The European Council's Permanent Representatives Committee and the European Parliament’s Environment and Health Committee on Wednesday endorsed the agreement reached on the continent’s new medical device and in vitro diagnostic (IVD) regulations, a day after the draft versions of the texts were released.

Following a legal-linguistic review of the two documents planned for September, the Council and Parliament could adopt the two draft regulations by the end of 2016, according to the European Council. The new rules will apply three years after publication for medical devices and five years after publication for IVDs.

The new regulations – which cover not only the design and manufacture of devices, but also clinical testing, authorization and post-market surveillance – will have an impact on just about every device manufacturer that sells products in the EU, and they come as tens of thousands of Europeans suffered over the last decade from metal-on-metal hip replacements and faulty breast implants.

Dame Glenis Willmott, a UK member of the European Parliament who led the work on the EU’s new regulations, said in a statement on Wednesday: “The metal-on-metal hip scandal highlighted weaknesses in the current system. So we’ve introduced much stricter requirements for the [notified] bodies that authorise medical devices, and will insist that particularly high risk devices, such as implants, joint replacements or insulin pumps, will be subject to additional assessments by experts before they can be authorised.”

Background

The release of the draft texts and signing off on them by the two committees follows the announcement late last month that an agreement had been reached after years of negotiation.

The compromise, according to the European Parliamentary Research Service, centers on stricter requirements for notified bodies, stronger pre-market scrutiny and post-marketing surveillance; strengthened rules for high-risk devices and certain other categories of devices; and increased transparency and traceability.

Jérôme Unterhuber, spokesman for the Council of the European Union, told Focus two of the sticking points holding up the negotiations dealt with the reprocessing of devices meant for single use and genetic tests.

"The [Netherlands] Presidency of the Council and the representatives of the EP [European Parliament] agreed that reprocessing and further use of such devices will only be possible where it is explicitly authorised by national law and will be subject to strict rules ensuring safety. For reprocessed single-use devices all the responsibilities of the original manufacturer go over to the reprocessor. The EP had originally asked to allow reprocessing of single-use medical devices unless it is banned by member states," Unterhuber told us.

And as far as genetic tests, he said, "The EP had asked that where a genetic test is used for instance to diagnose the predisposition of diseases member states must provide the tested person with relevant information on the significance and the implications of the genetic test. Since the organization of the health system is a national competence the Council (which, as you may know, represents the 28 member states) was not able to accept this demand. At the end, the 2 co-legislators agreed that member states provide this kind of information 'as appropriate.'"

Draft Texts

One of the focal points of the new regulations is the idea that all devices and IVDs have to be safe and effective.

“This Regulation aims to ensure the smooth functioning of the internal market as regards medical devices, taking as a base a high level of protection of health for patients and users and taking into account the small and medium sized- enterprises that are active in this sector,” the draft text says. “At the same time, this Regulation sets high standards of quality and safety for medical devices to meet common safety concerns as regards these products.”

To that end, all medical device manufacturers offering products in the EU will be required to establish risk management systems and quality management systems, though manufacturers of Class I self-certified devices are exempt from requirements whereby their quality management systems are assessed by a notified body. 

Manufacturers may rely on equivalent products for bringing new devices to market only in limited circumstances, and for implantable devices and those that are Class III, or highest risk, clinical trials must be performed unless it’s a modification by the same manufacturer of an already-approved device.

Also included in the texts are new requirements for importers, distributors and accessories to sterilized products. Authorized representatives will also be held liable for defective medical devices, meaning they will have to more closely scrutinize non-EU-based manufacturers more carefully.

“Importers shall keep a register of complaints, of non-conforming products and of product recalls and withdrawals, and provide the manufacturer, authorised representative and distributors with any information requested by them, in order to allow them to investigate complaints,” the draft text says.

And according to the device experts at the Emergo Group consulting company, CE mark certificates issued prior to final implementation of the new regulations in late 2019 or early 2020 will have a maximum validity of five years. However, all CE mark certifications issued before implementation of the new regulations will automatically expire four years after the new regulations come into force.

Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on medical devices, and amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009

Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on in vitro diagnostic medical devices