Michael Barbella, Managing Editor11.22.23
Keep Cool About the Rule.
That is the advice Helena Holma is offering to startups and rookie entrepreneurs intimidated by the new Medical Device Regulation (MDR). “If you are a startup within healthtech—embrace the regulations,” Holma wrote in an early January blog. “There is no way around them and even if they may seem discouraging, remember they are for a good cause—to ensure patient safety and privacy. If you are well familiar with the regulations and include them in your business strategy, it will give you a competitive advantage.”
Perhaps, but MDR compliance is actually more of a necessity these days as Europe transitions to its long-awaited, much-debated, widely-hated medical device certification rules. Implemented in May 2017, European lawmakers drafted the MDR to update the continent’s archaic Medical Device Directive and harmonize the regulatory review and product approval process across all EU member states.
Although the medtech industry lauded the modernized rules—hopeful they would foster more patient-oriented innovation and better support the specific needs of small and medium-sized enterprises—manufacturers took issue with the MDR’s final compliance deadline, contending the three-year window was “unrealistic” and would lead to widespread device shortages. Calls for a deadline extension intensified as the May 26, 2020, due date approached, though the industry received an unexpected (but nevertheless welcome) one-year reprieve courtesy of COVID-19.
Since then, a growing chorus of industry groups and medtech firms have clamored for an extension to the MDR’s May 26, 2024, re-certification deadline, citing massive Notified Body backlogs and protracted reauthorization waits. As of March (2023), those waits averaged anywhere from six to 23 months (for QMS+product certification applications), while authorization requests nearly doubled, going from 6,188 in April 2022 to 11,418 in March 2023, European Commission survey data indicate.
And while certifications more than doubled in that time (1,069 to 2,951), more than 17,000 certifications were still set to expire next May (as of October 2022), including certificates under both the Medical Devices Directive (MDD) and Active Implantable Medical Devices Directive, according to survey results.
Faced with such a staggering certification logjam, the European Commission in January proposed new MDR deadlines, staggering final compliance dates through 2028 based on device risk classification. The proposal also allows products marketed under the MDD to remain, under certain conditions.
Approved by the European Parliament and Council over the winter, the new deadlines extend transition timelines to May 26, 2026, for Class III custom-made implantable devices; Dec. 31, 2027, for higher-risk (mostly) Class III devices and some Class IIb implantables; and Dec. 31, 2028, for medium-risk devices, including Class II products.
“Our rules on medical devices will always prioritise patient safety and support for innovation. A combination of factors has left healthcare systems across the EU facing a risk of shortages of life-saving medical devices for patients,” EU Health and Food Safety Commissioner Stella Kyriakides said in prepared remarks. “...we propose a revised regulatory timeline to provide certainty to industry in order to continue producing essential medical devices, reducing any short-term risk of shortages, and safeguarding access for patients most in need. Member States and notified bodies should work with industry to ensure transition to the new rules provided for by the Medical Devices Regulation, without further delay.”
Sound advice, certainly, but not so sound (or realistic) of a game plan.
Clearly, the deadline extensions give medtech manufacturers and Notified Bodies more time to complete conformity assessments. But the extensions alone will not guarantee regulatory compliance because they fail to resolve the MDR’s other challenges.
Perhaps the most vexing issue that remains unsolved is the inadequate Notified Body (NB) capacity. Thirty-nine NBs currently are authorized to process MDR and IVDR (In Vitro Diagnostic Medical Device Regulation) certification requests but applicants contend that total is insufficient to handle the backlog in a timely manner. NBs, however, claim such criticism is unjustified, noting they have invested in additional staff, training, and infrastructure to manage the caseload increase.
“...notified bodies have invested extensive time and resources to expand their capacity. They have hired a considerable number of additional staff members,” the European Association of Medical Devices Notified Bodies (TEAM-NB) argued in an early August (2023) whitepaper. “Furthermore, notified bodies have actively engaged in training their existing and new personnel to ensure they possess the necessary knowledge and competence to carry out conformity assessments and certifications under the MDR. They have also enhanced their internal processes, expertise, and infrastructure to align with the new regulatory framework.”
