existing rules around procedure packs and systems; they are refusing to certify them unless the company involved has been through a full conformity assessment of all the products involved. Procedure packs are found in all aspects of the health-care system, gathering together a range of different medical devices – very often as many as 15 or 20, and from different manufacturers – in a single pack targeted towards a specific medical procedure. Under Article 12 of the Medical Devices Directive, according to Medtech Insight sources, there are two types of system and procedure packs, and the regulatory route depends on which category the packs fall:
What are procedure packs and systems? Procedure packs and systems save doctors and nurses time by providing all items in one pack in the order in which they are needed for a specific procedure. Traceability is also streamlined. An example of a system would be all the parts and accessories needed for a joint replacement surgery. An example of a procedure pack would be a first aid kit or an orthodontic kit.
• In one case, a company puts together various medical devices and instruments in a single box and sells it without making any changes to the labeling or packaging. In this case, the historic understanding is that those who put together these packs may go on sell them without going through the necessary full conformity assessment, as long as they have checked the mutual compatibility of the devices, supplied the relevant information and instructions, and there are internal methods of control and inspection. • The second case applies to those who resterilize procedure packs. Although the law allows for the resterilization of procedure packs under Article 12, when the sterilization is done in accordance with the original manufacturer’s instructions, in practice this is not feasible with devices from 15-20 different manufacturers. In this case, companies must treat the procedures pack or system as a device in itself and go through the full conformity assessment procedure for the pack. Because of the positions taken by some authorities and their apparent influence on some notified bodies, the interpretation of the current Medical Devices Directive rules around procedure packs and systems means that those who put them together under the second bullet point, are increasingly being treated as virtual manufacturers for each device in the procedure pack. This means that instead of having a conformity assessment procedure for the pack as a unit, companies that compile a procedure pack need to go through the full conformity assessment procedures for each device in the pack, even though each
FROM THE EDITORS OF: THE GRAY SHEET, CLINICA, START-UP AND MEDTECH INSIGHT NEWSLETTER
of the companies that supply the original devices within the pack will have already done this. Those putting the packs or systems together will also need to supply all the technical documentation for each of the products in the pack, and cannot show the original manufacturer name, nor the CE marking on any of the individual products. This goes against the historic interpretation of the Directive’s rules and could make the practice of putting together procedure packs unmanageable and unprofitable, multiple industry experts, who wish to remain anonymous, told Medtech Insight. At the moment, there is a high level of concern and uncertainty among manufacturers about this issue. The EU MedTech Europe trade association confirmed to Medtech insight that it is planning to create an internal ad-hoc group to work on the Medical Device Regulation requirements for systems and procedure packs. The group emphasizes that this is a matter that industry wants addressed, warning that, otherwise, the advantages offered by systems and procedure packs in surgery and to the health-care system generally, will be lost. Competent authorities, it seems, are after some clarification to ensure the current regulatory framework under the MDD is being properly interpreted. It seems that one competent authority will ask the Competent Authorities for Medical Devices (CAMD) group to coordinate a market surveillance program on procedure packs and systems in an attempt to persuade the Commission that device-specific guidance is needed.
What Article 12 of the MDD says on the procedure for systems and procedure packs, and the procedure for sterilization: • Those who put CE-marked devices together within their intended purpose and within the limits of use specified by their manufacturers to place them on the market as a system or procedure pack, must draw up a declaration stating that they have: • (a) verified the mutual compatibility of the devices in accordance with the manufacturers’ instructions and carried out operations in accordance with these instructions; and • (b) he has packaged the system or procedure pack and supplied relevant information to users incorporating relevant instructions from the manufacturers; and • (c) the whole activity is subjected to appropriate methods of internal control and inspection. • If these conditions are not met, for example the system or procedure pack incorporate devices which do not bear a CE marking or where the chosen combination of devices is not compatible in view of their original intended use, the system or procedure pack shall be treated as a device in its own right and as such be subjected to full conformity assessment procedures. • Those who sterilize such systems or packs, or other CE-marked medical devices designed by their manufacturers to be sterilized before use, must sterilize them in compliance with the Directive and involve a notified body in aspects of the procedure relating to the obtaining of sterility until the sterile package is opened or damaged. They must draw up a declaration stating that sterilization has been carried out in accordance with the manufacturer’s instructions. • These systems and packs do not need to feature an additional CE marking. They shall be accompanied by the information supplied by the manufacturers of the devices which have been put together.
