Fundamentals of the European devices regulatory framework

By Daniela Drago and Agung Purnama2019-10-01T15:14:00

In the EU, the development of medical devices is supported by the European Commission Directive (93/42/EEC Medical Devices Directive). To this, the EU has a unique system in dealing with medical devices, iconised as the CE Marking, which provides the right for the products to be commercialised in the EU. This continuing professional development supplement presents the unique system of medical devices that is currently applied in the EU. Additionally, the new regulation of medical devices (EU 2017/745 Medical Device Regulation) is also covered.

How to read this article

Thank you for visiting Regulatory Rapporteur, you have now used up your content views.

To continue reading:

If you are a TOPRA member, or have already registered for limited free access, log in now (Option 1 below).

Not yet a member? You can either join TOPRA (Option 2 below), or register to view limited content for free (Option 3 below).

1. LOGIN

Already a TOPRA member?

Log-in now using your MyTOPRA credentials, for unlimited access to all Regulatory Rapporteur journal articles, the online archive and latest industry news and podcasts.

Already registered for free content?

If you are not a TOPRA member but have already created an account to access limited free content, log-in here using your registered user email and password.

2. JOIN TOPRA

Interested in TOPRA membership?

Become a TOPRA member and join our global regulatory affairs community.

Great savings on our events and training.
Be part of our dynamic international community.
Contribute to the profession.
Grow your skills and knowledge.
Take your career to the next level.

Become a member

3. REGISTER FOR FREE

Want free access to selected content?

Register now to continue to access industry news, editorials and podcasts plus one member-only journal article each month.

Create your own library to save your favourite content.

Create a free account