While the Medical Devices Regulations are making their way through the European legislative process, it may be good times for medical device manufacturers that sell their devices within Europe take a closer look at the proposed regulations. This past June 19, 2015, the EU Council published their proposed revisions to the proposed regulations governing medical devices and IVDs in Europe.
While there is no final document to work with as of yet, a manufacturer can still learn from the proposed changes so far. Some of the important changes included in the proposals are changes to the classification provisions, including the definitions of some terms and changes to classes for some devices. If a device is up-classified, the manufacturer may have a lot of homework before their device can stay on the EU market. As a result, it’s important that manufacturers understand these definitions and what may change in the coming Regulation.
Ordinary Legislative Procedure
The medical devices regulations are currently in the middle of the “ordinary legislative procedure.” Most of the laws and regulations that are adopted in the EU go through this procedure. It is also known as the co-decision procedure, because Parliament and the Council decide together on the content of the regulations and laws that are approved.
Step 1 – The EU Commission Proposes Legislation
The first step starts at the EU Commission. The Commission, after hearing input from various sources like citizens’ initiatives, the EU Central Bank, EU investment bank, and member states, studies the different routes they can propose and decides on a legislative proposal. This proposal is sent around the block to the EU Parliament.
Step 2 – The EU Parliament’s First Reading
The second step is the Parliament’s first reading of the EU Commission’s proposed legislation. At this first reading, the Parliament debates as to what amendments it should make to the Commission’s proposals, and includes those amendments into its own submission. The different Committees in Parliament write the amendments to the legislations. While one Committee may have primary responsibility for a piece of legislation, other Committees can weigh in on legislation and give their proposed amendments for consideration by Parliament. Once Parliament agrees on their amendments, the entire submission is then sent back across the street to the Council of the European Union. There is no time limit on the Parliament’s first reading.
Step 3 – The Council’s First Reading
The third step is the Council’s first reading of the proposed legislation, along with the Parliament’s amendments. The Council can accept the Parliament’s amendments and automatically adopt the legislation. However, the majority of proposals are further amended. Currently, the medical devices regulations are at this stage; the Council started their review of the proposals at the end of 2013. Early news reports state that the Councilmembers are keen on making some changes, although there isn’t much of a consensus covering what changes they would make. It would be wise for medical device manufacturers to watch the evolution of the proposals from the Council. There is no time limit on the Council’s first reading.
Step 4 – The Parliament’s Second Reading and Trilogue (Where the Proposals are Now)
After the Council decides on its changes to the submission from the Parliament, the submission goes back to the Parliament for further debate and amendment. In most cases, Parliament adopts the changes the Council made, and the proposal turns into law. Parliament may also make further amendments to the proposal, which would then return back to the Council for a second reading there as well. If the Council does not approve the amendments, the proposal heads to conciliation and further readings and debate in Parliament and the Council for a final determination of whether or not to adopt a piece of legislation.
Once Parliament and the Council agree on the text of the legislation and vote to adopt it, it is up to the EU Commission to enact and enforce it.
Scope and Definitions
Before classifying a medical device, it is important to determine if there is a medical device in the first place. The regulation’s scope and definitions sections outline what the regulation covers and what it doesn’t. As the proposed regulations have moved through the legislative process, the EU Parliament and Council have left their own marks on this section, including and excluding different categories of products. One inclusion that the EU Council has included in their edits is for the medical devices with human products as ancillary substances, which the EU Commission did not explicitly include in their original proposal. One exclusion is that the EU Council has excluded standalone software from the definition of an active device.
In addition to the definitions governing the types of products that the regulation covers, there are also changes to the definitions necessary for classification. As in the MDD, there is a section in Annex VII, the annex pertaining to classification, which describes the different terms used to classify a medical device. The EU Council’s revisions include a new definition for “injured skin or mucus membrane,” and include this in its definition for a “Surgically invasive device.”
There are some classification changes that manufacturers should take into account. These classification changes invariably change the class of the device from a lower class to a higher class, and so manufacturers of these devices should carefully monitor the regulatory requirements as they change to absorb the impact. For example, the EU Council’s proposed regulation places partial and total articular implants in class III (currently in class IIb), and the spinal disc replacement and implants in contact with the spinal column are also up-classified into class III. In addition, accessories for active implantable devices are also placed into class III. Devices that had their own directives in the previous regulatory scheme, including breast implants and load-bearing orthopedic implants, are also explicitly placed in class III.
Interestingly, the EU Council’s proposed regulation also places one type of non-invasive device into class III. According to Rule 3 in Annex VII of the EU Council’s proposed revisions, a non-invasive device, “…consisting of a substance or a mixture of substances intended to be used in vitro in direct contact with human cells, tissues or organs taken off from the human body or with human embryos before their implantation or administration into the body are in class III.” This is also an example of how the proposed regulation changes the regulatory landscape with respect to today’s technology.
While the EU Medical Device Regulation’s aren’t in force just yet, it’s important that manufacturers examine the proposed revisions and amendments from the EU Parliament and Council. One reason is to track the changes in the classifications for the different devices to better absorb any changes in conformity assessments when the Regulation is enforced. As a leading European Notified Body, LNE/G-MED has considerable regulatory and technical expertise in guiding manufacturers through the necessary regulatory interpretations.