Introduction

At the end of September 2012, the European Commission (EC) published two proposals which will fundamentally change placement of medical devices on the EU market. This follows the scandal caused by the French manufacturer (Poly Implant Prothèse) which apparently used industrial silicon instead of medical grade silicone for the manufacture of breast implants, causing potential harm to thousands of women around the world.

Around 500,000 or more different types of medical devices are available on the market. These include a huge spectrum of products, from home-use items like sticking plasters, contact lenses and pregnancy tests to dental filling materials, x-ray machines, pacemakers, breast implants, hip replacements and HIV blood tests. Existing EU legislation has not kept pace with the enormous technological and scientific progress. Additionally, it has been interpreted and implemented differently throughout the EU. Moreover, it has failed to provide access to essential information on medical devices for patients, healthcare professionals and others.

Therefore the EC has published proposals for two new regulations that will ensure a high level of human health and safety, smooth functioning of the internal market and meet the growing expectations of European citizens while preserving an innovation-friendly approach.

Once adopted, one regulation will set rules for in vitro medical devices (IVDs), while the other will cover remaining medical devices, including active implantable medical devices (AIMDs).

Common aspects of the proposed regulations

The new rules envisage stricter and more detailed monitoring and enforcement requirements both for entities responsible for conformity assessments (notified bodies) and for national competent authorities within the EU.

The proposals do not set a pre-marketing authorisation system, but rather a "scrutiny procedure" whereby a Medical Device Coordination Group (MDCG), composed of EU Member State experts and chaired by the EC, will review and have the opportunity to comment on draft summaries of conformity assessments of high-risk devices. Notified bodies will be required to give "due consideration" to comments received from the MDCG, and justify not following  those comments.

Other significant features of the two proposed regulations include:

  • more unannounced inspections by notified bodies and member state authorities, and increased requirements for accreditation and supervision of notified bodies;
  • quality management system responsibilities proportionate to the risk class of each specific device, and a requirement to appoint a "qualified person" responsible for regulatory compliance, comparable to similar EU requirements regarding medicinal products;
  • increased clinical evidence requirements, stricter requirements for trials for regulatory purposes, introduction of the "sponsor" concept, and enabling a single clinical trial submission for trials carried out in several member states;
  • detailed responsibilities for importers and distributors, including clarification of requirements applicable following relabeling and repackaging;
  • increased transparency measures, including a single registration database, a requirement to ensure traceability throughout the supply chain, and introduction of a Unique Device Identification system; and
  • introduction of an EU portal where manufactures will have to report serious incidents and corrective action, and which will make such information automatically available to the relevant member state authorities.

Under the proposed regime, all notified bodies will need to be re-designated three years (medical devices and AIMDs) and five years (IVDs) after the proposals are adopted and in force. Notified bodies will be assessed according to stricter requirements, which may lead to more specialised, and fewer, notified bodies.

Some specific aspects of the proposed IVD Regulation

The proposal clarifies and extends the scope of legislation compared to the current regime with respect to high-risk devices manufactured and used within a single health institution, genetic tests and companion diagnostics and medical software.

The proposal also introduces a new risk-based classification system for IVDs, under which IVDs are placed in four classes, and conformity assessment procedures have been adapted in line with the new classification system. Class A (low risk) devices will generally be assessed under the sole responsibility of the manufacturer, with the exception of, eg, devices intended for near-patient testing. Class B and C devices require assessment of the quality management system by a notified body, while high-risk class D devices also require explicit approval of the design or type of device before being placed on the market.

Some specific aspects of the proposed Medical Device Regulation

The proposed Medical Device Regulation will cover both medical devices that are not IVDs, and AIMDs, which were previously governed by a separate Directive. Compared to the current regime, the scope of the regulation has been extended to:

  • products manufactured with substantially manipulated non-viable human tissues and cells, not covered by the EU Regulation on advanced therapy medicinal products;
  • certain implantable and invasive products without a medical purpose that are similar to medical devices in terms of characteristics and risk profile;
  • articles that fall under the extended definition of an "accessory".

The proposed Medical Device Regulation introduces the "common technical specification" instrument, which was already used with respect to IVDs, as well as a requirement that patients implanted with a device should be given essential information regarding the device, allowing it to be identified and containing any necessary warnings and precautions.

Conformity assessment procedures, which continue to apply depending on classification in one of the four classes of device, have been tightened and streamlined. Under the proposed regulation, AIMDs are classified in the highest risk category (Class III).

What are the next steps?

The Commission proposals will be discussed in the European Parliament and the Council. They are expected to be adopted in 2014 and will gradually come into effect from 2015 to 2019. Considering that the revised legal framework will likely remain in place for years, stakeholders should be actively involved in the legislative process until adoption of a legal framework to ensure that their interests are adequately represented in order to avoid overly burdensome requirements. We recommend that stakeholders thoroughly review the proposed regulations ( proposed Medical Device Regulation and proposed IVD Regulation), assess their implications and consider the next steps.

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.