Besides defending its capacity improvement efforts, TEAM-NB outlined a strategy in the whitepaper for further easing Notified Bodies’ workloads and expediting MDR certifications. The group suggests:
“Timely and effective coordination between all stakeholders is paramount to prevent the challenges posed by potential peaks in demand for notified body capacity around the new deadlines set by the amending regulation,” TEAM-NB concluded in its whitepaper. “Notified bodies consider the amended timelines could imply great benefits for European patients as they could ensure continued availability of essential medical devices...However, to materialize these benefits, coordinated actions of authorities, manufacturers, and notified bodies are necessary.”
Indeed, administrative coordination is crucial for MDR’s successful implementation, but it’s only one facet of the many reforms European trade groups claim is needed to prevent treatment delays amid the new rules’ transition. MedTech Europe is calling for “comprehensive” changes to the MDR and IVDR framework to ensure both current and future medical advancements reach European patients and health systems.
In an open letter to Kyriakides, MedTech Europe said the continent’s new device and diagnostics rules have not achieved their intended objectives because their structures are “unpredictable, complex, slow, and costly.”
“It is apparent there are structural issues in the regulatory framework which cannot be solved simply through its implementation,” read the Sept. 14 letter, signed by 34 national trade groups. “Reaching the objectives of the IVDR and MDR in full will require comprehensive change to improve efficiency, support innovation, and strengthen governance...”
In the letter, the trade groups propose changing the CE marking system under the MDR to make it more efficient and reduce the administrative burden. They also recommend creating an “innovation principle” that quickly connects the latest medical technologies to European patients and health systems through dedicated, fast-track assessment pathways and early dialogues with developers. The groups’ final suggestion is establishment of a single, dedicated structure to oversee the regulatory system, including NB designation and oversight.
“Only together can we deliver on the original goals of the IVDR and MDR to develop an effective and fit-for-purpose regulatory system for the benefit of European patients, health systems, and society,” the letter concluded.
Bureaucracy be damned.
Read more: bit.ly/3F3kiCP
Check out more of ODT’s 2023 year in review:
EtO Gets a Clean Start
Ortho’s Mega-M&A Is MIA
Artificially Intelligent Orthopedics
That is the advice Helena Holma is offering to startups and rookie entrepreneurs intimidated by the new Medical Device Regulation (MDR). “If you are a startup within healthtech—embrace the regulations,” Holma wrote in an early January blog. “There is no way around them and even if they may seem discouraging, remember they are for a good cause—to ensure patient safety and privacy. If you are well familiar with the regulations and include them in your business strategy, it will give you a competitive advantage.”
Perhaps, but MDR compliance is actually more of a necessity these days as Europe transitions to its long-awaited, much-debated, widely-hated medical device certification rules. Implemented in May 2017, European lawmakers drafted the MDR to update the continent’s archaic Medical Device Directive and harmonize the regulatory review and product approval process across all EU member states.
Although the medtech industry lauded the modernized rules—hopeful they would foster more patient-oriented innovation and better support the specific needs of small and medium-sized enterprises—manufacturers took issue with the MDR’s final compliance deadline, contending the three-year window was “unrealistic” and would lead to widespread device shortages. Calls for a deadline extension intensified as the May 26, 2020, due date approached, though the industry received an unexpected (but nevertheless welcome) one-year reprieve courtesy of COVID-19.
Since then, a growing chorus of industry groups and medtech firms have clamored for an extension to the MDR’s May 26, 2024, re-certification deadline, citing massive Notified Body backlogs and protracted reauthorization waits. As of March (2023), those waits averaged anywhere from six to 23 months (for QMS+product certification applications), while authorization requests nearly doubled, going from 6,188 in April 2022 to 11,418 in March 2023, European Commission survey data indicate.
And while certifications more than doubled in that time (1,069 to 2,951), more than 17,000 certifications were still set to expire next May (as of October 2022), including certificates under both the Medical Devices Directive (MDD) and Active Implantable Medical Devices Directive, according to survey results.
Faced with such a staggering certification logjam, the European Commission in January proposed new MDR deadlines, staggering final compliance dates through 2028 based on device risk classification. The proposal also allows products marketed under the MDD to remain, under certain conditions.
Approved by the European Parliament and Council over the winter, the new deadlines extend transition timelines to May 26, 2026, for Class III custom-made implantable devices; Dec. 31, 2027, for higher-risk (mostly) Class III devices and some Class IIb implantables; and Dec. 31, 2028, for medium-risk devices, including Class II products.