Published online 07/18/2017
With EU Notified Body Numbers Tumbling, How Do Manufacturers Ensure Seamless Transition To MDR? ASHLEY YEO ashley.yeo@informa.com
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U medical device manufacturers must think they have done something really bad in a former life: making the huge adjustments necessary en route to complying with the Medical Device and IVD Regulations (MDR/IVDR), in force since May 2 | Medtech Insight
25, 2017, is a big enough challenge. But add to that the uncertainties of Brexit and the growing pressures on their notified body (NB) partners, and medtechs might just see it as a costly journey of indeterminate length, in an uncertain direction
and probably with delays. And when they eventually arrive, it could be in the company of a different NB partner to the one they started out with. In spite of the uncertainties of the MDR and Brexit, preparation is everything. © Informa UK Ltd 2017
That was the clear message from a Hogan Lovells double-handed webinar this week on “Preparing for Brexit and the new MDR and IVDR.” The speakers convened by the law firm described a landscape of huge change that medtechs not only need to master themselves, but also ensure that their stakeholder partners – authorized representatives (ARs), distributors, importers, suppliers and NBs – can handle what is expected of them. UK BREXIT REPEAL BILL IN DEBATE SOON And although there is a creeping sense of a conditional tense being timidly applied to Brexit (or at least to “hard Brexit”), the UK government is keen to press on unabashed. Yesterday, it published its Great Repeal Bill (aka the European Union (Withdrawal) Bill), which will cancel the European Communities Act of 1972 and remove the supremacy of EU law. (Also see “UK Being Edged Toward The EU’s Back Door – Is It So Simple?” - Medtech Insight, 28 Nov, 2016.) It will probably be debated in the fall, and will need to be passed by March 29, 2019, when the UK is scheduled to leave the EU. Between now and then, medical technology companies will need to have resolved many issues that could well harm their competitive positions. And under current schedules, with Brexit due to take place before the MDR and IVDR come into full application (May 26, 2020 and 2022, respectively), Hogan Lovells recommends companies factor Brexit as well as MDR/IVDR compliance into decision making as of now. NB’S CONFORMITY ASSESSMENT COSTS SPIRAL NBs’ conformity assessment costs are expected to rise two to three times higher than present levels, as NBs transition to the MDR/IVDR. Clinical study/evaluation costs could rise four-fold. (Also see “EU MDR Set To Rack Up Costs For Industry, German Medtechs Say” - Medtech Insight, 13 Jul, 2017.) And there will likely be fewer, more specialized NBs. Hogan Lovells suggests the number of EU NBs accredited under the MDR could drop to 35 (under the Medical Devices Directive, 93/42/EC), from 57 at present. medtech.pharmamedtechbi.com
This substantial drop may create big problems for manufacturers if the NBs they are using decide not to apply for re-designation under the new regulations. NBs can only apply for this “relicensing” as of November 26. IVD-accredited NB numbers are expected to remain stable, at around 20 (from 22 at present). But some device and IVD manufacturers will need to look for new NBs as soon as possible, mindful that their NB might also reduce its scope or withdraw from the sector entirely. (Also see “EU Notified Bodies ‘Under Pressure And Scared’” - Medtech Insight, 3 Jul, 2017.)
business. (Also see “UK Medtech One Year Post-Brexit Vote: Still In The Land of Uncertainty” - Medtech Insight, 4 Jul, 2017.) MANUFACTURERS’ STRATEGY: TEAMWORK, PLANNING, INCLUSIVENESS It’s clear that to minimize disruption to business, manufacturers must understand the potential issues for NBs that could lead to delays in conformity assessment. Hogan Lovells advises them to evaluate their portfolios, plan well and budget properly for the transition to MDR/IVDR, which means
The substantial drop in notified bodies may create big problems for manufacturers if the NBs they are using decide not to apply for re-designation under the new regulations.
