June 2019 – New Medical Regulations

Less than a year for the implementation of EU MDR 2017/745 to go!

European database on medical devices (EUDAMED)

The European Commission has recently set up a new webpage to collect information that is related to the implementation of the upcoming European database on medical devices (EUDAMED). The website is expected to be updated regularly upon new implementation
documents are finalised.

Posted by MedTech Europa on 06.06.2019 Link:
https://www.medtecheurope.org/news-and-events/news/european-database-on-medical-devices-eudamed/

MedTech Europe’s position on the standardisation request for the IVD and MD Regulations

MedTech Europe has recently published its position on the European Commission Standardisation Request for the IVD and MD Regulations. MedTech Europe’s position paper aims at outlining several concerns including limited flexibility, resourcing and expected timing of the harmonisation process. The proposed process, as it stands now, is likely to be challenging for
stakeholders to effectively implement. Therefore, MedTech Europe calls upon Member States, Notified Bodies and National Standards Organisations to support the integrity of healthcare system by raising these concerns to the European Commission.

Posted by MedTech Europa on 06.06.2019 Link:
https://www.medtecheurope.org/news-and-events/news/medtech-europes-position-on-the-standardisation-request-for-the-ivd-and-md-regulations/

UK NB will not apply for EU MDR/IVDR

London-based Lloyd’s Register Quality Assurance (LRQA) announced Wednesday that it will withdraw from its notified body (NB) services under the EU’s current medical device and in vitro
diagnostic directives and will not apply to New Medical Regulations June 2019 be an NB under the new medical device and in vitro diagnostic regulations (MDR/IVDR).

“Following recent market developments and in the spirit of transparency, we have made the strategic business decision to exit from these services,” said LRQA customer experience director Claire Ruggiero.

LRQA directed clients to choose an alternative NB and establish a team to help with transition activities, with the goal of minimizing the risk of disruption. Citing the need to ease the transition,
LRQA said it is providing 90 days’ notice rather than the required 30 days.

Ruggiero clarified that LRQA will continue providing its third-party certification services relating to ISO 13485 and the International Medical Device Regulators Forum’s Medical Device Single Audit Program (MDSAP). And the company will still provide “medical devices-related training to clients both in the UK and worldwide,” she said.

The moves by LRQA add to the difficulties in implementing MDR and IVDR and the concerns that span across the EU sector, which may be nearing an anticipated “cliff-edge” scenario. The German and Irish delegation also just recently elevated ongoing concerns with NB capacity under MDR. BSI UK and TÜV SÜD are still the only NBs to be designated under MDR so far.

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) identified next steps for manufacturers based on LRQA’s decisions, explaining the urgency of transferring to an alternative NB. LRQA said its services will cease regardless of whether the transfers are completed within the 90-day notice period.

Other solutions to combat a lack of NBs have also circulated.

In a recent position paper on recommendations for the issues around NB readiness and availability, the European Coordination Committee of the Radiological, Electromedical and Healthcare IT Industry (COCIR) pointed to leveraging MDSAP certificates to help offset a potential lack of NBs under MDR.

Posted by Ana Mulero on 12.06.2019 Link:
https://www.raps.org/news-and-articles/news-articles/2019/6/uk-nb-will-not-apply-for-eu-mdrivdr

Two EU Competent Authorities call for review of MDR implementation status by year’s end

Two EU member states have waded into the argument about the likelihood of the system needed for the implementation of the new MDR being ready on time and believe “options for solutions” need to be considered.

Posted by Amanda Maxwell on 13.06.2019 Link:
https://medtech.pharmaintelligence.informa.com/MT125242/Two-EU-Competent-Authorities-Call-For-Review-Of-MDR-Implementation-Status-By-Years-End

Notified Body survey offers new data on EU medical device certificates

Findings from a recent survey of notified bodies (NBs) for medical devices and in vitro diagnostics (IVDs) indicate fluctuation in the numbers of certificates in 2018 versus prior years.

The European Association for Medical Devices of Notified Bodies-Team-NB-surveyed its 23 members at the end of 2018 and the results illustrate show how companies are preparing for the EU’s medical device and in vitro diagnostic regulations (MDR/IVDR).

Last year saw an increase of nearly 30% in the number of new certificates issued by member NBs- totalling 4,992 certificates—after four years of decline in these total numbers. This is “surely in line with the anticipation of industry in the renewal of their certificates against” the EU’s medical device directive “in order to avoid the uncertainties of the future,” said Team-NB.

MDR provides a grace period so certificates can remain valid through 2024, although that grace period does not apply to some classes of devices. Certificate renewals come in anticipation of an NB shortage under MDR as well.

There was a 6% decrease in the number of valid certificates at the end of 2018, with just 18,449 certificates in total versus 19,775 certificates at the end of 2017. The total number of withdrawn
certificates grew by 17% to 1,220 certificates in 2018, up from 1,043 certificates in total the year prior. Reasons NBs’ clients cited for withdrawing certificates include financial issues, an NB change and Brexit, among others.

