The new EU Medical Device Regulations may slow down obtaining CE-marking

……and should solve major quality and safety issues.

Every time there is a public health scandal of some substance, the authorities respond with an overhaul of the relevant regulations. This was the case after the PIP (Poly Implant Prothèse) breast implant scandal.

In the meantime, other publications have implied that the “notified bodies” and the system under which they operate are ready for a serious upgrade.

The indication is that notified bodies have been claiming a 100% success rate, obtaining CE marking, even on insufficient files.

The Dutch television consumer program “Radar” went through the process of obtaining CE-marking for a vaginal mesh implant, based on the design of 4 products already marketed in Europe. The file (brochures!) detailed a product that was very similar to “Prolift”, a mesh that was taken off the market due to its notably inferior features and unsuitable material. In actual fact, the “product” was made from a supermarket net used to hold tangerines. In spite of the “booby traps” built into the file (mentioned in the brochure) and no attempt to hide the serious potential product shortcomings, the notified bodies were willing to guarantee CE Certification in the shortest possible time.

CE marking is a key indicator of a product’s compliance with EU legislation and enables the free movement of products within the European market.

Any medical device placed on the European market must comply with the relevant legislation, notably with: Directive 93/42/EEC, the active implantable devices Directive 90/385/EEC or with the in vitro devices Directive 98/79/EC. The first step is to determine whether the devices you intend to manufacture or import fall under any of these Directives.

All medical devices must fulfill the essential requirements set out in the above-mentioned Directives. Where available, relevant standards may be used to demonstrate compliance with the essential requirements defined in the EU Directives.

Manufacturers also need to determine the appropriate conformity assessment route. For devices falling under Directive 93/42/EEC other than custom-made devices and devices intended for clinical investigation, the conformity assessment route depends on the class of the device, to be determined in accordance with certain rules.

The CE Mark demonstrates that the relevant product conforms with the essential requirements set within the European Union. This means that the product is safe and fit for the purpose for which it was made. Moreover, the CE Mark shows that the manufacturer has complied with the legal conformity requirements and that the product may be freely sold within the European Union and the European Free Trade Association (except for Switzerland).

According to the classification rules given in Annex IX to the directive, devices are classified as follows:

Class 1 for low-risk devices

This includes hospital beds, incontinence diapers, ordinary Band-Aids, external splints, spectacle glasses, examination gloves, reusable surgical tools, non-invasive electrodes etc.

Class IIa for medium-risk devices

This includes catheters, ultrasound equipment, blood filtration equipment, standard contact lenses, surgical gloves, dental fillings, hearing aids etc.

Class IIb for medium-risk devices

This includes hemodialysis equipment, standard intra-ocular lenses, drug administration devices, anesthetic apparatus, contact lens fluids, blood bags, X-ray equipment etc.

Class III for high-risk devices

This includes cardiac valves, neurological catheters, implants with a biologically active coating etc.

First and foremost, the devices must be designed and manufactured in such a way that, when used under the conditions and for the purposes intended, risk will be minimal. Any risks which may be associated with their use should constitute acceptable risks when weighed against the benefits to the patients and are compatible with a high level of protection of health and safety. Detailed requirements are specified.

The Notified body is a certification organization designated by the national authority of any EC country (Competent Authority = CA), which is authorized to conduct conformity assessments in accordance with the procedures in the directive. The notified body offers its services to the manufacturer with the aim to have the manufacturer’s product put on the European market in alignment with the directives. The notified body performs its activities in a competent, neutral, independent and non-discriminatory manner.

The tasks of the notified body in the conformity assessment procedures to be observed are described in the annexes to the directive. This section will outline the major tasks for each procedure (text “The European association for Medical devices of Notified bodies”).

The television consumer program “Radar” pointed out a couple of issues that should be considered “serious risks” in the system. The fact that Notified bodies are commercial organizations that have in a large number of cases insufficient expertise to be able to perform the necessary tests, including clinical tests, and that the manufacturer has substantial influence in the involvement of (clinical) experts is to be considered hazardous. Manufacturers are tempted to start shopping for the Notified bodies that offer “fast tracking”  and a 100% guarantee that CE marking would be obtained.

The new regulations that are expected to take effect towards the fourth quarter of this year have undergone substantial alterations since the release of an initial proposal that was presented in September of 2012.

The major changes will be:

  • Newly created Notified bodies will be able to issue CE Certificates for high-risk devices (Class III).
  • Common Technical Specifications (CTS) will be expanded to all devices.
  • Competent Authorities will audit Notified bodies for compliance,  jointly.
  • Most implants will be classified as Class III , requiring technical documentation (design dossier).
  • In vitro Diagnostics will now also require Notified Body involvement.
  • The European Databank on Medical Devices, “Eudamed” will be expanded and the UDI, Unique Device Identification will be required for labeling.
  • There will be a revision of the declaration of conformity and the technical files.
A slow down in process and increased costs should be anticipated as a result of the changes in the European medical device regulations. The addition to “article 44”, a process of scrutiny allowing authorities to have a second look at the Notified bodies review of the technical documentation, prior to CE Marking approval may be a concern. Other changes will also have an effect on delay, cost and result.

It does not really make sense to come down on a process that has been full of flaws and allowed certain manufacturers to cut corners with the help of sometimes inferior Notified bodies, governed by regulations that were obviously insufficient.

In the end, the new regulations will prove to be beneficial, first of all to patients but definitely to quality manufacturers that are able and willing to take responsibility.
For manufacturers it makes sense to select a Notified body on the basis of quality and not on the basis of the (claimed) speed of result irrespective of the content of technical files.

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About Helgert Van Raamt

Helgert van Raamt has 35 years of experience in running and setting up companies, big and small, in EMEA (and beyond). After his senior marketing positions with Organon Teknika and Abbott Labs and four years in Venture Capital as an investment manager for US, UK and NL based funds, he joined Nellcor Europe in 1989 and has lead this company through two consecutive M&A’s (Puritan Bennett and Mallinckrodt). The acquisition by Mallinckrodt for 2.7 Billion made Nellcor the most successful Medic venture after the Second World War. He left to set up the International Operation of Aspect Medical Systems and brought that to success. In three years it reached a revenue level of $10 million and was profitable two months after the start of the operation. Since then (2003) he has successfully advised numerous companies about setting up internationally or cleaning up an existing international operation, both independently and as a partner for TforG Group.