Search
Close this search box.
Logo Asphalion

WHITE PAPER | Impact of MDR on Directive 2001/83/EC: What you need to know

The Medical Device Regulation 2017/745 (MDR)1 has been out and about for almost four years after its entry into force in May 2017.

The Medical Device Regulation 2017/745 (MDR)1 has been out and about for almost four years after its entry into force in May 2017.
May 4, 2021

The Medical Device Regulation 2017/745 (MDR)1 has been out and about for almost four years after its entry into force in May 2017. This new legal framework has had a massive impact on the medical devices sector and, even though the different economic operators, notified bodies (NBs) and competent authorities had an extra year to get ready before it fully replaces the Medical Device Directive 93/42/EEC (MDD)2 (after the date of application was postponed due to the COVID-19 outbreak by means of Regulation (EU) 2020/5613), there are still lots of uncertainties regarding the implementation of several of its articles.

Asphalion’s Medical Devices Experts have developed a white paper which provides an overview of the impact of article 117 MDR will pose on Directive 2001/83/EC.

This White Paper is aimed at clarifying the principal points that should be taken into account by Pharmaceutical Companies with regard to their integral DDCs while preparing the MAA dossiers or maintaining the granted licenses during life-cycle management in Europe.

 

You can download this white paper here: WHITE PAPER | Impact of MDR on Directive 2001/83/EC 

 

Search News & Events

  • Filter by category

Share

Related news and events

NEWS | Proposed framework for International Recognition of Medical Devices by MHRA

This statement describes the draft policy for recognition by the UK of international regulators’ approvals of medical devices.
This statement and proposed framework applies to medical devices in Great Britain. For guidance on the regulation of devices in Northern Ireland, see Regulation of devices in Northern Ireland.

For further information

If you are interested in our services, or wish to get in touch for a general enquiry, please contact us for more information.

Fill the form and we will contact you as soon as possible.

You can also follow us on:

Schedule a Free Meeting

Schedule here a free 30-minutes meeting with one of our consultants and tell us about your project, challenges or doubts. 

We will be happy to assist you!

Schedule a meeting