On Sept 26, 2012, the European Commission (EC) proposed two Regulations which would replace the existing rules regarding sales of medical devices and in vitro diagnostic medical devices in the EU.
The EC estimates that around 500,000 different current products would be covered, with a sales value (2009) of some EUR95 billion. In addition to the 27 EU countries, five other countries would be covered by the rules (including Norway, Switzerland and Turkey).
The proposals will now be discussed in the European Parliament and in the European Council. The EC’s target is that they will be adopted in 2014 and come into effect over a period starting from 2015.
Who will be affected?
Any business selling or proposing to sell medical devices or in vitro diagnostic medical devices in the EU or these other countries should be aware of the proposed changes. The rules will not only apply to products manufactured in the EU, but also to imported products.
What will change?
Among the most significant proposed alterations to the current regime are the following:
- Wider scope: The rules will be extended to include, amongst other new products, implants for aesthetic purposes, non-corrective contact lenses, certain products manufactured using non-viable human tissues or cells, genetic tests, companion diagnostics and medical software.
- Rules on Making Products Available: There will be clearer rights and responsibilities for manufacturers, importers and distributors when developing and bringing products to the market. Manufacturers will need to have a qualified person dealing with regulatory compliance. Amongst other changes, there will be new requirements for patient information concerning implantable devices and new rules on the reprocessing of single-use devices.
- Rules on Traceability: Traceability is going to be improved, including through requirements for devices to be fitted with a Unique Device Identifier, for suppliers and devices to be registered on a database and for high-risk device manufacturers to make publicly available a summary of safety and performance.
- Rules for Notified Bodies: “Notified Bodies”, the regulatory bodies which in each country carry out audits of manufacturers’ systems and documents and also approve some devices, will be given enhanced investigatory powers. These include powers to carry out surprise factory inspections (“dawn raids”) and to conduct tests on devices.
- Rules on Conformity Assessment: The basic self-assessment (“conformity assessment”) regime for approval of devices, with the involvement of a Notified Body varying dependent on the type of product involved, remains in place. However, the procedures under which Notified Bodies check manufacturers’ internal procedures will be tightened and streamlined. In addition, in what is probably the most controversial part of the proposals, a new “expert committee” (the Medical Device Coordination Group (MDCG)) will be established to oversee applications made to Notified Bodies for approval of high-risk devices. This “second look” approval is seen by some commentators as a move towards a centralized pre-market authorization system as found in the U.S. and as an unnecessary additional layer of bureaucracy.
- Rules on Clinical Evaluation and Investigations: There will be new, stricter rules for clinical investigations on devices and concerning the clinical data which must be collected during the life cycle of a device.
What should I think about?
As noted, all devices sold in the EU will be subject to these rules, so any medical device or in vitro diagnostic medical device manufacturer, supplier or distributor active in the EU needs to be aware of these proposals and should start to think about how they would impact its business. Will some of your products now come within the rules? Are you happy that your procedures will be compliant, e.g. on testing? Do you have a concern about, for example, the MDCG? The proposals are still up for discussion, so affected businesses can consider whether they want to try to influence their shape.
For more information, see the EC’s medical devices website.