EU Regulatory News
- The European Commission has appointed a replacement for Mr Norbert Anselmann, who headed
the unit responsible for medical devices legislation in European Commission DG III until
July 1998. The new head of unit, Dr Antonio Lacerda, will transfer from the health policy
unit in DG V but will not be in place until November 1998. Mr Bo Höjdefors has
transferred from the Swedish National Board of Health and Welfare to replace Robert
Virefléau, who goes to the French Notified Body G-Med.
- One of the most important decisions for the future of the US biomaterials supply
industries was made end-July 1998 by the US Congress, which passed the Biomaterials Access
Assurance Act (HR 872). The Act was signed into law by President Clinton during August
1998. It protects suppliers of biomaterials or components of implanted devices from
liability if an entire device results in injury, provided it was not a fault of the
material or component. This Act is a response to serious concern in the industry following
lawsuits costing millions of USD against raw materials suppliers whose contribution to the
disputed devices were not at fault and were worth only hundreds of USD.
- In July 1997, as a result of concerns about BSE and human disease, the European
Commission proposed and adopted Decision 97/534/CE with an effective date of 1.1.98. This
Decision sought an immediate EU-wide ban on the import into the EU and use of
‘Specified Risk Materials’ (SRM) of animal origin in human and animal food and
feed chains. The actual effect would have been to ban such materials from a wide range of
products including medical devices, biomaterials, medicines for humans and animals,
cosmetics and industrial products such as motor oils and gelatine-based films for cameras
and X-rays. No account was taken of the origin of such materials or the dependency of so
many industrial and pharmaceutical sectors. After this, the reaction from industry and
regulators alike was so intense that the European Commission was forced to rethink its
approach. Attempts to replace the original Decision by more realistic ones have collapsed.
The end result is that the Decision remains but the effective date has been pushed further
and further back and now stands at 1 January 1999. Undoubtedly, this date will be further
revised, since the Commission is now considering a horizontal Directive to replace the
Decision, and this is expected not to be ready for at least another 12 months. The policy
of inaction is the only one that appears to be allowing continued use of materials of
animal origin, even from TSE-free countries, allied with the TSE Guidelines produced by
the CPMP (Committee on Proprietary Medicinal Products) in 1991.
- The Transition Period for the Medical Devices Directive ended June 14th 1998. From that
time forward, new devices can be put on the market in the European Union only if they
comply with the Directive and carry a CE mark hat has been obtained according to the
procedures described in the Directive. Devices that do not carry the CE mark can still be
supplied and used provided that they were ‘properly put’ on the market before
June 14 the 1998 and were in the EU distribution chain at that time.
Products that were previously regulated as medicinal products but have been
re-classified as devices will be treated as devices after June 14th, and
require CE marking. This includes most wound dressings and bone cements.
- One of the topics to be discussed by EC DG XXIV’s Advisory Committee on Medicinal
Products and Medical Devices is whether certain products are better regulated under
medicines legislation or devices legislation. This is particularly important for
‘drug-device interface’ products. These are the subject of Guidelines MEDDEV
2.1/3 revision 5, published in February 1998 by the EC. The major point of principle is
that a product is regulated under one system or the other, but different elements may
require consideration by the relevant authority. For example, a plain bone cement is a
medical device. A product dossier would be submitted for assessment to the relevant
devices authority. A bone cement to which an antibiotic is added to control infection and
thereby aid long-term fixation is still classified as a medical device. Although the
regulatory authority to which application is made would be that dealing with devices, the
assessment of the antibiotic part of the product would be carried out by staff from the
medicines regulatory authority. On the other hand, a bone cement, the primary purpose of
which is to carry and release antibiotics in an osteomyelitic bone cavity or an infected
fracture site, would be a medicinal product and regulated by the medicines authority, with
advice from the devices authority or a Notified Body on any devices aspects.
Other biomaterials-based devices that will be regulated as medicinal products include
wound-healing products comprising a matrix, wound dressings containing antimicrobials used
for controlling infection, products releasing bone growth factors to aid bone healing and
temporary root canal fillings that deliver antimicrobial agents. The Guidelines indicate
that materials for the transport, nutrition and storage of organs for transplantation
should be regarded as medicinal products. Dental filling materials, tissue sealants and
adhesives, wound-healing products and bone defect fillers are regarded as devices, even if
they contain pharmaceutically or biologically active agents, provided that the prime
purpose is not as carriers and delivery systems for the active agents. Products in this
class include catheters coated with heparin or antibiotics, soft tissue defect fillers
containing local anaesthetic and bone void matrices where any added substance assisted or
complemented the matrix action rather than being the prime purpose in itself.
The Directive does not require an integral drug-device product to carry a CE mark, and
it is not clear how one could apply a CE mark anyway to something that is not really a
device. This question will need to be addressed. Case studies may be the best way to
formulate a pragmatic approach to this.
Before embarking on a development programme for a complex biomaterial or one that
contains pharmaceutically or biologically active components, it is vital to discuss and
decide whether the product will be regulated mainly as a medicine or mainly as a device.
Otherwise, the clinical studies programme and other tests of safety, integrity and fitness
for purpose may be designed for the ‘wrong’ regulatory agency.
- Continued negotiations have been taking place between the European Commission and the
French authorities in order to reduce the over-stringent requirements put in place in
France for the regulation of medical devices, especially with regard to pre-market
approval procedures. These are the result of French concerns that the Medical Devices
Directive did not provide adequate safeguards, especially since many devices are in as
close a contact with the human body as a pharmaceutical product might be. The French
authorities have very strongly insisted that devices should not be assessed under ordinary
consumer-protection legislative systems. The Commission and the representatives of 6 other
EU Member States have been putting pressure on France to modify and moderate its approach.
In return, it appears that the French views have been taken into account in the In Vitro
Diagnostics Directive, which is much more detailed and stringent than early
industry-agreed drafts.
- Progress towards the MRA (Mutual Recognition Agreement) between the USA and the EU has
been derailed due to the changes in regulatory status of certain devices such as
orthopaedic implants that the FDA has recently enacted. The European Commission is ready
to agree to the MRA but the FDA wants the reclassified products removed from the scope of
the MRA. However, during the renegotiations, which everyone hopes will be short, European
Notified Bodies will continue to work on their acceptance by FDA as Conformity Assessment
Bodies (CABs). Up to now, FDA has not been completely happy with the consistency of NB
performance across Europe and this still has to be ironed out for FDA acceptance. Over 10
European NBs have announced they will apply for accreditation as CABs to the parties
involved in MRAs with the EU, including Australia, New Zealand, Canada and USA.
- The FDA is moving ahead with a rule requiring products containing natural rubber latex
to be labelled, in order to minimise allergic reactions and deaths following
hypersensitivity. The international concerns about natural rubber latex are leading some
companies to turn to high-purification latex or to synthetic alternatives for coatings,
sealants and materials used in surgery and in devices.
- The Global Harmonisation Task Force is considering whether a European Union central unit
for adverse reactions reporting should be set up, to assist EU Member States in managing
reports and recommending actions on an EU-wide basis. The current thinking is that the
European medical devices database EUDAMED will be expanded to deal with this.
- European device and drug-device developers and manufacturers are waiting to see whether
the UK Department of Health will merge the Medical Devices Agency and the Medicines
Control Agency, as a result of a study recently commissioned by the Department to
investigate the advantages and disadvantages of doing this.
   
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