PLIP stands for Product Liability Insurance Policy, an insurance coverage that best satisfies one of the mandatory requirements of Medical Device Regulation (MDR) linked to potential liability of manufacturers.
What the MDR says about liability
Product liability protects users in the event of product damage. In this sense, Article 10 (16) of the MDR obliges the manufacturer to have sufficient financial coverage for potential liability of defective medical devices. Additionally, Article. 11 (5) makes the authorised representative jointly liable together with the manufacturer for defective devices. For this reason, it is essential that a manufacturer obtains an insurance contract that sufficiently covers their company, but also their authorised representative in case of potential liability claims in Europe.
PLIP for Indian manufacturers of legacy medical devices
With a large number of manufacturers and innovative technologies, the Indian medical devices industry plays an important role in the supply of medical products in Europe. Legacy devices (reusable surgical instruments, Class IIa devices, etc.) are subject to a special status to facilitate the transition from the previous Directives to the Medical Devices Regulation and most importantly to avoid a sudden shortage of medical devices on the market. Despite the special status, manufacturers of legacy devices are subject to the same PLIP requirements as MDR medical devices.
- PLIP is the best tool to protect manufacturers and authorised representatives against potential liability claims under MDR.
- Manufacturers can provide a PLIP obtained from an insurance company in their home country. To obtain a PLIP, Indian manufacturers should contact an insurance firm that offers coverage from risks posed by defective devices (product liability).
- PLIP should have sufficient insurance coverage proportionate to the risk class of the device.
- The name of the authorised representative should be clearly stated ad included under PLIP as additionally insured.
- The PLIP should be kept valid, and any changes communicated to the authorised representative.
Obelis has 35 years of experience in EU regulatory affairs for medical devices. Over the decades, our team of professionals helped thousands of manufacturers to achieve compliance and smoothly enter the EU market. If you appoint Obelis as your Authorised Representative, we will be your regulatory partner and support your business in Europe, taking care of all obstacles you might face. Don’t let regulatory challenges hold your business back!
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