New MDCG guidelines for MDR compliance of older devices and requirements for parallel imports into the EU

New MDCG guidelines for MDR compliance of older devices and requirements for parallel imports into the EU

Introduction

There is a need for improved MDR compliance of older devices in the EU. There is also a need to review the requirements related to parallel imports. Therefore, the Medical Device Coordination Group (MDCG) published two guidelines on October 20, 2021. The MDCG is the expert panel of the EU member states and the EC. These guidelines are a useful manual for, on the one hand, the manufacturers, importers and distributors of so-called "legacy devices" and, on the other hand, the parallel importers. For the first group, the guidelines deal with which MDR obligations they must comply with (Guideline 2021-25). Regarding the parallel importers, the guideline mainly focuses on the repackaging and labeling of medical devices under Article 16 MDR/IVDR (Guideline 2021-26).


New MDCG guidelines for MDR compliance
New MDCG guidelines for MDR compliance of older devices and requirements for parallel imports into the EU

Guidance for MDR Conformity of Legacy Devices

Medical devices certified under the previous directives 93/42/EEC or 90/385/EEC may remain on the market for a transitional period without being certified under the MDR. This is described in Article 120(3) of Regulation 2017/745 on medical devices. The date of application of the MDR is May 26, 2021. However, there is a condition that the MDR requirements regarding surveillance and vigilance are met. Now it is the case that many medical devices are still using this transitional mechanism. So the following question arises: What monitoring and surveillance obligations specifically must be met by importers and distributors of such older devices? This question is of critical importance.

MDCG advice on existing devices and devices placed on the market before May 26, 2021

Directive 2021-25 provides guidance on the application of the MDR requirements to 'existing devices' and to devices placed on the market before May 26, 2021, pursuant to Directive 90/385/EEC or Directive 93/42/EEC. The document provides detailed guidance and, in particular, addresses the extent to which periodic safety reports (PSUR) must be prepared. Surprisingly mildly, the MDCG opinion is that manufacturers of older devices do not need to designate a PRRC for those older devices. A "Person Responsible for Regulatory Compliance" is responsible for regulatory compliance. This runs counter to the previously held, stricter view that a PRRC is necessary for older devices as well, for oversight and vigilance purposes. In view of these new guidelines, manufacturers, importers and distributors of older medical devices will need to carefully assess their current processes and adjust them as necessary.

Parallel import of medical devices

Directive 2021-26 provides additional questions and answers on the repackaging and re-labeling of devices. The title of this directive is 'Questions and answers on repackaging & re-labeling activities under Article 16 of Regulation (EU) 2017/745 and Regulation (EU) 2017/746'

The parallel importer must notify the original manufacturer under Article 16(3) MDR/IVDR. It is notable that the MDCG considers that this does not apply to older medical devices. However, the guidelines do not address the question of whether parallel importers of older devices must notify the trademark holder of the original manufacturer. This is based on ECJ jurisprudence on trademarks for pharmaceuticals. Original manufacturers are therefore advised to:

  • establish and maintain robust procedures;
  • monitor and take enforcement action against non-compliant or trademark-infringing parallel trade in their medical devices.

It states that importers and distributors must have a quality management system (QMS) that ensures the accuracy of the relevant procedures. Procedures regarding the handling of non-compliant devices, market recalls and, if necessary, corrective action procedures must be defined in the QMS. In addition, importers and distributors obtain a certificate issued by a notified body certifying that the QMS meets the requirements set out in the same provision.


New MDCG guidelines for MDR compliance of older devices and requirements for parallel imports into the EU

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