The revision of the European legislation on medical devices is aimed at making medical devices safer and rebuilding the trust of patients. Rather than implementing the system change that was being planned after the silicone breast implant scandal in 2010, the EU called for open public consultation to prevent such incidents from occurring. As a result, revision of the legislation has been ongoing since autumn 2012.
Representatives of the European Commission, Council and Parliament are struggling to find a compromise for a new version of the European regulatory framework on medical devices (Medical Device Regulation, MDR). For the proposals to become law, the text needs to be adopted by the Council at first reading and the Parliament at the second reading. When the author of this article talked with Dr. Peter Liese, one of two European Parliament rapporteurs, on March 31st 2016, the latter envisaged that the two new proposals on medical devices and in vitro diagnostic medical devices would be ready by mid-May.
The current regulatory framework on medical devices comprises three directives that came into force in the 1990s. In the new regulations, two of the three existing directives, the Council Directive 90/385/EEC on Active Implantable Medical Devices and the Council Directive 93/42/EEC on Medical Devices, will be merged as one single regulation (Medical Device Regulation, MDR). In vitro diagnostic medical devices (IVD), currently governed by Council Directive 98/79/EC, will also in future have their own specific legislation. Once adopted, the proposals for legislation will be enforced in all EU member states and will not require national implementation as is the case for the three existing EC directives. The transition period for medical diagnostic devices and active implantable medical devices regulations is three years and for IVDs, three to five years.
Unlike drugs, marketing authorisation for medical devices is not granted by a central authority, but is subject to conformity assessments conducted by private sector testing laboratories (so-called notified bodies). This applies to medical devices with medium to high risk potential (class II and III) on human health. Once the notified body has determined that a manufacturer has conformed to the valid assessment criteria, it issues a CE certificate to show that the devices assessed meet the requirements. Manufacturers of class I medical devices wishing to obtain CE marking are responsible for ensuring that their product complies with all relevant requirements and drawing up a self-declaration to this effect. Medical devices manufacturers are free to choose any of the notified bodies in Europe.
The revision of the European medical devices legislation has quite a story behind it: in 2008, a European Commission (EC) public hearing identified numerous deficiencies; in 2010, after the breast implant fraud scandal after French manufacturer PIP was found to be using cheap silicone, further deficiencies came to light. In autumn 2012, the EC presented two proposals to the European Parliament and the Council of Ministers, one on medical devices (MDR) and the other on in vitro diagnostics devices. The Parliament responded with 342 amendments to the MDR; the Council of Ministers agreed on a common position on 19th June 2015. Since 13th October 2015, the European Council and the Parliament have been seeking compromises in trialogue meetings, informal tripartite meetings attended by representatives of the country that holds the rotating EU presidency and two rapporteurs from the Council and the Commission. The meetings are not public.
Under the MDR, notified bodies such as TÜV and DEKRA will be monitored more closely and work to the same standards. This practice was introduced by the EC back in September 2013 (Implementation Directive No. 920/2013/EU). While mutual control of the EU member states is currently still voluntary, it will become mandatory under the MDR.
The so-called regulatory procedure with scrutiny (RPS), an examination of high-risk products by additional experts, something to which the German government was originally opposed, will also become a legal requirement. It will apply to implantable class IIb and III devices, but only in justified cases, for example products with non-assessed health risks. Liese reports that costs will have to be covered by the manufacturers; SMEs will be given a rebate. The EC will choose the examiners in corporation with its Joint Research Centre where they, together with member states, will constitute panels of examiners. Germany vehemently opposed this suggestion based on the conviction that a complex network of clinical expert panels would be necessary to deal with a large number of assessments out of hours, in addition to their regular jobs. The German Ministry of Health also claimed that the RPS was hostile to innovation, and hence to start-ups and SMEs.
A so-called implant passport, which was introduced in Germany on 1st October 2015, will also become mandatory across the EU. All patients with active implants, heart valves, non-absorbable vascular prostheses and stents, knee and hip joint replacement implants, vertebral body replacement systems, intervertebral disc prostheses and breast implants will be required to carry one (source: BVMed).
The new legislation requires medical devices to be traceable. Each device will be given a UPI (unique product identifier) that identifies the manufacturer from whom the devices are purchased. Since March 2014, Notified Bodies need to demonstrate that they conduct unannounced factory inspections at the manufacturer's premises. The revised EU medical device legislation now makes this mandatory. “This was our main concern,” says MEP Peter Liese.
The new texts will contain a precise description of the application procedure for class IIb and III products. “Details are still being discussed, but the principle will remain the same,” says Liese. René Betz, an approval specialist, believes that the MDR will bring more clarity to the preparation of technical documentation. Betz manages the Department of Regulatory Affairs at Metecon, a company from Mannheim that focuses on the approval of medical devices and related areas. Metecon’s customer base is mainly small and medium-sized medical device manufacturers. Betz further reports that the recommendation made by the European notified bodies (NB-Med 2.5.1.) was included in the initial proposal. It both concretises and interprets the approval requirements, which Betz considers is very helpful for manufacturers that mainly supply the German-speaking market.
Adoption of the MDR will also have consequences for Eudamed, the European Database on medical devices and in-vitro diagnostic devices. The revised database will provide more data and wider accessibility. According to Liese, practical implementation under direction of the EU Commission presents a huge challenge, which is why the MEPs are calling for an at least 1-year transition period for manufacturers to comply once the MDR has become effective.
Some contentious issues have not yet been discussed in the trialogue meetings. One is the Council of Ministers’ plan to subject specific product groups to a stricter regime than would be appropriate for their class, e.g. requiring the application of class III instead of class IIb regulations. Another unresolved issue concerns the provision to safeguard existing standards. A manufacturer liability insurance compromise has been found. It is hoped that this insurance will reinforce patient rights in the case of faulty products.
The problem relating to reusable surgical single-use instruments such as scalpels and scissors is still outstanding. The EU Council of Ministers plans to transform class I products into class II products, an idea that the Council of Ministers emphatically rejects. “We are working to find a compromise,” says Liese, admitting that he cannot foresee this happening. Liese explains the problem: The Council of Ministers argues that single-use instruments cannot be adequately sterilised in hospitals, which is why manufacturers need to amend the instructions for use with information on how single-use instruments can be adequately sterilised. To keep the issue in check, the Council contends that class II regulations need to be applied to class I devices. Liese finds this requirement rather odd.