Evidence map›Paper›PMID 38891189›Full record

ArticleHealthcare (Basel, Switzerland)2024

Core Legal Challenges for Medical 3D Printing in the EU.

Ante B V Pettersson, Rosa Maria Ballardini, Marc Mimler, Phoebe Li, Mika Salmi, Timo Minssen, Ian Gibson, Antti Mäkitie

Abstract read
In one paragraph

Article in Healthcare (Basel, Switzerland), 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

10 citing papers in PubMed.

  1. Review
  2. Article
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

8 authors.

Ante B V PetterssonDepartment of Otorhinolaryngology-Head and Neck Surgery, University of Helsinki and Helsinki University Hospital, FI-00029 HUS, Helsinki, Finland.ORCID 0000-0003-3262-2990
Rosa Maria BallardiniFaculty of Law, University of Lapland, 96399 Rovaniemi, Finland.ORCID 0000-0002-7662-9281
Marc MimlerThe City Law School, City, University of London, London EC1V 0HB, UK.ORCID 0000-0002-9457-2506
Phoebe LiSussex Law School, University of Sussex, Brighton BN1 9RH, UK.ORCID 0000-0001-9171-1729
Mika SalmiDepartment of Mechanical Engineering, Aalto University, 02150 Espoo, Finland.ORCID 0000-0002-7295-3551
Timo MinssenCenter for Advanced Studies in Bioscience Innovation Law (CeBIL), Faculty of Law, University of Copenhagen, 1172 Copenhagen, Denmark.ORCID 0000-0002-3286-4888
Ian GibsonDepartment of Design, Production and Management, University of Twente, 7522 NB Enschede, The Netherlands.ORCID 0000-0002-4149-9122
Antti MäkitieDepartment of Otorhinolaryngology-Head and Neck Surgery, University of Helsinki and Helsinki University Hospital, FI-00029 HUS, Helsinki, Finland.ORCID 0000-0002-0451-2404

Funding

the Novo Nordisk Foundation for an International Collaborative Bioscience Innovation & Law Programme (Inter-CeBIL Pro-gramme) NNF23SA0087056
6 · The paper itself

Abstract

3D printing has been adopted into routine use for certain medical applications, but more widespread usage has been hindered by, among other things, unclear legislation. We performed an analysis, using legal doctrinal study and legal informatics, of relevant EU legislation and case law in four issues relevant to medical 3D printing (excluding bioprinting or pharmacoprinting): pre-market approval, post-market liability, intellectual property rights, and data protection. Several gaps and uncertainties in the current legislation and interpretations were identified. In particular, we regard the current EU regulatory framework to be quite limiting and inflexible, exemplifying a cautionary approach common in EU law. Though the need to establish high safety standards in order to protect patients as a disadvantaged population is understood, both legal uncertainties and overregulation are seen as harmful to innovation. Hence, more adaptive legislation is called for to ensure continuous innovation efforts and enhanced patient outcomes.

Indexed as

3D printingadditive manufacturinglegal issueslegislationmedicalmedicineregulation

Identifiers

PMID38891189
PMCPMC11171897

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.