FDA vs. EU compliance under the new Medical Device Regulation
The recently adopted Medical Device Regulation 2017/745, set as an amendment to EU Directive 93/42/EEC, laid out some essential health and safety requirements as regards compliance paths for manufacturers with medical devices looking to enter the European Market. Regulations and directives like these create Harmonized Standards which ensure all products in a given market place are safe for consumer use. However, as one passes from one market place to another, they might find that some paths of product compliance may vary. In this blog, we are going to outline some of the main points introduced by MDR 2017/745 to help explain some of the commonalities and differences between the FDA system in the USA and the system introduced by the European Commission in Europe in an effort to point out how some compliance paths may vary from region to region, and as a result, why it is so important to be aware of all compliance related issues relevant to your product.
In the past, due to the relative requirements and processes in place in each area, it has been the conception that it is better for products to enter the European market before entering the US market. This is due to the fact that, historically, the US market entry process is one that takes markedly more time on account of the FDA approval process. This is in contrast to the European process in which products could be brought to the market with relative ease as non-compliance issues were a matter of notification, rather than pre-approval. Therefore, the general belief has been that it takes less time to bring a product to the EU market than the US market. This previous EU process however, under MDR 2017/745 has been changed slightly, and that relative ease of entry is no longer necessarily the case.
One major factor introduced in MDR 2017/745 that may impact the timeframe for EU market entry is the requirement for each product to have a Unique Device Identifier (UDI). This is a factor now common to both the EU and the US. The UDI system was first introduced in the US in 2007 in an effort to create greater market transparency and facilitate an efficient market surveillance system. It also reduced the potential number of errors or malfunctions of devices on the market making them safer for both patient and the user.
The second important factor is the increased importance and heightened accessibility to the EUDAMED system. Under MDR 2017/745, EUDAMED (the European Database on Medical Devices) is now available to each EU member state, the European Commission, relevant Notified Bodies, economic operators, sponsors, and members of the public – rather than just the EU Commission and the relevant Competent Authorities as was the case previously. The objective of this, as with the introduction of mandatory UDIs, is greater transparency in the EU market. With this increased openness, the EUDAMED database itself has also been widened to include:
- Unique Device Identification database
- Registration of economic operators
- Registration of devices
- Notified Bodies accreditation (replacing Nando)
- Performance studies
- Vigilance and post-market surveillance
- Compatibility with national databases allowing for the import and export of information
The result of these new introductions under MDR 2017/745 is that manufacturers and distributors may face an increased entry time to the European market. However, it is important to note that each market should always be entered on its own merits, paying close attention to its individual guidelines and regulations, and that entering one market due to restrictions on another without forethought can lead to many issues in the long term.
For more information on the compliance path for your medical devices under Regulation 2017/745, how to create a UDI for your device, to find out about our Authorized Representative or CE Marking services, or to get advice from our team of regulatory and legislative experts, contact us today.