Dental News - Medical device regulations are on track

Dental Tribune International

Sat. 11. November 2017

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BRUSSELS, Belgium: In April, the European Parliament voted to implement a pair of new regulations concerning medical devices. First proposed in 2012 by the European Commission, the regulations are intended to improve safety in medicine and dentistry within the European Union. Since then, the regulations have officially entered into force, and dental distributors across Europe have been busy preparing for the ensuing changes.

Having entered into force on 25 May, the regulations will be applied after a transitional period of three years from this date for medical devices and five years for in vitro diagnostic medical devices. For dental distributors, this means that these rules will apply from 26 May 2020, when the transitional period expires. Designed to remedy inconsistencies in adherence to the existing directives, these regulations will be applicable in each of the EU member states and should provide a clearer framework regarding device standards to patients, professionals, and relevant domestic and international regulatory bodies.

According to Sarah Jaques, a competition and business lawyer with the Belgium-based contrast law firm, distributors will need to ensure that certain requirements under the medical device regulations are met before the device can be made available for purchase. “A distributor will be required to verify that the devices have been CE-marked and an EU declaration of conformity has been drawn up; that the manufacturer has fulfilled its obligation to accompany the device with certain information; that, if an importer is involved, he has made its information available on the device or its packaging; and that, where applicable, a unique device identifier has been assigned by the manufacturer,” said Jaques.

“The regulations require that dental distributors have appropriate procedures in place to conduct this verification exercise.”

Jaques emphasised that distributors will be required to forward complaints or reports they receive from medical and dental professionals and patients on to the manufacturer of the device concerned. “In addition, the distributor must keep a register of complaints, non-conforming devices, and recalls and withdrawals and make that information available to the manufacturer at its request,” Jaques added.

Another new feature of the medical device regulations is that member states are required to enforce them and adopt penalties for any infringements of its requirements. It therefore becomes all the more important for dental dealers to familiarise themselves with their new obligations and to ensure compliance.

In anticipation of the new regulations, dental distributors are encouraged to commence certain preparatory measures. These measures should include the following:

reviewing whether their agreements with manufacturers meet the requirements of the new regulations
seeking confirmation from manufacturers and importers that necessary measures are being undertaken to ensure that the devices distributed after 26 May 2020 are compliant with and bear the CE marking in accordance with the new regulations
making an internal assessment of whether additional procedures must be set up to ensure compliance with the new regulations.