The fluctuation in the number of valid and withdrawn certifications coincides with the impact of MDR/IVDR on product portfolios. But a lack of EU-wide coordination on device portfolios could create EU-wide supply bottlenecks amid the transition to MDR/IVDR.

Posted by Ana Mulero on 24.06.2019 Link:
https://www.raps.org/news-and-articles/news-articles/2019/6/notified-body-survey-offers-new-data-on-eu-medical

May 2020 MDR deadline is ‘Realistic and Achievable,’ EU Health Commissioner says

While acknowledging that the May 2020 deadline for the implementation of the new medical devices regulation (MDR) is a “significant challenge” the European Commissioner for Health and Food Safety said Friday that the industry and government “are on course to meet it.”

Vytenis Andriukaitis’s comments at a meeting of EU Ministers for Employment, Social Policy, Health and Consumer Affairs (EPSCO) in Luxemburg followed concerns raised this week by German and Irish delegations to the Council of the EU over notified body (NB) capacity and the implementation of MDR.

As far the “crucial issue” of NBs, Andriukaitis said 51 NB applications have been received by the EC as of Thursday, 29 joint assessments have been performed and the two biggest NBs have been designated (BSI and TÜV SÜD) and hold a significant share of the certificates.

Based on current information, the EC expects 20 NBs to be designated before the end of this year.

And although the number of NBs under the new regulations could be lower when compared to now Lloyd’s Register Quality Assurance (LRQA) said Wednesday that it will not apply to be an
NB under MDR/IVDR), Andriukaitis said: “This is not a surprise… Stricter requirements have been set to ensure that future notified bodies are fully fit for purpose. On the other hand, this will mean higher capacity in designated notified bodies.”

As far as progress achieved so far, Andriukaitis pointed to the preparation of the Eudamed database core modules, which will be functional in line with the deadlines, the establishment of the unique device identifier system and work on implementing acts, including one on expert panels, which he said is close to being finalized.

In terms of postponing the transition period, Andriukaitis said that “any change of rules at this late stage would be unfair to serious operators that have carried efforts to ensure their timely
compliance.”

“In conclusion, May 2020 is a realistic and achievable deadline… and the implementation process remains a shared responsibility among all partners, including member states, NBs and operators,” he added.

UK Response

In agreement with the concerns raised by Germany and Ireland, Nicola Blackwood, UK’s Parliamentary Under Secretary of State for Health (Lords), said Friday she’s also concerned about “the readiness of critical infrastructure,” noting “there’s an increasing likely risk that the system
won’t be ready” by next May.

She said the “principle concern” is that NBs will not be designated in time or have the capacity to deal with newly up classified devices in addition to their existing portfolios.

“This is likely to delay patient access to a large number of devices,” she added. “We will continue to work to ensure implementation in a timely manner… but we have to have plans in place to mitigate those risks” of implementation not meeting the May deadline.

Posted by Zachary Brennan on 14.06.2019 Link:
https://www.raps.org/news-and-articles/news-articles/2019/6/may-2020-mdr-deadline-is-realistic-and-achievable

Another Notified Body Bows Out Ahead of EU MDR: ‘Investment Too High’

Swiss notified body (NB) QS Zürich AG has decided that it will not pursue designation under the new EU medical devices regulation (MDR), although EN ISO 13485 support will remain.

Ursula Roesler, head of medical devices at QS Zürich AG, told Focus that the medical device department will be closed by the end of October. As far as why the decision was made, Roesler said, “It was a business decision of the CEO—the investment was too high for a small NB like QS Zürich AG.”

The company has worked as an accredited certification body for management systems and as an NB for medical devices in the EU since 1998.

The news from Switzerland follows a decision from London-based Lloyd’s Register Quality Assurance (LRQA) last week to withdraw its NB services under the EU’s current medical device and in vitro diagnostic directives and to not apply to be an NB under the new MDR or the in vitro diagnostic regulation (IVDR).

LRQA directed clients to choose an alternative NB and the firm established a team to help with transition activities, with the goal of minimizing the risk of disruption.

Similarly, the Spanish Agency of Medicines and Medical Products (AEMPS), the only Spanish NB, said in late May that it will no longer accept device applications from new clients for CE marking and cease to process new certificate applications from existing clients beginning 31 July 2019.

Despite the shifting landscape and as more NBs are expected to drop out, the European Commissioner for Health and Food Safety last Friday sought to reassure device companies that an extension to the May 2020 MDR deadline would not be necessary. Experts, however, have questioned the prediction that about 20 NBs will be designated before the end of 2019.

Only two NBs have been designated against MDR so far and none have been designated against IVDR. The European Commission noted on Monday that the wider scope of IVDR will result in about 85% of all IVDs being subject to NB oversight, up from 20% under the current directive.

