Europe's Proposed Medical Device Regulation
On September 26, 2012, the European Commission issued a proposal to overhaul regulations for medical devices and active implantables. The proposal document is 194 pages long and is a more stringent approach to device regulation. It aims to bring about a transparent and traceable supply chain focusing on the life cycle of a broader range of products.
If implemented, being a regulation rather than a directive, it will be applied “as is”, bringing consistency across EU states.
The terms of the regulation itself are subject to change following discussion and approval by the European Parliament.
Once the final wording of the regulation is published it will enter into force 20 days later and come into full effect three years after that. Therefore, it is likely to be at least 2017 before manufacturers are required to comply.
Weaknesses of the MDD
The new proposal aims to correct weaknesses in the current Medical Device Directive (MDD). The biggest change concerns the oversight of notified bodies—which has led to inconsistency of implementation of existing rules from one member state to another as evidenced by recent reports by UK newspaper The Telegraph. It is also directed towards addressing the problem related to post-market surveillance, highlighted recently by the PIP silicone implants scandal, whereby competent authorities do not have sufficient mechanisms to monitor information and implement market surveillance.
Definitions
There are more definitions in the proposal document than the MDD—50 compared with 14. The definition of a medical device has been expanded to include aesthetic implantable devices (for example cosmetic breast implants or non-corrective contact lenses) and invasive devices used in humans with associated examples.
Medical Device Coordination Group
The proposed regulation would involve the establishment of an expert committee called the Medical Device Coordination Group, made up of members from EU states and chaired by the EC. The group will be responsible for administration of the regulation and the scrutiny procedure related to high risk class III implantable devices (see later).
Economic Operators
With a view to achieving better transparency and traceability, Chapter II sets out requirements for economic operators—manufacturers, authorised representatives, distributors and importers. The responsibilities of all economic operators are defined.
Manufacturers and authorised representatives must have an approved qualified person appointed who is an expert in the field with qualifications. There are also requirements placed on the manufacturer with respect to quantity-structure-property relationships (QSPRs), technical documentation, quality management systems, post-market surveillance plans and clinical follow ups and labelling languages.
As far as distributors and importers are concerned, imported devices must bear the importer’s name on the device or its packaging. There are requirements that importers must carry out sampling of marketed products while monitoring complaints. Furthermore, these entities must declare that they have complied with the requirements of the relevant clauses in the proposed regulation document.
Additional Device Types
New devices to be included and specifically defined are: devices incorporating medicinal product and devices composed of substances or a combination of substances intended to be ingested, inhaled or administered rectally or vaginally; devices incorporating materials of biological origin; and software in devices and standalone software.
Eudamed Medical Device Database and Unique Device Identifiers (UDIs)
Chapter III proposes a process by which devices can be tracked within the EU. It consists of a newly established medical device database—known as Eudamed—with a mandatory requirement on notified bodies, economic operators and member states to input data. A key component of the system is the unique device identifier (UDI), a set of data which must be compiled and submitted for every device sold in the EU market. It is proposed that class III devices will be separated out and subject to a separate scrutiny procedure and, as part of the data submitted, a summary of safety and clinical performance must be included.
Notified Bodies
Perhaps the greatest proposed change to the regulatory system surr-ounds notified bodies and their metamorphosis from an industry partner into what Emergo describes as “a police-like extension of the authorities’ market surveillance apparatus”.
Existing notified bodies will be subject to annual monitoring by authorities and an assessment once every three years by a joint assessment team. There are also new minimum requirements for notified bodies, set out in annex VI.
The proposal also sets out terms for the so-called scrutiny procedure—how a notified body should notify the Medical Device Coordination Group about new implantable class III devices, including the presentation of a Summary of Safety and Clinical Performance document created by the manufacturer. When explaining this requirement, Emergo pointed out that many manufacturers may not have completed this document at this stage.
Overall, the proposed legislation over notified bodies is expected to be costly. Clinical Evaluation and Investigation
As was generally expected, the roles of clinical evaluation and investigation are more prominent in the proposed regulation than in the MDD. There are requirements quoting specific ISO standards and guidance documents and Eudamed database registration is itemised. The process for a post-market clinical follow-up is also explained.
Market Surveillance and Serious Incidents
Under the proposal, manufacturers are required to report a serious incident within 15 days. The EU database will be used to share these reports to relevant bodies.
Industry Response
In general, the proposal has been welcomed by the industry. However, there have been concerns that the proposed scrutiny procedure for high risk class III devices is too tough and could stifle technological development and delay device uptake—a key competitive edge of Europe’s medical device industry at present.
At the same time though, other commentators have suggested that the proposal should be taken with a degree of political context. The Eucamed database will require an increase in spend by the European parliament and medical devices may not be outside the current climate of austerity for many member states. Getting the funding for the proposal through parliament may not be as easy as many people think.
Credits: The above article was compiled using information from medical device regulation consultants Emergo Group and Meddiquest.
The film below explains the view of Neil Armstrong of Meddiquest. He advises device manufacturers to familiarise themselves with the proposal but not to panic as it needs to be approved by the European Parliament.