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European regulations 2017/745 and 2017/746

Newsletter - November 2017

The practical steps of rolling out European regulations on medical devices 2017/745 (MD) and 2017/746 (IVD MD) have started and the various actors concerned must actively prepare themselves to meet the obligations of the future regulatory framework...

European regulations on medical devices 2017/745 (MD) and 2017/746 (IVD MD): the practical roll-out steps have started

Various working groups are currently meeting under the auspices of the European Commission to implement the various systems required by the regulation, particularly the content of the European database :
Image règlement européen dm et dmdiv

  • registration of economic operators,
  • registration of products,
  • Unique Device Identifier (UDI),
  • vigilance data,
  • data accessible to the public,
  • designation of notified bodies,
  • CE marking certificates,
  • post-market surveillance data,
  • clinical investigations and performance studies.

Working groups about the interpretation of the directives are still active.

The Commission implementing regulation (EU) 2017/2185 of 23 November 2017 on the list of codes and corresponding types of devices for the purpose of specifying the scope of the designation as notified bodies in the field of medical devices under Regulation (EU) 2017/745 of the European Parliament and of the Council and in vitro diagnostic medical devices under Regulation (EU) 2017/746 of the European Parliament and of the Council has now been published.

Finally, a process for adopting a correction of a purely editorial nature has been started, the aim of which is to correct the errors contained in the two regulations.

Obligations and actions of the various organisations involved

For the economic operators (manufacturers, authorized representatives, importers, distributors), it is vital to understand and be prepared to comply with the provisions of the future regulatory framework. They also have to organise the transition in keeping with their strategic objectives for putting existing products and new products under development on the market.

In a similar vein, organisms that have taken the decision to submit an application as notified body or reference laboratory must actively prepare designation applications and take the necessary measures for organisation and resources..

The member states and various departments of the European Commission are also hard at work to build the regulatory tools needed for the regulations to operate 'routinely'.
New involved organisations, such as issuing entities of Unique Device Identifiers, are also mobilised.

Two Forums were organised in December 2017 devoted to the European MD and IVD MD regulations

In order to help MD and IVD- MD manufacturers to meet the regulatory challenges caused by the reform, both major Forums organised by LNE every year for organisations involved in the medical sector have put the focus on key points of regulatory news within the European Union without losing sight of the concomitant amendment of associated standards and other regulatory frameworks.

Regarding the European MD and IVD MD regulations, the description and operational procedures for consulting national authorities have been presented, as well as the associated implementation agenda. Deployment of the UDI system, a summary of requirements for clinical assessment and post-market obligations, have all been tackled. More specifically on the in vitro diagnostics sector, what will happen for products already marketed but not yet assessed by a notified body has been explored.

Three presentations were dedicated to software, software as tools of the quality management system, in vitro diagnostic software and cybersecurity. Requirements relating to nanomaterials have been reviewed and commented.

A company has shared its experience of the MDSAP programme.

This event brought almost 200 participants together.

LNE/G-MED remains more mobilised than ever, both in France and at a European level, to offer its experience and clarification on the implementation of assessment procedures, and in this perspective to take part in drafting long-term answers to the many questions that are being asked.

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