On September 26, 2012, the European Commission issued its proposed revisions to the European medical device regulatory scheme to the European Parliament and to the Council. These revisions, if adopted, will have major and long-lasting impact on the medical device economic operators (manufacturer, authorised representative, importer, and distributor) around the world that import their devices into Europe. They will also modify the missions and responsibilities of the European Commission, the Health authorities and the notified bodies.
The European Commission states that the revisions may be adopted in 2014 and implemented between 2015 and 2019.1
Major Themes and Objectives to the Revisions
The European Commission gives three overall objectives to the revisions, which can be seen throughout the revision.2 The first objective is to ensure that human health and safety is protected at a high level. To reach this objective, the Commission included, among other things, a chapter on the requirements of clinical studies, increased post-market surveillance and vigilance activities for economic actors and the competent authorities, and a chapter on the traceability requirement for all devices. The second objective that the Commission had is to ensure that the internal market continues to function smoothly. The Commission states that this objective is reached by “…[putting] in place a regulatory framework that is applied with consistency across the EU….”3 A consistent regulatory framework would include, for instance, the clauses that close the legal disparities in the provisions of each member-state and the handling of borderline products and classification issues. Also, Annex XV of the proposal for a regulation for medical devices lists products that are included in the expanded scope of the definition of “medical device,” providing further clarification. The third objective is to provide a regulatory framework that is not only consistent, but also supports innovation and competition in the European medical device industry. The Commission examined the many different suggestions to change the current system, and decided that a stronger version of the current third-party assessment system is the most efficient system, keeping innovation and competitiveness strong.
A Brief Outline of the Two Revisions
There are two proposals for two regulations. One regulation is applicable to in vitro diagnostic medical devices and the second one is applicable to all other medical devices. Note that a regulation is a legal European text that does not need to be transposed in all the Member States’ national legislation.
The whereas-clauses identify the purposes of the changes to the legislation. It is always very interesting to read them, at least once, because, they provide the rational of the changes and also some interpretation trails of the text itself. According to the proposed transitory provisions, in the hypothesis of an adoption by the European Parliament in 2014, both regulations could be strictly mandatory in 2017 for medical devices and 2019 for in vitro diagnostic devices.
The analysis of both texts shows some common provisions/requirements such as (but not limited to):
• Art. 2 – New definitions;
• Art. 5 – Inclusion of the distance sales;
• Art. 7 – Inclusion of Common Technical Specifications of medical devices (they already exist for IVDD);
• Arts. 9 to 12 – Obligations for authorised representative, importers, and distributors;
• Art. 13 – Obligation for the manufacturer to have available within their organisation at least one qualified person responsible for regulatory compliance holder of a specific degree and/or experience;
• Art. 14 – Framework for situation of “parallel trade” (which includes the “Own Brand Labellers”);
• Chapter IV – Strengthening of the supervision of the notified bodies in particular regarding their competence and independency to carry out their tasks; and
• Chapter VII - Strengthening of the provisions governing market surveillance and vigilance.
Globally, the operational authority of the European Commission increases.
The analysis of each text shows some specific provisions/requirements such as (but not limited to) as follows:
Proposal for a Regulation on medical devices
(to replace: Directive 90/385/EEC regarding active implantable medical devices and Directive 93/42/EEC regarding medical devices)
• Arts. 1 and 2 - Modification of the scope (including now some implantable or invasive products (see
annex XV) even if they are not used for a medical purpose, and certain products manufactured
utilising non-viable human tissues or cells);
• Arts 23 and 24 – Traceability obligation;
• Art. 26 – Addition of a Summary of safety and clinical performance for Class III devices;
• Art. 41 – Addition classification rules;
• Art. 42 - Strengthening of the provisions of unannounced factory inspections and sample checks;
• Art. 44 – For some Class III medical devices, intervention, prior to the issuing of the certificate and in addition to the assessment procedure by the Notified Body, of a Medical Device Coordination Group (MDCG – see art 78) in charge of the review of the summary of the preliminary conformity assessment. The MDCG may request for any additional information, samples or an on-site visit to the manufacturer's premises;
• Art. 49 to 60 – Reinforcement of the rules governing clinical evaluation throughout the life of medical devices.
Proposal for a Regulation on in vitro diagnostic medical devices
(to replace Directive 98/79/EC regarding in vitro diagnostic medical devices)
• Arts. 1 and 2 - Modification of the scope (including now some high-risk devices manufactured and
used within a single health institution, tests providing information about the predisposition to a
medical condition or a disease, dedicated medical software);
• Arts. 21 and 22 – Traceability obligation;
• Arts. 24 – Addition of a Summary of safety and clinical performance for Class C and D devices;
• Art. 39 – Addition of risk based classification rules;
• Art. 40 – Contribution of reference laboratories;
• Art. 40 - Strengthening of the provisions of unannounced factory inspections and sample checks;
• Art. 42 – For some Class D IVDD, intervention, prior to the issuing of the certificate and in addition to the assessment procedure by the Notified Body, of a Medical Device Coordination Group (MDCG – see art 76) in charge of the review of the summary of the preliminary conformity assessment. The MDCG may request for any additional information, samples or an on-site visit to the manufacturer's premises;
• Arts. 47 to 58 – Reinforcement of the requirements for clinical evidence for in vitro diagnostic medical devices, proportionate to the risk class.
The Next Steps: How the Revision Becomes A Regulation
The European Union’s system of government is quite different from that of the United States’. The Constitution of the United States created three branches of government: the legislative, executive, and judicial branches, checking and balancing each other according to their duties, powers, and limits. The EU, however, is not built like the US Federal Government, and so even though the institutions and their duties may look similar, they are structured differently.
The European Commission is the EU’s executive branch, responsible for carrying out and executing the Union’s regulations and laws. The Commission also plays a large role in promulgating regulations and laws for the EU with the European Parliament and the Council of the European Union. The Commission, representing the interests of the EU as a whole, proposes new laws and regulations to the Parliament, representing the citizens of the EU, and the Council, representing the governments of the Member States. Through the ordinary legislative procedure, the Parliament and the Council read
the proposed legislation, in parallel, twice before voting on it. If both institutions agree on the legislation, the legislation passes into law and becomes the responsibility of the Commission to execute. The European Union has an informative page on their legislative process on their website at:
LNE/G-MED, as an established Notified Body, can help medical device manufacturers interpret how the Revisions will impact them. EU Regulatory experts are available for on-site training sessions and to give guidance with LNE/G-MED’s Regulatory and Technical Assistance. For more information on
how LNE/G-MED can guide you in interpreting the Revision, contact us.
2 Commission Staff Working Document: Impact Assessment on the Revision of the Regulatory Framework for Medical Devices. Part I. SWD(2012) 273 final. Pg. 22-23.
3 Id. at 23.