When it comes to the medtech space implementing the second half of a 19-point action plan from the Medical Device Coordination Group, it’s pretty much yellow – or slow – across the board. At least that’s the assessment by notified body BSI Group.
The MDCG’s plan, released in August, offered a roadmap for how medical products can be certified to the E.U.’s new MDR and IVDR regulations within prescribed transition time frames. The Position Paper, MDCG 2022-14, also included recommendations for boosting the work output of notified bodies and asked NBs to increase their use of hybrid remote/onsite audits to quicken the compliance process. (READ MORE: “MDCG Urges Compliance To E.U.’s MDR/IVDR In 19-Point Action Plan,” MEDIcept Insight, Sept. 2, 2022)
During a mid-October presentation at BSI’s 11th Annual Medical Device Roadshow, Jayanth Katta, BSI’s Regulatory Director & Head of Medical Devices, addressed every point of the action plan and color-coded each using the traffic light colors green, yellow and red to indicate how far along, in his view, each action point is.
Part one of this MEDIcept Insight covered MDCG action points one through nine, which included a mix of green, yellow and red designations. (READ MORE: “Seeing Red (And Yellow): Notified Body BSI’s ‘Scorecard’ Shows Plenty Of Work Needed To Meet E.U.’s 19-Point MDR/IVDR Compliance Plan (1 Of 2),” MEDIcept Insight, Oct. 12, 2022)
But in part two of this Insight, covering action points 10 through 19, all but one were given a mediocre yellow label by Katta.
Katta’s comments below, made on Oct. 12, were lightly edited for content, brevity and clarity.
10. The revision of Sec. III.6 of MDCG 2019-6 Rev. 3 regarding the meaning of “personnel employed by the notified body” within the MDR/IVDR. (YELLOW)
“MDCG 2019-6 says that, if a certain number of staff carries out certain activities, such as decision-making, they must be internal to the notified body. And this document …. says that being ‘internal’ means that you have to be based in the Netherlands and you have to be directly paid by a Netherlands notified body. Now, that’s quite unrealistic to some notified bodies, such as BSI, which is a global organization. And our thinking is, irrespective of where the person is, we want the best person, best qualified person, to make a decision. And so the notified bodies have been fighting the commission on that requirement. …So that’s why it’s in yellow.”
11. New guidance shouldn’t be applied to ongoing processes or applications already launched by a conformity assessment body for designation and/or a manufacturer for conformity assessment unless use of the guidance yields increased process efficiency. (YELLOW)
“No. 11 is about MDCG guidance and the time it takes to implement them. Each competent authority has a different view of these documents. Some competent authorities interpret the requirements in a way that, as soon as a new MDCG document gets published, they expect the notified bodies to magically implement it the next day. And we know that’s not possible.
“So notified bodies got together and said, ‘The simplest way of dealing with it is if we agree on a timeline on how quickly we can implement a new MDCG document.’ They agreed on 12 months, up to 12 months, to implement the new guidance document once it gets published. It could be sooner if it’s a simple change, but it could last up to 12 months. So that was the proposal from the notified bodies.
“But we got a message from the Commission saying it’s not happy with that position. They think it shouldn’t be a simple 12 months; they want it to be a case-by-case approach. We were trying to avoid that case-by-case approach because it will cause so much administrative work. …So that’s why it’s in yellow, because there is some progress, but obviously there are some concerns raised.”
12. Notified bodies are reminded of their obligation to make their standard fees publicly available and consider the interests of SMEs in relation to fees. (YELLOW)
“Obviously, there are concerns that there are some manufacturers that are not able to find a notified body for MDR and IVDR. So these actions are aimed at making it easier to find a notified body. Action No. 12 is about the fees applied by a notified body. Now, each notified body has its own assessment model, so the fees are all different between notified bodies. This action is aimed at trying to standardize how notified bodies present their fees.
“They’re also saying that the notified bodies must take into account the interest of SMEs, small and medium-sized enterprises, when we are thinking of fees, and this is a bit more challenging. …If you look at the legislation, there isn’t a single requirement which differs based on the size of the organization. If you have a device, you must comply with all the requirements that apply to the device, it doesn’t matter whether you’re a five-person organization or a 500-person organization or a 5,000-person organization. The requirements are there, you must meet it. So legislatively, it’s very hard to change fees based on the size of the company.
“But there are certain things which are already proportional to the size of the company. …The duration of your QMS audit, whether it’s Stage 2 or a surveillance audit, is proportionate to the number of employees you have. So if you’re a big organization, you have more audit days, so you pay more; if you’re a small organization, you have fewer employees, so you pay less. So there’s already some proportionality there. …So there’s some work happening in terms of supporting the SMEs. So that’s why No. 12 is in yellow status in terms of the progress.”
13. Notified bodies should develop schemes to allocate capacity for SMEs and first-time applicants. (YELLOW)
“This is a bit more challenging, and the reason is that a majority of notified bodies can say that more than 50% of their client base is SMEs. For BSI, more than 50% of our clients are SMEs. So how do you allocate more capacity if the majority of your capacity is already taken by SMEs? Yes, there are some big medtech organizations, but they are few in numbers. A majority of the medtech sector is made up of SMEs. So we don’t know how to implement this, to be honest. …So that’s why that’s in yellow.”
14. Manufacturers are reminded to ensure timely compliance with MDR requirements. (YELLOW)
“This is a reminder to the manufacturers that they should not hope that the date of transition will be moved. They should apply now, don't wait. …The Commission knows and the MDCG knows that not enough applications have been received, not enough good quality applications have been received. So it's asking the manufacturers to step up. …There are many clients who still haven't even applied and that's a concern.