WAITING LISTS FOR NEW CLIENTS AT NBS Some NBs are reportedly not taking on any new clients at present, and waiting lists are said to be reaching 6-9 months. Another potential complication is that auditing re-designation may take up to 12 months, so it is possible that an NB may not be able to start conformity assessment work until late 2018/early 2019 – leaving only 18 months for them to complete their compliance work under the MDR. Furthermore, NBs are reportedly saying that it will take 18-24 months to transition all their clients under the MDR. This gives an indication of NBs’ ability, in general, to work within the timeframes of the MDR and IVDR. Another question is how do NBs prioritize their work for manufacturers – first come, first served? Largest first? NBs are actively seeking guidance on this so that customers can be treated fairly. And as to the Brexit question and how it affects the UK’s five NBs – BSI, LRQA, Amtac, SGS and UL – they have considered if setting up an operation in another (EU) country, for instance, the Netherlands, might provide solutions for them and their clients in matters of continuity of
engaging internally and externally, setting up a transition team of several people (including management), and including independent third parties, for balance. Whether that transition is seamless depends on how much they can do now. But there might also be business opportunities for some companies in all the confusion. MDR/IVDR-inspired portfolio evaluations might lead some companies to drop certain products that might then be picked up by third parties. Equally, companies’ competitive positions might be improved by rivals leaving an industry sector, simply because they don’t have the resources. Companies dropping out of certain markets is thought to be a fairly likely scenario in the IVD sector. And some companies use CE marking to ease their entry into other, global markets. This happens for some 30% of CEmarked devices, says Hogan Lovells. The unspoken warning is medtech manufacturers may think they are at the start of the MDR/IVDR and Brexit journey, but time – and their potential NB options – are already running out or narrowing. Published online 07/14/2017 Medtech Insight | 3
EU Notified Bodies ‘Under Pressure And Scared’ AMANDA MAXWELL amanda.maxwell@informa.com
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otified bodies are “under pressure and scared.” That is the view of Gert Bos, executive director and partner at Qserve group consultancy. Some are afraid of losing their designation or having their scope reduced. And they are under pressure because they must up their game, Bos told attendees of the Knect 365 MedTech Summit in Amsterdam on June 19. Bos. was previously one of the EU’s highest profile notified body representatives. He has previously served in pivotal roles at large notified body BSI and the EU notified body association, TEAM-NB. He explained that notified bodies have had to start preparing for MDR readiness and at the same time become a “new type of notified body.” Speakers generally agreed that the first of the notified bodies to be certified under the new regulations are likely to be certified in early 2019. This will just be a starting point, Bos suggested, as notified bodies will then need to plan, to schedule audits and, in all likelihood, tackle any deficiencies they might have. CLINICAL DATA CHALLENGE They need for notified bodies to be more independent in their reflections and to be stricter in ensuring high-level compliance, especially when it comes to clinical evidence, is impacting how they relate to manufacturers, he told the meeting. An increasing number of notified bodies are becoming more adept at helping manufacturers transition to meet the tougher clinical data requirements. But there is still is a big challenge – notified bodies are being closely monitored by designating and supervising authorities against more exacting requirements, and they are fearful that failure may impact their businesses, Bos said. Notified bodies will be speaking less in black and white terms, than they have in the past, about whether what a manufacturer is doing is right, he noted. “They will tell you that you have to make sure you are in compliance and that they will only verify afterwards,” he asserted, as is in line with the new regulations. “And it is up to you to make sure 4 | Medtech Insight
