Medical devices

Medical devices regulations in Europe differ from regulations for medicinal products and from the relevant regulations in other jurisdictions, e.g. the USA. With a CE mark, a device can be marketed in the European Union, in the countries of the European Free Trade Association and in Turkey.

Services:

  • Clinical investigations applications to competent authorities
  • Ethics Committee submissions for clinical investigations of medical devices
  • Clinical evaluations of medical devices to obtain the CE mark
  • Guidance on medical device classification
  • Interaction with and dossier preparation for Notified Body in Europe
  • Consulting on the European Medical Devices Directives
  • Medical Device vigilance for adverse events during clinical investigations

Clinical studies in medical devices*

therapeutic area

phase

studies

sites

subjects

countries

Cardiovascular medicine
pre- and post-marketing
26
134
2457
Dermatology
pre-marketing, device / drug combination
3
7
56
Gastrointestinal medicine
post-marketing
1
1
30
Diabetes
pre-marketing
6
8
148
Diabetes, CVS Pain, Parkinson, Ophthalmology
device, medical writing
13
n.a
n.a
ENT (ear, nose, throat)
pre-marketing
1
2
30
GCP-Trainings (devices)
n.a
3
n.a
n.a
Gynecology
pre-marketing
3
7
226
Nephrology
pre-marketing
1
3
20
Neurology
Device / Drug combination phase IIb
1
6
89
Oncology
pre- and post-marketing
2
4
40
Ophthalmology: ocular diagnostic devises / surgical devices
pre-marketing
9
32
447
Orthopedic
pre-marketing and post- marketing
5
7
227
Pain therapy
device, clinical investigation
1
3
45
Consulting Regulatory: Regulatory Training
n.a
8
n.a
n.a
Consulting Clinical Investigation: Ophthalmology, ENT, Cardiology, Spine disease
various
5
n.a
n.a
CER Clinical evaluation report writing: Ophthalmology, Dermatology
n.a
6
n.a
n.a
Medical writing: Diabetes, CVS Pain, Parkinson, Dermatology, Ophthalmology
various
13
n.a
n.a

Total

81

214

3815

May, 2022

Ophthalmology

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Dermatology

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Pediatric procedures & investigations

In order to be able to treat children properly, the safety and efficiency of therapeu…

Regulatory Affairs

In today’s competitive environment the reduction of the time to market is important f…