“And our experience as well on the IVDR side is when the data transmissions got pushed out, a number of our manufacturers withdrew their applications or delayed their submission timelines. So that’s an ongoing concern that if more time is given, you’re just basically kicking the can down the road and not really addressing the problem.”
15. Notified bodies and manufacturers are encouraged to organize structured dialogues before and during the conformity assessment process. (YELLOW)
“This is one that has attracted some attention, because most manufacturers like to talk to their notified bodies, which is fair. They want to understand what the requirements are, what they should do to be successful as part of the certification process.
“This document is saying to have more structured dialogue pre- and post-certification, and during the certification process. Now, if I think of the extremes of this, when you have a dialogue with the manufacturers, between manufacturers and the notified body, some questions are related to, ‘What needs to be done? What are the requirements that need to be fulfilled? What is the process for certification?’ These kinds of questions are perfectly OK to be part of a structured dialogue because they don’t constitute consultancy. It’s simply trying to explain what the legislation needs are and what the manufacturer should do. So that is OK and that is allowed, per the legislation.
“Then, on the other end, we have questions like, ‘How do we comply with a certain registry or certain requirement?’ That is not allowed to be part of this dialogue because a notified body cannot tell the manufacturers how to comply with the requirements. That is consultancy.
“But there are these questions in between, which is where most manufacturers want answers. ‘Is our clinical trial design adequate? Do we have enough patient numbers? Are our endpoints appropriate? Do we need to repeat some of the biological safety tests?’ Those are the kinds of questions that are in the middle. That is where the manufacturers really want the notified bodies to go. But it’s unclear as to whether that is allowed or not.
“Notified bodies are cautious about structured dialogue because we are very unsure where to draw the line. And if we cross the line, we get punished quite severely. So that’s why there is this caution from notified bodies in answering those type of questions in the middle. …It’s in yellow status because we know we can do certain things. We know we can’t do certain things. I think what we are awaiting is guidance on that middle bit, what is possible and what is not.”
16. “All parties involved” should step up communication with manufacturers by means of webinars, workshops, targeted feedback, and informative sessions. For example, notified bodies are invited to work on common guidelines for firms to assist them in the application phase. (YELLOW)
“This is an action for notified bodies to see if they can produce common guidelines, which will satisfy all the notified bodies. Notified bodies worked really hard on this during the summer. And there is now a coalition paper that [was published in October], which is a Best Practice Guidance for Technical Documentation. This was prepared by collecting 20 different guides from notified bodies, putting them all together, and harmonizing our expectations. …So there’s a lot of work happening from the notified bodies on this one.”
17. Guidance to notified bodies to issue certificates under conditions. (YELLOW)
“This one has attracted a lot of attention. The MDCG document basically encourages the notified bodies to consider issuing certificates with conditions. But what has happened is, somehow things got lost in translation. And if you look at some of the medtech organization papers, they’re saying, ‘Notified bodies should issue provisional certificates, conditional certificates. If a manufacturer has made an application, why don’t you issue a certificate now and verify the requirements later? Issue a conditional certificate or the provisional certificate, because then you can go faster.’
“But there is no such thing as a provisional certificate or a conditional certificate, those words are nonexistent in the legislation. There is no such thing. What the legislation does say is that the notified bodies can issue certificates with conditions. And what that actually means is, the notified body has verified compliance to the requirements. But even after that, there’s additional conditions on the manufacturer. That is certificates with conditions. And examples of those conditions could be, ‘This device must only be used as part of a particular study,’ or ‘This device must only be used in this patient population.’ So it’s a very, very rarely used mechanism.
“And it’s only applied when we believe the risk of the device is very high, or it’s very novel, and we have some concerns about its long-term safety and performance. In the last 20 years of BSI being a notified body, I think we’ve issued five or six certificates with conditions. It’s very rarely used. But it got misinterpreted by a lot of people.”
18. Guidance for “orphan devices” to meet legal requirements. (YELLOW)
“This action is looking at how do we try and help those orphan devices. There is a taskforce that is going to be set up on this. And the first task [will be to] define what an orphan device is, and then start developing guidance based on case studies, what the regulatory challenges are, what the solutions could be, etc. So it’s in yellow status, because … there’s some work ongoing.”
19. Medicines authorities are urged to accept and efficiently process consultations by notified bodies regarding medical devices incorporating an ancillary medicinal substance and regarding companion diagnostics. (RED)
“No. 19 is in relation to the consultations that are required for device/drug combinations. It’s a reminder for competent authorities from the MDCG that the previously published document 2020-12, which says that if the device has already had a consultation, the competent authorities should not do a full consultation again. If there is no change in the device, no change in the medicine, substance, etc., they should do an abridged, short consultation under MDR.
“But our experience shows that’s not what is happening in reality. Most competent authorities are taking a lot of time completing the consultation. So there are huge backlogs. Some competent authorities are not even accepting applications because they just don’t have the capacity. So this is a reminder to the competent authorities that they should really do short consultations if the previous consultation still remains valid. It’s in red status because we haven’t seen any improvement yet. If things improve, then maybe that status can move to green or yellow.”
…And remember, with so much at stake with the rollout of the new regulations in the E.U., your company shouldn’t wing it when it comes to MDR/IVDR compliance. MEDIcept is your go-to source for comprehensive medical device regulatory solutions. We have a long history of success in helping clients achieve and maintain compliance with global regulations.