The European Commission’s proposal to revise the medical device legal framework is a welcome step towards strengthening and improving the EU regulatory system. Recognised globally as being the fastest in providing life-saving technologies to patients without compromising safety, this thorough overhaul of the regulatory system seems to be mostly in line with Europe and President Barroso’s stated policy of ‘Smart Regulation’: ensuring the quality and relevance of EU legislation, which should benefit people and businesses.
When considering Eucomed’s position on the proposed measures we always take the following three questions into account:
- Does the proposed measure increase the safety for patients?
- Does the proposed measure allow life-saving medical technologies to be made available to people in Europe just as fast as today?
- Does the proposed measure encourage innovation that European healthcare systems urgently need to become more efficient?
If we are able to answer one or more of the three questions with a ‘yes’, it is likely that the proposed measure will be supported by industry.
This article will discuss 13 proposed measures, listing the ones we fully support, followed by those we believe should be modified and ending with some comments. I can already tell you that we see most of the measures as positive. Our main concern lies with the proposed scrutiny procedure which can be found in Article 44. The scrutiny measure answers ‘no’ to all three questions mentioned above. It will fundamentally change the current system and will not lead to the desired outcome of increased safety for patients.
The Measures Industry Supports
1. Improvements in notified bodies
Recognised as the major area for tightening up, the proposed regulation now sees tough and stringent requirements on both the quality and competence of notified bodies and the job they carry out in checking manufacturers and their products. How notified bodies are approved and monitored by authorities is also improved with clear specific criteria for authorities in choosing competent bodies. A new layer of checking of all bodies across Europe by teams of authorities with the European Commission has been added. Notified bodies are given the clear mandate to ensure thorough testing and regular checks, including unannounced factory inspections at manufacturing sites.
These proposals are welcome and appropriate. In particular, Eucomed fully supports unannounced factory inspections.
The current vigilance system lacks sufficient coordination to be fully effective at European and national level. The proposed text provides the necessary legal basis and databases to do this. Eucomed welcomes the creation of a European Database managed by the commission which will include the centralization of notifications and the coordination of the commission.
3. Transparency and Unique Device Identification
A new single registration database is in the pipeline and is long overdue. The fact that nobody can tell anybody what’s on the EU market without consulting 27 member states needs to be urgently addressed. An extended database on medical devices is proposed, providing comprehensive and public information on products available on the EU market. Patients, healthcare professionals and the public will have access to the certain data concerning medical devices available in Europe, allowing them to be better informed.
Better traceability of devices throughout the supply chain is established, enabling a swift and effective response to safety concerns. A Unique Device Identification (UDI) system will be introduced to enhance post-market safety of medical devices, to help to reduce medical errors and to fight against counterfeiting.
Eucomed welcomes these initiatives and stresses the importance of Europe’s UDI system being compatible with the global system already in development.
4. Clinical evidence
Despite recent criticism that clinical evidence for medical technology does not exist, it does. And it has always been a legal requirement under EU law. Perhaps in an effort to address this, and to improve clarity, the proposed regulation re-writes, improves and clarifies the requirements for the generation of clinical evidence and clinical investigations. A new system for centralization of notifications is introduced as well as a severe adverse event reporting system to ensure patient and consumer safety. Particular emphasis is laid upon protection of subjects undergoing clinical investigations and measures related to establishing requirements for extended post marketing clinical follow-up.
Eucomed welcomes the improvements especially on clarification on the requirements and rigor for clinical investigations and the central notification system. There is a clear intention to reduce times and bureaucratic burden and to add certainty to the justification when new or additional clinical investigations are not necessary.
All players in the European regulatory system have known for a long time that the current system is good but suffers from fragmented and un-harmonised implementation. It’s a management issue as it were. Eucomed is glad to see that the two main players in this, the European Commission and member states, will have more and stronger powers in coordination and management. A new Medical Device Coordination Group (MDCG), made up of members appointed by the member states due to their role and experience in the field of medical devices and chaired by the commission, is set up.
The new structure ensures that an internal market focus is brought to bear while still retaining the huge benefits of the decentralised approach with member states in charge of implementation. The commission will take on the coordinating role to help member states manage the system. This role includes for example: providing the necessary technical, scientific and logistic support; development of necessary European databanks and infrastructures for data exchange and organization and participation in joint assessments of notified bodies. The commission will be charged with the elaboration of several implementing and delegated acts which are needed for a proper functioning of the Regulation. The commission will also be the coordinator of several activities where member states will be asked to act jointly. In addition, EU reference laboratories, a new concept from the food sector, may in the future be designated by the commission in relation to specific hazards or technologies. The success of this new concept will be proved over time.
Eucomed welcomes the enhanced role of the commission services and the stronger legal basis for member state cooperation to improve the coordination and management of the system.
The commission is proposing that the scope of the law should be extended to include, for example, implants for aesthetic purposes, devices containing or being made of non-viable human tissues, and clarified, for instance, as regards medical software. Devices containing any viable substance (human, animal or other) are now clearly excluded.
We support the expansion of the scope as it increases patient and consumer safety. We will be assessing with our members any practical concerns in terms of implementation with regards to the positive listing within the legislation and other exclusions such as devices containing bacteria.
7. Standards & Guidelines
The commission reiterates the fundamental role of European (and international) standards in providing a high level of protection to patients and consumers. A small but significant proposed change is the expansion of the possibility to have Common Technical Specifications (CTSs) not only for IVD devices but also for medical devices in general, for cases where no standard exists. Broadly seen as useful in the IVD world, the success of these CTS in the general medical area will only be evident over time.
Long a bone of contention for industry, better management of the development and harmonised implementation of EU guidance will become one the formal responsibilities of the new MDCG.
