CEI Featured Article

Substantial Drop In Certificates Withdrawn By EU Notified Bodies: Why Now?

Analysis Article posted on 02 May 2018 on Medtech Insight
Author: Amanda Maxwell  |  Source of Original Article

Executive Summary

Data from TEAM-NB, the EU notified body association, shows a big drop in withdrawn certificates from device firms. Does this signal an improvement in the quality of manufacturers’ submissions to notified bodies?

During 2017, there was a massive drop of just over 83% in the number of certificates withdrawn from device companies by members of the TEAM-NB notified body association.

A total of 1,043 certificates were withdrawn in 2017 by members of TEAM-NB, who now number 24, according to the eighth annual survey of the association. This was down from 1,881 in 2016, which had been a substantial hike in the number of certificates withdrawn for the third year running.

Françoise Schlemmer, director of TEAM-NB, said the association has no explanation for the sudden drop in the number of certificates withdrawn. She suggested that it may be down to manufacturers now meeting the requirements of documents that have been introduced over the past several years and which better explain the requirements of the current device directives.

Schlemmer cited the September 2013 European Commission implementing regulation on the designation and supervision of notified bodies and the recommendation on notified body audits, which introduced tighter requirements that have been steadily filtering down to the manufacturer level. She also pointed to the updated clinical requirements in the revised clinical data guidance document, Meddev 2.7.1 revision 4, which are now better understood and applied by companies and notified bodies alike.

Figure 1

Certificates Withdrawn By Team-NB Members, 2013-2017

The number of certificates withdrawn by TEAM-NB notified bodies in 2017 would represent an average of 43.5 certificates withdrawn  by each member, compared with an average of 90 per member in 2016. Reasons why certificates may have been withdrawn include:

  • Suspension
  • Location closure
  • Company reorganization
  • Voluntary cancellation
  • Requirements not met
  • Failure to close non-conformities
  • Ceasing manufacture
  • Negative audit result
  • Financial issues
  • Audit review not performed
  • Notified body too expensive
  • Changes to product classification
  • Notified body change

When it comes to the distribution of CE marking certificates issued in 2017 between the different directives, a total of 90% were issued under the Medical Devices Directive (MDD), 7% under the IVD Directive (IVDD), and just 3% under the Active Implantable Medical Devices Directive (AIMDD).

Downturn In New Certificates Continues

The number of new CE marking certificates issued in 2017 by TEAM-NB members totaled 3,847, or an average of 160 per member among the 24 notified bodies.

Figure 2, below, reflects the downward trend in new certificates over the past five years. But TEAM-NB said it is currently unable to explain this trend. Medtech Insight notes that it may reflect a downward trend in companies CE marking their products under the medical device directives as firms prepare to apply for auditing by notified bodies under the new Medical Device and IVD Regulations (MDR and IVDR).

Extension Derogation

In theory, between May 26, 2020 and May 27, 2024, under the MDR, and May 26, 2022 and May 27, 2024, under the IVDR, companies which meet certain conditions and whose products are certified against the current directives may continue to place these CE-marked products on the market.

It may also result from companies that wish to continue to CE mark products under the directives holding out for the latest possible opportunity, i.e., close to the dates of application for the MDR (May 26, 2020) and IVDR (May 26, 2022) so that the can benefit from the extension derogation specified in the new regulations. Of course, not all companies can make use of this extension derogation. (Also see “What We Know About Notified Body Appointments: Useful Insights Into Timings And Capacity ” – Medtech Insight, 26 Feb, 2018.)

Also, while notified bodies have been substantially increasing staffing, many of the new recruits are still in training, and may not be sufficiently up to speed to offer full services yet.

There may also be the question, Medtech Insight notes, of whether some notified bodies might be conducting some kind of pilot audits or other services for medical device companies during this transition period for the MDR and IVDR. While the general consensus seems to be that pilot audits are not permitted under EU law, some notified bodies have been talking about creative solutions to help themselves get up to speed with the new regulations and help companies prepare.

Figure 2

New CE Marking Certificates Issued By Team-NB Notified Bodies, 2013-2017

Stabilization In Total Number Of Certificates

Meanwhile, the total number of CE marking certificates issued from 2010 to 2017 that are valid at any one time (EC certificates have a five-year validity period) has stabilized when compared to 2016. There was a small decline, however, in the number of ISO 13485 certificates issued last year, but this is after a three-year rise.

Figure 3

Total Valid Certificates, CE Mark and ISO 13485, 2013-2017

TEAM-NB says that the number of ISO 13485 certificates has declined by 4% in total and by 16% in relative figures. Nevertheless, the number of ISO 13485 certificates remains at a higher level than the CE certificates, the group says, because, apart from the manufacturers, there are also suppliers and/or distributors who require an ISO 13485 certificate.

Interestingly, among those holding certificates from TEAM-NB members, a total of 29% of those certificates are against EU regulations, and 71% against regulations outside the EU.

TEAM-NB Member Stats

The number of organizations that are members of TEAM-NB rose again in 2017 to 24. That is welcome news for device companies as the pressure builds for auditing services in advances of the 2020 and 2022 full-application dates for the MDR and IVDR .

Between 2013 and 2016, the number of TEAM-NB notified body members had dropped from 28 to 21. But this was counterbalanced by the number of full-time employees growing by 87% during the same time frame. This year has seen even further employee growth.

It is worth bearing in mind, however, that while notified bodies are hiring aggressively, it takes about a year to train a new auditor.

Since 2010, the number of full-time equivalent staff working at TEAM-NB notified bodies has more than doubled, according to figures included in the eighth annual survey. In 2017 alone, the total number of member employees rose by 20% to 2,183, while the number of contractors remained at 623.

This reflects in-house investment during a highly demanding time as notified bodies have been working toward designation under the MDR and IVDR, while also addressing the fall-out of the much tougher notified body requirements that were introduced in 2013 by the European Commission.

Figure 4

Full-Time Equivalents At TEAM-NB Members, 2013-2017

Interestingly, the number of full-time-equivalent external contractors has remained relatively even since 2013.

The growth in staff has been most marked among medium-sized notified bodies, where there has been a 23% increase in personnel, compared with an increase of 15% among the “big” notified bodies and a 21% rise among the small notified bodies.

Notified Body Size % Of All Notified Bodies # Of Certificates Delivered
Big 25 Over 1,000
Medium 17 350-1,000
Small 58 Up to 350

In terms of preparing for the future under the MDR and IVDR, a total of 80% of TEAM-NB’s members submitted their applications for designation against the new regulations in 2017, and “others planned to do so at the beginning of 2018.”

TEAM-NB’s Schlemmer said that the group plans to conduct a new survey in a couple of months. Its goal is to be as transparent as possible in the designation process; more more details should hopefully be available in July, she noted.

TEAM NB’s Turkish members have informed the notified body association that the transposition of the MDR is on-going in Turkey and they are preparing to apply for designation as soon as possible.Turkey intends to match the rest of the EU in fully applying the MDR on May 26, 2020.

Author: Amanda Maxwell  |  Source of Original Article

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