The new EU regulations for Medical Devices – how ready are you?
They’ve already been three years in the making, and may not become law until 2019 at the earliest. But the proposed new EU regulations on medical devices and in vitro diagnostic medical devices (IVDs) are set to have a big impact on the supply chain.
Their aim is quite simple: to ensure better consistency and safer products in this very sensitive field. As is the way with such regulations though, they’ve already been through round after round of negotiation and revision, with the last amendments made in June 2015. The next stage involves negotiations between the European Parliament, European Council and European Commission, after which the final text will be adopted hopefully in early 2016.
The important changes
Some of the changes outlined are quite radical; so here’s a brief summary of how they could affect you.
The new regulations define ‘importers’ and ‘distributors’ for the first time; they also lay down strict new rules on confirming compliance. Each device must be verified as being CE marked with a declaration of conformity, accompanied by Instructions for Use and a Unique Device Identification (UDI).
There are new rules on labelling and registration on the EU database, and importers will be required to keep records of declarations and certification for at least 5 years, or 15 years for implantable devices.
There are strict rules on complaints, non-conformances and recalls too, with a firm emphasis on traceability – each party must be able to identify others along the supply chain and keep relevant records for 5 to 15 years (according to the type of device). You’ll find more detail on the regulations themselves here (link to original article, or EU document?).
If you’re an importer or distributor of medical devices or IVDs, you’ll find the new regulations give you a much greater responsibility. Whatever position you occupy in the supply chain though, it’s important that you ‘get your house in order’ well before the regulations come in.
Contracts will need updating with relevant clauses outlining responsibilities, internal process and procedures should be upgraded and you’ll need suitably trained staff in place to take care of the regulatory requirements.
Here, of course, is where you see the true value of having the right ERP system in place. ERP’s seamless integration, total transparency and full traceability along the supply chain make it much easier to readily adapt to fluctuations in the market…or in this case, radically different regulations.
The new rules may be unlikely to come into force for three years or more, but now’s the time to plan and prepare. Whether you already have an ERP system in place or not, as a leading Oracle and Sage ERP specialist Percipient can help put you in the best possible position to cope with any changes – whenever they occur.
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