EU MDR | IVDR
ÅKRN provides guidance on how to navigate the regulatory landscape in Europe and how to set up a successful product development program.
The 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.
There are many commonalities between the FDA system in the USA and the system introduced by the European Commission in Europe, but there are also some important differences to be mindful of. That is why it is so important to be aware of all compliance-related issues relevant to your product.
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 the 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.
AKRN partners with MedTech companies as a scientific and regulatory consultant to ensure that we have a comprehensive understanding of the relevant information that will be required to prepare the essential documents.
AKRN partners to support MedTech companies in this process through the following CE Mark Regulatory Strategy Services:
- CE Mark Strategy
- Development of Intended Purpose and Product Labels
- Development of Technical Documentation
- EU Declaration of Conformity
- MDD to MDR Transition
- MDR Product Approval Requirements
- MDR GSPR Overview
- Product Classification Rules
- Registration of Devices
- Clinical Evaluation and Clinical Investigations
- Clinical Evaluation Report (CER)
- Notified Body Requirements
- Registration of Economic Operators and UDI
