Changes to European Medical Device Regulations - how does it affect Ireland?
24 Aug 2016
Nigel O'Leary
With so many medical devices companies based in Ireland, the new European regulations governing medical devices and in-vitro diagnostics will have an impact - not least on costing, traceability and skills resources.
Although it’s going to take a number of years to come fully into effect, the new changes to the Medical Device Regulations and the In Vitro Diagnostic regulations will begin their trial periods shortly. This is expected to run approximately from 2017 to 2020. This will give firms operating in the EU or planning to introduce devices into the EU a chance to fully assimilate the changes into their organisation and procedures.
For my clients based in Munster and Connacht, awareness and implementation of these changes will be vital for their continued success.
For some firms, this may introduce the need to bring in new skills and knowledge to accommodate the changes and ensure their implementation to stay ahead of the game. Does your company have the required skillsets in Quality Engineering and Compliance? If not, they’re likely to become some of the most in-demand skills in our marketplace in 2017 so now is the time to look at your skills resources.
So, what are the main changes that companies need to be aware of?
Firstly, the types of devices and products that will actually be considered a “medical device” in the first instance will expand considerably. Where we would normally think of items such as stents and orthopaedic joints the new regulations will now include many pieces of equipment or devices used in cosmetic surgery and tattooing. Also now covered by the legislation will be contact lenses and cosmetic fillers.
This will potentially pull lots of manufacturers into a process where they will need to significantly alter and upgrade their systems to accommodate the more onerous regulations. This will certainly introduce headaches in increased cost and potentially slow down or frustrate approvals and access to the market.
Another significant change which is likely to cause some pain in the industry is the increased scrutiny on higher risk devices and invasive devices such as implants. The key to conforming to this will be the large scale introduction of individual serialisation and traceability which will be demanded by the notifying bodies.
The entire text of the new changes are available now at the ec.europe.eu website for interested parties and I would recommend checking them out as soon as possible. The trial periods will pass quickly and there will be no hiding from them once they are implemented in full.
To discuss any requirements in the Life Sciences industry across Munster or Connacht, feel free to give me, Nigel O'Leary, a call at Brightwater’s Cork office on 021 4221000 or at [email protected]