28 June 2018 - Authored by:
The Medical Devices Regulation (MDR) entered into force on 25 May 2017 providing for a three year transitional period until its full application as of 26 May 2020. While there is still time left before 2020, preparation is crucial especially for economic operators. The MDR will bring important changes to the current EU regulatory landscape and manufacturers, authorised representatives, importers and distributors need to be well-informed about how their role is going to change.
While manufacturers will be able to market their products under a MDD or AIMDD certificate for some years after 2020, several actions need to be taken before the time the MDR applies. Besides, the MDR provides the possibility for early prepared manufacturers to place devices on the market under the new requirements before 26 May 2020.
Authorised representatives are also highly affected by the application of the MDR since the new requirements will substantially change their role. So are importers and distributors, which are not covered by the MDD and AIMDD but are conducting their operations following non-binding EU guidance such as the Blue Guide of the European Commission or in accordance with national requirements imposed by each Member State. To the contrary, the MDR attributes clear roles and sets obligations for all the aforementioned economic operators.
Person responsible for regulatory compliance
The MDR introduces a new obligation for manufacturers to have a person responsible for regulatory compliance available within their organisation. Micro or small enterprises may have such a person not within their organisation but permanently and continuously at their disposal. According to Commission Recommendation 2003/361/EC, a small enterprise is defined as an enterprise which employs fewer than 50 persons and whose annual turnover and/or annual balance sheet total does not exceed EUR 10 million. A micro enterprise is defined as an enterprise which employs fewer than 10 persons and whose annual turnover and/or annual balance sheet total does not exceed EUR 2 million. However, the definition of SMEs is currently under review by the European Commission following a recent public consultation.
The terms “permanently and continuously available at their disposal” are not further explained. It can be assumed, however, that this person may be an external consultant. Authorised representatives are also required to have a person responsible for regulatory compliance that, similarly to micro and small enterprises, must be permanently and continuously at their disposal.
The person responsible for regulatory compliance must comply with the academic and/or professional criteria imposed by the MDR. The person responsible will have to ensure that the conformity of the devices is checked, the technical documentation and EU declaration of conformity are drawn up and that post-market surveillance and reporting obligations are fulfilled.
The MDR requires manufacturers to have measures in place to provide sufficient financial coverage in respect of their potential liability for defective devices under the Product Liability Directive (PLD). This obligation is without prejudice to more protective measures under national law.
In addition, under the MDR, authorised representatives will be legally liable for defective devices if the manufacturers established outside the EU have not complied with their MDR obligations. This new liability of authorised representatives was introduced by the Council during the legislative procedure with the purpose of facing enforcement issues with manufacturers located outside the EU. However, the consequences of this change may significantly affect manufacturers since authorised representatives will be turned into monitoring operators with the possibility to unilaterally terminate their agreement in case the manufacturer does not comply with the MDR.
Importers and distributors
Importers and distributors are specifically regulated under the MDR, while the MDD and AIMDD do not provide any rules regarding their role or obligations. The European Commission’s Blue Guide currently provides guidance for importers and distributors but it is not legally binding and its application largely depends on the decision of these economic operators to follow it or not. The MDR incorporates the majority of these rules. Importers and distributors already complying with the Blue Guide will therefore not face great changes to their management system but they need to know that, once the MDR will apply as of 26 May 2020, these obligations will be enforceable and failure to comply with them may trigger sanctions.
The MDR also imposes some brand new obligations. Among these, importers must register to the electronic system for economic operators and forward to the manufacturer complaints or reports from healthcare professionals, patients or users about suspected incidents related to a device placed on the market by them.
Distributors must check compliance of manufactures and importers (if applicable) with the MDR by applying a sampling method representative of the devices that they have supplied. Additionally, distributors will be obliged to keep a register of complaints of non-conforming devices and of recalls and withdrawals.
After the PIP scandal, identification and traceability of medical devices became one of the most important concerns underpinning the revision of the current system. The Unique Device Identification (UDI) system will allow the identification and facilitate the traceability of devices. The MDR provides obligations related to the UDI system for every economic operator. Therefore, manufacturers will have the responsibility to assign the UDI on the label of the device or on its packaging before placing it on the market. In addition, manufacturers must provide to the UDI database the relevant data elements related to the device. Authorised representatives, importers and distributors have the obligation to verify if the manufacturer complies with the UDI registration requirements.
Economic operators should start adapting their systems and procedures and provide the necessary budget in order to comply with the upcoming MDR requirements.
This post was co-authored by Eftychia Sideri & Marco de Morpurgo.