“Our rules on medical devices will always prioritise patient safety and support for innovation. A combination of factors has left healthcare systems across the EU facing a risk of shortages of life-saving medical devices for patients,” EU Health and Food Safety Commissioner Stella Kyriakides said in prepared remarks. “...we propose a revised regulatory timeline to provide certainty to industry in order to continue producing essential medical devices, reducing any short-term risk of shortages, and safeguarding access for patients most in need. Member States and notified bodies should work with industry to ensure transition to the new rules provided for by the Medical Devices Regulation, without further delay.”
Sound advice, certainly, but not so sound (or realistic) of a game plan.
Clearly, the deadline extensions give medtech manufacturers and Notified Bodies more time to complete conformity assessments. But the extensions alone will not guarantee regulatory compliance because they fail to resolve the MDR’s other challenges.
Perhaps the most vexing issue that remains unsolved is the inadequate Notified Body (NB) capacity. Thirty-nine NBs currently are authorized to process MDR and IVDR (In Vitro Diagnostic Medical Device Regulation) certification requests but applicants contend that total is insufficient to handle the backlog in a timely manner. NBs, however, claim such criticism is unjustified, noting they have invested in additional staff, training, and infrastructure to manage the caseload increase.
“...notified bodies have invested extensive time and resources to expand their capacity. They have hired a considerable number of additional staff members,” the European Association of Medical Devices Notified Bodies (TEAM-NB) argued in an early August (2023) whitepaper. “Furthermore, notified bodies have actively engaged in training their existing and new personnel to ensure they possess the necessary knowledge and competence to carry out conformity assessments and certifications under the MDR. They have also enhanced their internal processes, expertise, and infrastructure to align with the new regulatory framework.”
Besides defending its capacity improvement efforts, TEAM-NB outlined a strategy in the whitepaper for further easing Notified Bodies’ workloads and expediting MDR certifications. The group suggests:
- Making better use of hybrid audits, and combining audits under the directives and regulations for legacy products;
- Abandoning technical documentation sampling for MDR devices;
- Promptly adding designation codes to NBs;
- Improving dialogue between regulators and stakeholders;
- Reducing NB designation timelines;
- Developing alternative competency demonstration methods;
- Harmonizing procedures and enhancing predictability; and
- Increasing complete (and timely) MDR applications.
“Timely and effective coordination between all stakeholders is paramount to prevent the challenges posed by potential peaks in demand for notified body capacity around the new deadlines set by the amending regulation,” TEAM-NB concluded in its whitepaper. “Notified bodies consider the amended timelines could imply great benefits for European patients as they could ensure continued availability of essential medical devices...However, to materialize these benefits, coordinated actions of authorities, manufacturers, and notified bodies are necessary.”
Indeed, administrative coordination is crucial for MDR’s successful implementation, but it’s only one facet of the many reforms European trade groups claim is needed to prevent treatment delays amid the new rules’ transition. MedTech Europe is calling for “comprehensive” changes to the MDR and IVDR framework to ensure both current and future medical advancements reach European patients and health systems.
In an open letter to Kyriakides, MedTech Europe said the continent’s new device and diagnostics rules have not achieved their intended objectives because their structures are “unpredictable, complex, slow, and costly.”
“It is apparent there are structural issues in the regulatory framework which cannot be solved simply through its implementation,” read the Sept. 14 letter, signed by 34 national trade groups. “Reaching the objectives of the IVDR and MDR in full will require comprehensive change to improve efficiency, support innovation, and strengthen governance...”
In the letter, the trade groups propose changing the CE marking system under the MDR to make it more efficient and reduce the administrative burden. They also recommend creating an “innovation principle” that quickly connects the latest medical technologies to European patients and health systems through dedicated, fast-track assessment pathways and early dialogues with developers. The groups’ final suggestion is establishment of a single, dedicated structure to oversee the regulatory system, including NB designation and oversight.
“Only together can we deliver on the original goals of the IVDR and MDR to develop an effective and fit-for-purpose regulatory system for the benefit of European patients, health systems, and society,” the letter concluded.
Bureaucracy be damned.
Read more: bit.ly/3F3kiCP
Check out more of ODT’s 2023 year in review:
EtO Gets a Clean Start
Ortho’s Mega-M&A Is MIA
Artificially Intelligent Orthopedics