that they come and audit,” he told the manufacturers at the MedTech Summit. Clinical data has been a particularly challenging area when it comes to communication between notified bodies and manufacturers Recently, many companies have been struggling without enough clinical data to address the requirements of the latest EU guidance document, Meddev 2.7/1 rev 4 (which is generally being enforced by notified bodies), and the response from notified bodies has been very black and white. “We have seen that some have been struggling, but on the other hand, a lot are becoming more and more successful. Notified bodies are now handling the transition towards compliance with the latest guidance document on clinical evaluation, Meddev 2.7/1 rev 4 much more smoothly,” Bos said. UK NOTIFIED BODY ISSUES Graeme Tunbridge, group manager, devices regulatory affairs at the UK’s Medicines and Healthcare products Regulatory Agency, expects to see the number of notified bodies across Europe edge downwards because of the challenges with the new regulations. He commented that notified bodies can make their applications for redesignation from November 26 of this year, and he expects that the UK’s five notified bodies will seek to be redesignated under the MDR. It is not going to be easy, he acknowledged. But the MHRA is working hard to communicate to notified bodies what the expectations are and to help them through the process. We aim to provide a high degree of challenge to the notified bodies so that when they submit their applications, they will be ready, and are able to obtain designation quickly, he said. This is a difficult balance to achieve. “But it is clear that the joint assessments by member state designating authorities, and the degree of scrutiny and oversight by all member states will mean that notified bodies have to have their act in order to be designated and survive under the MDR,” he said,
UK SME’S SURVIVAL TACTICS Rebecca Sheridan, head of quality assurance and regulatory affairs at Phagenesis, a smaller company (SME), which aims to treat the cause of dysphagia, reminded the audience that the choice of notified body is critical, adding: “We have challenges enough with SMEs as notified bodies”. Her company decided to change its notified body because of concerns over whether the initial notified body would choose to be redesignated under the MDR or not. Phagenesis then chose to settle with a large notified body in the UK. The firm did this, Sheridan said, due to concerns over the impact of Brexit. She explained that Phagenesis wanted stick with the “herd” – meaning with a large mass of companies and the potential influence that wields – should any Brexit-related issues need to be addressed. NOTIFIED BODY WORKLOAD Sheridan mentioned slower services by notified bodies, a matter that was taken up by Bos. “Can you blame them? They have so much more to do,” Bos said, including unannounced visits, all the assessments and preparing for the MDR. With this workload everyone is looking for additional resources, he added. He urged industry to stop complaining, because this is the new reality. Instead, it is time to focus on what should be done when and to collaborate on priorities. Bos noted that when speaking at conferences, notified bodies are quite selectively focusing on several key elements where they expect their reviews and reflections will be more stringent, such as clinical evaluation, audit elements and quality system requirements. They will explain to you in as much detail as possible what they are already preparing for, and what they anticipate you need to do – but they will tell you what you have to do, not how you have to do it, he stressed. And companies should be aware that they themselves need to create a whole range of very strict contacts with their distributors and suppliers, including © Informa UK Ltd 2017
With so much pressure on them as a result of the September 24, 2013, Regulation on designation and supervision of notified bodies and Recommendation on notified body audits, Bos said that not only had the numbers of notified body numbers designated under the Medical Devices Directive dropped from 87 to the some 56, but that he expected another 10-15 would drop out in the next 6-12 months. This would leave just 41-46 notified bodies in total. He acknowledged that differently to the MDD, the number of notified bodies operating in the IVD sector appears to be remaining stable.
