After four years of negotiations, European lawmakers have agreed on a new EU Medical Devices Regulation (MDR). The MDR is the alike the US FDA’s CDRH regulations and fundamentally postulates the appropriate rules when introducing medical devices into Europe - the world’s second largest medical device market. The rules take into account the product classification, pre-market authorization, quality system standards, and reporting of adversarial measures.
The final version of the MDR was recently published and is currently being reviewed by the EU’s legal editor for drafting or law-technical inaccuracies. This will then be deciphered into all EU member languages, followed by formal publication. After publication, as expected by early 2017, there will be a three-year transition period as the medical device industry will need time to conform to the new requirements.
Some key changes have been made pertaining to the medical devices market in the EU. There are newresponsibilities on businesses. Unique Device Identifiers (UDI), similar to the system for the US market, will be familiarized step by step to escalate traceability of devices through the supply chain, as well as to facilitate product recalls if need be. This may bring about the maker having to modify the product label. Makers will also be obligatory to involve a medical device expert accountable for regulatory compliance management. Makers will also be obligated to take out an insurance policy for likely liability claims for faulty devices.
Other operatives in the supply chain apart from the makers also face new compulsions. MDR emphasizes on companies bound to check out on quality, performance and safety of devices even after they are introduced into the market. Even the alleged private notified bodies will exercise the right and duty to execute impromptu on-site audits and to perform physical or laboratory tests on medical devices to confirm unremitting compliance.
Pre-market sanction, nevertheless, stays serious as well, and is likely to be on the forefront than in the current system. The manufacturers will be required to constantly review and update their current quality systems and technical files owing to the growth of the indispensable conformity requirements, now entitled General Safety and Performance Requirements. They will also need to be proactive in data collection to aid safety and efficiency. This is undoubtedly the situation for clinical assessment of devices, especially uber-risk ones such as implantable devices.
Other supervisory requirements are likely to come to order in terms of numerous business practices such as reprocessing of single-use devices, relabeling, repackaging, and hospital produced or home brew devices.
The new MDR assures enlarged product opportunity. Few products that are presently not qualified as medical devices are expected to come under the definition of a medical device. This would bring them within the range of the MDR such as products used for disinfecting or sterilizing other medical devices or devices for purposes of control or support of conception. Their accessories like devices used to place or remove invasive or implantable contraceptives will also be covered by the MDR.
Devices without intended medical purposes, but relatively of cosmetic or aesthetic nature for example contact lenses, liposuction or laser equipment for skin treatment is considered a medical device. While lifestyle or wellbeing software is not measured as a medical device, all software and mobile health apps intended for any of the purposes involved in the definition of medical devices will be regulated. In vitro diagnostics are not bound by the MDR but fall under the freshly approved stand-alone regulation.
The European Database for Medical Devices (Eudamed), the equivalent of the US’s MAUDE database, holds facts on medical devices acquired from the European Commission and national authorities. Under present rules, only these authorities can access Eudamed. Nevertheless, Eudamed access will be expanded now to market participants like patients, notified bodies, manufacturers, healthcare professionals and the public. The available medical device data will include post-market surveillance data, UDI and SRN data, conformity assessment applications, and safety and clinical performance sum-ups.
Read more on: