Obelis SA Obelis European Authorized Representative Center

Transatlantic Trade and Investment Partnership

According to recent reports, it appears clear that the future Transatlantic Trade and Investment Partnership (TTIP) between the European Union and the United States will most likely entail a higher level of reciprocal recognition and an easier circulation of Medical Devices between the two sides of the Atlantic.

Following the conclusion of the 6th and 7th rounds of negotiations, held respectively in July 2014 and October 2014, it seems clear that both, the European Union and the United States are eager to work towards recognising each other’s procedures for the approval and control of Medical Devices and to improve their cooperation in this area.

How cooperation and recognition should be ensured?

The reciprocal recognition of the respective systems should be ensured trough three main mechanisms:
•Unique Device Identification System (UDI)

The Compatibility between the EU and US UDI’s database – whose aim is to ensure identification and traceability of MDDs – should be ensured and enhanced.
•Regulatory Product Submission

The TTIP should allow streamliningthe compliance processes for Medical Devices in EU and US, through common application forms and simultaneous approval processes.
•Medical Devices Single Audit Programme

The International Medical Device Regulators Forum should develop a standard set of requirements for auditing the MDD Manufacturers. Moreover, mutual recognition of the QMS audits should be ensured.

The TTIP does not aim at harmonizing the different approaches for the approval of a medical device in EU and US; however there is a strong will to avoid duplication and/or overlaps of controls and tests in order to avoid extra-costs for public health systems and delays in making new devices available for patients.

Potential Outcomes

The foreseen shape of the TTIP might entail benefits for both public and industry. These will include:
•Faster access to life-saving devices;
•Better procedures for monitoring products and recallingthem when necessary;
•Reduced costs and burdens for trade of Medical Devices on the two sides of the Atlantic;

Obelis European Authorized Representative Centrecan ensure the highest level of advisory knowledge and expertise can provide a wide range of services aimed at developing full solutions for the introduction of Medical Devices in the European Market.

If you would like to know more on the ongoing negotiations and the potential outcomes of the Transatlantic Trade and Investment Partnership contact us