clauses relating to data exchange, Bos said. Bos also said that waiting lists for notified body services are generally increasing and that notified bodies are being careful in accepting transfers from companies who are leaving other notified bodies because of liability risks. He also noted that line extension reviews are becoming cumbersome. COMPLEX REDESIGNATION PROCESS The redesignation of notified bodies is going to be a very complex process, Bos warned at the meeting. It will take at least 18-24 months, he said. But some are suggesting that the period is actually 18-24 months starting after the applications for resignation are submitted, beginning November 26. That adds up to two to twoand-a-half years’ time, Bos noted. Considering there is only three-year transition period for the MDR that has already begun, it is clear how little time there is ac-
tually going to be for notified body assessments. So it is little surprise, Bos suggested, that notified bodies are saying if your dossier is ready in 2021, then that is early enough: They will probably not have time before that. But that is not the best approach, Bos stressed, because notified bodies need to use the entire “seven years of transition.” He pointed out that industry and stakeholders don’t have seven years, but more like three years and some possible residual time. He emphasized the need to get black and white information on whether, if your product is fully compliant now, you can continue to sell it for seven years. “That also means obtaining a commitment – and I have not heard any notified body commit to this yet – that its clients’ certificates that are going to be valid until, say, 2022, will be renewed early in the coming years,” he said, that is, before May 26, 2020. But a company is not very interactive with your notified body, he warned, that will not happen. Moreover, companies will not have cer-
tificates that last until May 26, 2024, unless they are ready to be reviewed in ample time. Once a notified body is designated against the new MDR/IVDR – which could be in 2019 most likely – they may not have time to reassess compliance against the MDD when compliance against the MDR becomes the new priority. At this point, companies could request notified bodies to assess those processes that are already MDR compliant at an early stage, with a view to a partial audit against the MDR requirements, while those that are not yet MDR compliant could still be assessed against the MDD requirements in the interim. Even if the notified bodies do have time to start assessing against the MDD again, they are likely to suggest doing half an MDR assessment because their time will be so pressurized and there will be so many clients to get through. According to Bos, the message from notified bodies will be: “We can’t prepare a new one under the MDD with so little time to do all the other company’s assessments too, and then review the same aspects of that product again under the MDR; there will just not be time.” He advised the meeting that everyone needs to act smart during the whole transition, and focus on when to do what with whom. Companies have to be smart or they will never have the resources to be ready on time, he warned. Published online 07/03/2017
Industry Supports Introduction Of Australian Notified Bodies, But With Conditions NEENA BRIZMOHUN neena.brizmohun@informa.com
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edtech companies operating in Australia have shown broad support for the introduction of Australian-designated notified bodies undertaking conformity assessments of products, but they insist that manufacturers should not be responsible for the costs involved in designating them. In addition, Australian notified bodies should not be prevented from assessing medtech.pharmamedtechbi.com
high-risk products that under the current rules (i.e., Regulation 4.1) require conformity assessment certification from the Therapeutic Goods Administration, according to newly published stakeholder feedback to the TGA’s consultation on introducing Australian-designated notified bodies. The TGA is hoping to introduce a system for designating Australian notified bodies – also known as conformity assessment
bodies (CABs) – on Jan. 1, 2018. It will consider the feedback during its development of a policy position for future changes to the Therapeutic Goods Regulations 1990, and when it develops guidance on the designation of Australian CABs. The introduction of Australian CABs would remove the need for the TGA to audit some of the 300 or so applications it receives annually for inclusion in the Medtech Insight | 5