Industry would agree to the above only if the development process of guidelines is supported by a policy of full stakeholder involvement via a formal advisory committee made up of representatives from valid stakeholders (industry, patients and physician groups).
8. Reprocessing of Single Use Medical Devices
The commission follows the recommendations of its independent Scientific Committee on Emerging and Newly Identified Health Risks, SCENIHR, and proposes to assign to reprocessors the same duties assigned to manufacturers. Some products will be allowed to be reprocessed only after appropriate evaluation from the commission and member states. Member states will be left free to prohibit reprocessing on their territories.
Eucomed supports the commission’s proposal and would add the importance of ensuring that the notified body has audited the quality management system of the reprocessor and has found the reprocessor’s process suitable for that category of products.
9. Economic Operators
The players in the game will all be assigned clear roles and responsibilities: manufacturers, authorized representatives, importers and distributors. Diagnostic services and internet sales are also included. Early indications are that the details may cause problems when looked at across all organizational models and supply chain structures that exist within the industry.
The proposed text will be analysed by Eucomed’s members to determine whether the requirements match and if not suggest changes to keep them relevant and implementable.
Fees (Article 86) are nothing new; the proposal now expresses explicitly what was previously implicit. Each member state, in line with its own exchequer and budgetary policy and its own ideology on government structures, determines how it funds and resources its responsibilities under EU law. In medical devices, this national approach means that today industry pays government differently in each member state in a variety of ways e.g. payment to government via notified body fees, via fee-for-services, via national registration databases, via other fees levied by government etc.
Eucomed is in regular dialogue on fees. This dialogue includes the foreseen changes, such as a central registration database and new tasks in the revision and will no doubt continue. It may be that a national approach remains; the objective should be to have an appropriate and sustainable funding model that demonstrates benefits to both the regulator and the regulated.
The Measure Not Supported by Industry
11. Mechanism for ‘scrutiny’ of certain conformity assessments
Powers will be given to the MDCG to oversee, in exceptional cases, the work of notified bodies for new Class III devices in case of novel technologies, specific public health threats or uneven evaluation by a notified body. The proposed scrutiny procedure would retain the European decentralized approach but would change the system by adding an unnecessary time delay at the end of the review process.
We view the delay as an additional unnecessary bureaucratic addition to the already improved and strengthened CE marking approval process. On top of that, it is at the end of the review cycle and it would always be better to have early scientific advice than late scrutiny. The unnecessary duplication and time delay will not increase safety and will result in patients waiting longer for life-saving medical technologies in Europe. The delay could be anywhere between 6 months up to 1,..2,..3,..(?) years.
12. Stakeodler involvement
There is no explicit reference to a stakeholder advisory committee. Such a committee exists today through the medical devices experts group (MDEG) which is open to representatives from valid stakeholders (industry, patients and physician groups). The proposed Medical Device Coordination Group may establish standing or temporary sub-groups. Organisations representing the interests of the medical device industry, healthcare professionals, laboratories, patients and consumers at Union level shall be invited in such sub-groups but only as appropriate and only in the capacity of observers.
Experience has shown that progress in the EU is only possible when the different players share a common vision and a common direction. The System benefits today from an active ‘Advisory Committee’ as part of MDEG. This principle should be kept and given explicit reference in the legislation. Otherwise decisions and policy lacks the early and rightful input of patients, doctors, industry and others.
The proposal merges the two previous Directives: “Active implantable medical devices” and general “Medical devices”. As a result all devices covered by the active implantable medical devices directive become de facto Class III. In addition, the following new rules have been added:
- Certain devices incorporating nanomaterials are Class III;
- Devices for aphaeresis are Class III;
- Devices that are composed of substances or combination of substances intended to be ingested, inhaled or administered rectally or vaginally and that are absorbed by or dispersed in the human body are in Class III.
The merging of the texts should, in theory, not give rise to any issues in relation to active implantable medical devices and their accessories. Eucomed will be analysing the proposed text in detail to determine whether it gives rise to any unintended classification anomalies. In particular, we will be looking at the impact on active non-implantable medical devices. These products are already properly classified under the current medical devices directive.
For the other new rules, Eucomed will seek to understand from the commission and health authorities the identified problem being tackled and the duly justified reason to introduce the specific classification rule. It needs to be certain that the new rules are duly and scientifically justified and will actually address the health issue.
Resource and Cost Implications for Industry
Regulatory changes bring adjustments which have cost and resource implications especially for SMEs. This regulatory revision is a major overhaul of the system and we expect the implications to industry to be significant. UDI alone is estimated to cost a typical large-size company €10-15 million.
In addition, no small cost should be attributed to the adaptation of manufacturers’ systems and procedures to be ready for the new rules and increased levels of inspections, not to mention the costs of re-registrations in other countries outside the EU who recognised European approvals and CE marking due to the foreseen changes in EU certificates. Here the costs also can be estimated in millions of euros.
The revision of the medical device directives contains some sweeping new concepts but broadly the direction is positive. The debate is now in the Council and the European Parliament. We will continue to support the majority of improvements and explain our strong concerns on scrutiny. I expect the commission’s proposal to be mostly viewed as positive by the Council and Parliament and hope they bring sensible and practical amendments with patient safety, patient access and the fostering of innovation and medical progress in Europe in mind.
The optimist in me would hope for adoption before the European elections in summer 2014. I trust that then I’ll be writing about a legal text that places Europe once again as the leading light in innovation; innovation not only in technology but innovation in how to regulate smartly, guaranteeing safety, quality, relevance and bringing a benefit to people, businesses and governments.
– John Brennan, Director Regulatory and Technical Affairs Eucomed
This blog post first appeared in Clinica on 10 October 2012.