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interact with active ingredients, and
4. Other applications such as diagnostics, product mold components, scanning
technology, and bone cement mixers for orthopedic procedures [97, 98].
The rapid application of this new material family is an indication of
the need for materials with improved performance. New product delivery
methods, such as the medication straw, are also needed to safely deliver new
biologics and pharmaceuticals. Innovations and the operational develop-
ments such as these are necessary to provide safe and effective packaging
systems for the increasingly complex combination products [19, 21, 98].
Developments on the technology will not be successful or will be ad-
opted slowly if the regulatory processes do not keep pace. New regulations
are increasing the requirements resulting in increased efforts to comply.
Regulatory authorities are simultaneously promoting new initiatives to al-
low patients to have faster access to new innovative devices, while con-
taining or reducing health-care cost. The US FDA CDRH has launched
its regulatory science development priorities for improved and faster reg-
ulatory decision making in 2017. It includes areas like the modernization
of biocompatibility and biological risk evaluation of device materials and
reducing Healthcare Associated Infections (HAIs) by better understanding
the effectiveness of antimicrobials, sterilization, and reprocessing of medical
devices. The idea is also to work collaboratively with external stakeholders
to maximize the impact of regulatory science research investments. Science
clearly plays a key role, but so do standards. State-of-the-art global con-
sensus standards enhance competition and allow leveraging of regulatory
efforts over various regions. Participation of authorities in standard devel-
opment is also essential. While the US FDA and the authorities of Japan,
Canada, Australia, and Brazil are present in key standardization committees,
the EU authority’s participation recently did not reflect the relative size of
the economy. The 2012 EU regulation on European standardization [99]
clearly encourages European authorities to participate in TCs as an essen-
tial activity required for successful collaboration with industry stakehold-
ers. The new EU MDR [18] continues to build on the “New Legislative
Framework” concept based on “harmonized” standards which provide pre-
sumption of conformity with essential elements of the law. Harmonization
of revised and of new standards, however, has been lagging even under the
medical device directives. To prepare for the transition to the new regula-
tory regime and to improve the situation of harmonized standards, the EU
Commission introduced in 2018 a new system with harmonized standards
consultants to be involved in the standardization process. The new MDRs