Australian Register of Therapeutic Goods that are based on conformity-assessment certificates (CE marks) granted in the EU, according to the consultation document, which was released last November. The Australian device industry has expressed dissatisfaction with the time it takes to process applications for inclusion in the ARTG when an application audit is undertaken. Eliminating the need for an application audit could save companies six months, the TGA has previously said. Mandatory application audit requirements aim to manage the TGA’s risk of relying on overseas certification issued by CABs for which the agency has no direct oversight or control, focusing on high-risk products. The idea is that if the CAB is designated by the TGA then the risk would be managed through the designation process rather than auditing of individual applications. While medtech respondents to the consultation expressed support for Australian-designated notified bodies, they rejected a TGA proposal to recover some or all of the costs involved in designating CABs via a charge on all medical device sponsors. Instead they agreed with another TGA proposal for these costs to be recovered directly as fees from CABs. For example, Medtronic commented that it was not appropriate to charge the rest of the medical device sponsors for assessment costs for services they had not used. Johnson & Johnson suggested that CABs could “then recover assessment and evaluation costs from applicants at a potentially higher rate than the TGA but with the possible benefit to applicants of guar-
anteed faster review times.” Stakeholders also disagreed with the TGA’s suggestion that some device types or classes should continue to be required to hold TGA conformity assessment certification. “The proposal to restrict high-risk devices under [Regulation] 4.1 is not acceptable,“ said Medtronic. “All device classes should be able to use the option of utilising the Australian CAB,” the company believes, explaining that any CAB potentially applying for – and subsequently approved for – Australian designation would be an organization with global operations and therefore would have the relevant resources and expertise. Excluding high-risk devices may also result in the model being financially non-viable for the Australian CABs, the company commented. “The ideal outcome would be for companies to lodge one application to the European Notified Body (also acting as an Australian CAB) and the assessment is carried out at the same time avoiding duplication of efforts,” it said. Australian biotechnology industry group AusBiotech also expressed support for the introduction of TGA-designated CABs, but it questioned whether the proposed system would translate into real benefits to patients, industry and/or government by way of reduced review times and timely access, and/or reduced costs. “The consultation paper acknowledges that the new designation system will take the TGA a considerable amount of time and effort to establish,” AusBiotech said in its response to the consultation. Most listings on the ARTG are based on EU certi-
fication without application audits, or are products that would not meet the criteria, such as those that fall under Regulation 4.1, the trade group noted. As such, AusBiotech has urged the TGA to conduct research to estimate how often sponsors/manufacturers are likely to use an Australian designated body (to avoid the time involved with the TGA auditing an application) and whether the Australian market would be willing and/or able support the cost of the proposed system. “We suggest that the most pragmatic and preferable option for sponsors/manufacturers would be to utilise a body that was able to concurrently undertake Conformity Assessments for both Europe and Australia.” Plans to introduce a framework for designating Australian CABs follow the government’s September 2016 response to recommendations from an expert panel review of the regulatory framework for both drugs and medical devices (the Medicine and Medical Devices Regulation (MMDR) review). The MMDR also included regulatory reforms to increase flexibility in pre-market assessment processes by increasing the use of assessments from comparable overseas regulators. A public consultation was launched last month on the use of marketing approvals by comparable overseas regulators for a device in an overseas market to support its inclusion in the ARTG. The deadline for submitting comments on that consultation is June 30. Published online 06/13/2017
45% Leap In Notified-Body Certificates Withdrawn From Device Firms
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ankruptcy, invoices not paid, and inability to close major non-conformities were among the many reasons that EU notified-body certificates were withdrawn from device companies in 2016, according to survey results from the TEAM-NB EU notified body association. But the 45% increase in TEAM-NB certifi-
6 | Medtech Insight
cate withdrawals last year, in addition to a consistent decline in the number of certificates issued, likely reflects the increasingly challenging EU regulatory environment faced by medtech, TEAM-NB suggests. In total, 1,881 certificates were withdrawn from device firms by TEAM-NB members last year, up from 1,294 with-
