By Oliver P Christ
The implementation of the new European Medical Devices Regulation (MDR) and In Vitro Diagnostic Medical Devices Regulation (IVDR) has reached a critical momentum.
With only 20 months left in the transition period for MDR, medical device manufacturers that want to place medical devices on the EU market after 26 May 2020 are working diligently to implement the new regulatory requirements.
When it comes to budgeting and planning for additional regulatory resources, many manufacturers are still in gap analysis mode. The five hottest topics to meet compliance with MDR are:
- Clinical investigation and evaluation
- New roles and responsibilities for “economic operators”
- Postmarket surveillance and vigilance, and market surveillance
- Risk management and usability engineering/ design input
- Overhaul of labeling and technical documentation
The first notified bodies under MDR notification are expected to operate by the second quarter of 2019, one year before the end of the transition period.
Compliance audits for MDR need to be prepared using ISO 13485:2016 as a basis for a compliant quality management system by adding in-depth processes required by MDR (e.g. for clinical investigation, postmarket surveillance, etc). The new MDR Annexes II and III contain more detailed requirements for technical documentation for all classes of medical devices.
Now is the time to update “old” medical devices directive technical files to the new MDR requirements in Annex I (General Safety and Performance Requirements). The graphic above shows the estimated costs of implementing the new regulation.
When companies do not have enough resources available in-house to do this job, external resources such as technical file development may be employed to manage the regulatory road map for success.
Waiting is no longer an option. If you need assistance with this work, please contact firstname.lastname@example.org.
About the author
Oliver Christ has been active in international standardization efforts for more than 25 years and co-founded PROSYSTEM with the late Dr Jürgen Stettin in 1999.
The company was acquired by NSF International in 2017. In Germany, Mr Christ has served as chair or co-chair of national committees including Human Factors/Usability for Medical Devices, Risk-Management for Medical Electrical Equipment, and Software for Medical Devices and Networked Medical Systems.
Mr Christ represents Germany on international standard committees for programmable electrical medical systems, human factors, risk management, software lifecycle processes, and risk management for IT-networks incorporating medical devices (published as IEC 80001-1:2010).
In 2013, Mr Christ became an international delegate for Germany for the AAMI/UL initiative UL 2800 on Interoperability for Medical Devices. He received the DKE Needle award in 2014.