May 3, 2016

As we wrote earlier, European Regulations for Medical Devices and IVDs are still in their “First Reading” stage. In order to come to the formal First Reading document, the European Parliament, the Council and the European Commission are now negotiating under the Dutch EU-presidency.


The Dutch appear to be doing a very good job keeping the negotiations productive and informing stakeholders about the progress. We were invited to a second meeting that was organized for stakeholders on 28 April 2016 to provide information about the current state of affairs.

 The main message brought to the industry was that it is highly likely that the First Reading version will be agreed upon in mid-June.

There appear to be two items that are still under fierce debate: genetic counseling and reprocessing of single-use devices. Neither of these issues was discussed in any detail, although it appears a compromise between Parliament and Council about reprocessing met strong resistance by the Commission.

Other open items are still moving towards workable compromises:

  1. IVD classification, rules 1 (serious infectious diseases), 4 (self-tests, near patient tests) and 5 (accessories, instruments, specimen receptacles)
  2. The concept of near-patient testing (IVD)
  3. Prescription rules as mentioned in Article 1 (6) (IVD)
  4. Chapter VI, clinical data (IVD)
  5. Chapter VII, periodic safety report (IVD)
  6. Certificates issued during the transitional period (MD as well as IVD)
  7. Exceptions for well-established technologies such as orthopedic screws and plates (MD)

State of play

From the above it is clear the negotiations are effective. You can also see that some pragmatism is being applied when it comes to the conformity of devices with obviously proven safety. Some of the fears that well-established therapies will no longer be available because of devices that are no longer CE-marked will not come true. However, this will not be applicable to all devices, and it will not do away with some of the other challenges, like the accreditation of notified bodies.

The First Reading version of the Regulations will be made public as this is also a Parliament document. Of course Emergo will make this available as soon it is published, hopefully during the second half of June.

Preparation for the transition

The big questions the medical device industry is struggling with are how to prepare for the transition and when to start. Based on last September’s Council version of the proposals and the above, the broad picture is more or less clear:

  • A higher level of clinical evidence will be reviewed by a relatively small group of intensely reviewed notified bodies that also have to certify many more IVDs.
  • All economic operators will have to take part in ensuring compliance and can be held responsible for non-compliance.
  • Citizens will have access to more data about the devices and regular updates regarding safety and PMS have to be made public. To allow for effective control more information must be uploaded to Eudamed and it must also be kept up to date.

Although this information is very general it can help individual organizations to get the transition process started. Companies should consider the following preliminary steps in preparation:

  1. Verify device status - Analyze the definitions of “Medical Device” and “In-vitro Diagnostic Device.” Pay special attention to accessories and products that you currently supply that are not within the scope of the Directives; they may now fall within the scope of the Regulations.
  2.  Verify the risk class - Apart from the Rules mentioned above it is likely all other rules are now in their final version. Much of the guidance that can now be found in MEDDEV 2.4/1 is proposed in Annex VII (both Regulations). It is therefore possible to have a strong indication of what the risk class your device(s) will be under the new legislation.
  3. Perform a gap assessment - Once you have established the risk class, you can make a first attempt at a gap assessment regarding the conformity assessment. Article 40 and further for IVDs and article 42 and further for medical devices will provide you with the procedures and requirements.

Start now

Start by downloading the Council’s September 2015 version of the proposals for medical device regulations and annexes as well as IVD regulations and annexes. It appears many items of this version will make it to the final version. By the time the First Reading version is published you may have a first version of your gap assessment. You may want to verify your initial device classification. By that time the details of the conformity assessment procedures will become clear. Of course Emergo will follow these developments closely and provide updates as we learn of them and can confirm their validity.

Ronald Boumans is Senior Global Regulatory Consultant at Emergo’s office in The Netherlands, and a former senior inspector at the Dutch Healthcare Inspectorate.


  • Ronald Boumans