drawals in 2015, according to data reported in the association’s Medical Device Survey 2016, based on figures presented by 21 member notified bodies. (TEAM-NB has subsequently gained one additional member.) The total represents an average of 90 withdrawals per notified body last year. © Informa UK Ltd 2017
In some instances, the withdrawals resulted from a device company’s inability close major non-conformities. In other cases, it stemmed from financial issues. Decisions by firms to transfer to another, sometimes cheaper, notified body also factored in the data. According to TEAM-NB, the large overall increase may reflect increasing EU regulatory expectations and notified bodies tightening up their standards on companies as a result. Indeed, the European Commission’s plan of actions, including the joint audits by designating authorities of notified bodies, have made the environment much tougher, even in advance of the new Medical Device and IVD Regulations. The number of certificates withdrawn has been steadily increasing since 2013, but the spike in 2016 accelerates the trend. The 2016 rise was double the 22.3% increase in 2015. Meanwhile, the number of new certificates issued to device firms has steadily dropped since 2013, to a low of 4,098 new certificates in 2016. TEAM-NB speculates that the increase in requirements, and in the time it now takes to obtain certification, along with the number of current applications that don’t result in a certificate, is most likely affecting the number of certificates issues. Other interesting certificate-related data from the TEAM-NB survey: • The aggregate total of valid certificates issued as of 2016 also dropped – from 21,037 in 2015 to 19,753 in 2016. This averaged out to 941 per notified body in 2016, compared with 956 per organization in 2015; • Six of the 21 notified bodies issued more than 1,000 certificates in 2016, while five issued between 350 and 1,000, and 10 issued less than 350; and • In total, 91% of certificates were issued under the Medical Devices Directive, just 7% under the IVD Directive, and 2% under the Active Implantable Medical Devices Directive. STAFFING GROWS, BUT IS IT ENOUGH? As certificate numbers are dropping, notified bodies are steadily growing in medtech.pharmamedtechbi.com
TABLE 1
TABLE 2
TEAM-NB Certificate Withdrawals
Team-NB Certificates Issued
YEAR
NUMBER OF CERTIFICATES WITHDRAWN BY TEAM-NB NOTIFIED BODIES
YEAR
NUMBER OF NEW CERTIFICATES ISSUED BY TEAM-NB MEMBER NOTIFIED BODIES
2016
1,881
2016
4,098
2015
1,294
2015
4,480
2014
1,058
2014
4,535
2013
881
2013
5,061
TABLE 3
Notified Body Staffing Average number of full-time equivalents working in the medical devices sector FULL-TIME EQUIVALENT EMPLOYEES
FULL-TIME EQUIVALENT CONTRACTORS
2016
86
25
2015
77
28
2014
65
25
2013
46
26
YEAR
terms of staff size. There was a 12% increase in the number of full-time employees working with TEAM-NB members in 2016. This is the fourth year in a row that there has been an overall increase. But, interestingly, this staffing growth comes as the overall number of EU notified body organizations are declining. The number of TEAM-NB notified body members dropped from 28 to 21 between 2013 and 2016. And the number of EU notified bodies overall, regardless of membership, has fallen from almost 80 several years ago, to 54, including a recent drop-out that occurring in only the past few days. (Also see “More EU Notified Bodies Bite The Dust” Medtech Insight, 17 May, 2017.) During the three years that the number of TEAM-NB members have dropped, full-time employees grew by 87%. The increase in full-time-equivalent hiring reflects the need by notified bodies to meet new demands and anticipate the additional workload that will be demanded by the new EU requirements. But Françoise Schlemmer, director at TEAM-NB, said that the most recent 12% workforce increase has probably not yet trickled
down into actual improvements in notified body capacity. It takes a year to train a new auditor, she pointed out. Device companies and others are questioning whether notified bodies will have the capacity available that is needed to address upcoming responsibilities under the Medical Device and IVD Regulations. The new regulations enter into the force of law on May 25, and will fully apply in 2020 and 2022, respectively. While there is a long transition period for companies to achieve compliance with the new regulations, all products – both new devices and those currently on the market – will ultimately need to be reviewed under the new rules. This means that a massive number of audits will need to be carried out in a limited amount of time. Resources will be particularly tight for IVD products, because some 85%90% of IVDs will need to be reviewed by notified bodies under the new regulations, up from only about 10%-15% that require such oversight under current requirements. Published online 05/22/2017 Medtech Insight | 7