Posted by Zachary Brennan on 18.06.2019 Link:
https://www.raps.org/news-and-articles/news-articles/2019/6/another-notified-body-bows-out-ahead-of-eu-mdr-i

EC Previews Call to Set up Expert Panels for EU MDR/IVDR

The European Commission (EC) said on Friday it will issue a call for applications to set up the expert panels for the premarket product evaluation consultation procedures provided under the EU’s medical device regulation (MDR) and in vitro diagnostic regulation (IVDR).

The EC is preparing to designate the new expert panels that will support the assessments for certain medical device classes and IVDs. The EU legislation obliges the EC to establish the expert
panels in consultation with the Medical Device Coordination Group (MDCG). With a new one-pager, the EC explains the role that the selected clinical and other experts will play in MDR/IVDR.

MDR and IVDR explain the consultation processes on clinical and performance evaluations that require the designated experts to respond to notified bodies (NBs) and manufacturers of class III implantable devices and class IIb active devices for administering and/or removing medicinal products, as well as class D IVDs. The selected experts will be appointed in several different medical fields. They may either be appointed for a renewable 3-year term or “included on a central list of available experts from which they may be called to support panels,” the EC says.

Not only will the selected experts contribute to assessments of high-risk devices prior to their CE marking, but also to the future improvement of the MDR/IVDR framework. Experts will advise the EC, the MDCG, EU member states and manufacturers to help improve upon the framework. They will be involved in “contributing to the development of common specifications for clinical evaluation of device categories, guidance documents or standards,” the EC notes.

MDR’s framework is already nearing its 26 May 2020 date of application, followed by that of IVDR on 26 May 2022. The MDCG said in a document the EC posted in March that clarification of a criterion under a provision relevant to setting up the expert panels—Article 54(2)b—is “extremely urgent notably due to its impact on the future workload of panels.” The document also reported the imminent launch of procedures to establish the expert panels.

The one-pager does not offer specifics for the when the EC will launch the call for experts this year. But the latest version of the EC’s rolling plan on MDR/IVDR essential implementing acts
and actions broadly set the target timeline for the expert panels’ establishment to Q3 2019.

Implementation delays were discussed at the EU Ministers for Employment, Social Policy, Health and Consumer Affairs (EPSCO) earlier this month, following concerns raised by German and Irish
delegations. Yet on the May 2020 MDR deadline, the European Commissioner for Health and Food Safety said that industry and government “are on course to meet it.”

Posted by Ana Mulero on 21.06.2019 Link:
https://www.raps.org/news-and-articles/news-articles/2019/6/ec-previews-call-to-set-up-expert-panels-for-eu-md

EU MDR: Germany and Ireland Express Concerns

German and Irish delegations to the Council of the European Union recently raised concerns with notified body (NB) capacity and the implementation of the EU’s medical device regulation (MDR).

Ahead of a 14 June Council session, the delegations explain how NB capacity “is the most imminent and high-profile challenge,” although requirements, infrastructure system and secondary legislation are additional challenges.

And although the European Commission remains steadfast in its commitment to designate enough NBs in time for MDR’s application date in May 2020, the delegations note that “there will still be significantly fewer” NBs available and there are no data on the capacity that those NBs “will afford the system.”

Only two NBs; BSI UK and TÜV SÜD have been designated against MDR so far and none under the in vitro diagnostic regulation (IVDR). The expectation is for less than 20 NBs to be MDR-designated by the end of this year, MedTech Europe reported.

CEO and founder of UK-based MedBoard Ivan Perez told Focus the hope is that Ireland and Germany will “bring more clarity to the situation soon.” He argues that “it will be very interesting to know the outcome and whether there will be further action.”

Yet Perez further argued that depending on the source, the information “is very contradictory, as the EC keeps saying that many NBs will be designated by end of 2019, but now the country delegations of two important” medical technology countries “raise concerns about capacity
and implementation too.”

The delegations also raised concerns about potential market shortages for some devices that will not be safeguarded under MDR’s grace period.

As for next steps, the Irish and German delegations call on member states to “immediately consider their state of preparedness” for MDR/IVDR implementation at the national level and at a European level and identify and discuss “specific and particular challenges…along with options for solutions to these challenges.” Member states, the EC and, if necessary, the European Parliament should hold further discussion on the matter by year’s end, they added.

The coordinating group established by MDR issued a Q&A last week on new obligations relating to NBs.

Posted by Ana Mulero on 11.06.2019 Link:
https://www.raps.org/news-and-articles/news-articles/2019/6/eu-mdr-germany-and-ireland-express-concerns

References
Image 1:
https://www.perficient.com/insights/guides/2018/2018-pharmaceutical-and-medical-device-industry-trends
Image 2:
https://www.tracoe.com/en/show/article/medical-device-regulation-mdr/
Image 3:
http://stopzet.org/2017/07/04/open-letter-the-european-commission/
Image 4:
https://www.med-technews.com/why-ip-needs-a-refresh-with-eu-medical-devices-regulations/