The European Medical Device Regulations were published by the European parliament in April 2017. Like the EU Directive on Pharmaceuticals which preceded them, it means that any company supplying Medical Devices in the European Union (even those manufactured outside the EU) are legally obliged to comply or they are breaking the law. Yes, it’s very black and white.
The term medical device covers any "instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent or any other similar or related article, including a component part, or accessory" which accomplishes its function without "chemical action within or on the body of man or other animals and which is not…metabolized for the achievement of any of its primary intended purposes." (U.S. Food & Drug Administration. 2016)
The directive itself is almost 200 pages long and quite a difficult read. However, for anyone in this sector who is impacted, they really need to start working on it immediately if they haven’t already started. By May 2020, the data upload requirements must be in place, and to be compliant, there is a huge body of work to be done in terms of generating your product Master Data and determining how best to manage and upload it to the European Database of Medical Devices (EUDAMED).
Every time there is a change to the product and hence the product Master Data, the changes must be reported to EUDAMED. Long term it will create a body of work for all companies to remain compliant.
On the Production side, the requirements for Device Identification kick in for Class 111 devices in June 2021. In the pharmaceutical world, the concept of islands of manufacturing no longer really exists. All manufacturing and labelling data is controlled centrally and every manufacturing device is interconnected. This directive may well have the knock-on effect of speeding up the integration of the manufacturing process and the supply chain for Medical Devices. Data and Traceability are now becoming key.
While at the moment, the regulatory requirements do not include Aggregation or the creation of the child-parent, parent-grandchild relationships that are prevalent with pharmaceuticals, I believe this will become a commercial requirement for manufacturers in the years ahead, in spite of the added complexity and cost.
The Medical Device industry should leverage what has happened in the Pharmaceutical sector to date and the companies that have a successful track record in this area. While the Pharmaceutical and Medical Device fields are different, as is the FMD and the EU-MDR, there is a lot of common ground.
In summary, this is a significant regulatory change in the Medical Device world. It will impact Data Management and Production equipment, and will have serious implications for companies who are not ready.
Industrial Production Processes (IPP) Ltd Director of Life Sciences Donal Harrington
What is a medical device?" U.S. Food & Drug Administration. 2016. Online. Accessed on 7 August 2019: http://www.fda.gov/AboutFDA/Transparency/Basics/ucm211822.htm
Read the new European Commission fact sheet on the Unique Device Identification (UDI) System.