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(Alliance News) - Inspiration Healthcare Group PLC on Monday said it has received a new EC Certificate for its products, extending their marketing under the European Union's existing medical device rules.
The new European Union Medical Device Regulation will come into force in May 2020 and involves reinforcing rules on clinical evidence and increased surveillance of products already on the market. These stricter controls are intended to address concerns that have arisen around harmful silicone breast implants, as well as metal-on-metal hip implants which can wear down quickly and damage bone.
Inspiration has six products which are use for stabilisation, assessment, and resuscitation in premature and sick infants. It also has products which are aimed at maintaining a normal blood pressure before, during, and after surgery.
Having received a new EC certificate, Inspiration will be able to market these products under the existing medical device directive until May 2024. Consequently, its products will avoid being "adversely affected" by the new rules.
Chief Executive Neil Campbell said: "We are pleased to have extended the EC Certificate which allows us to continue to promote the products whilst we review our technical documentation and apply for conformity to the new Medical Device Regulation. Our new and innovative products in our [research & development] pipeline are already being developed with MDR in mind and we expect a seamless transition to the MDR in due course."
Shares in Inspiration, which has its headquarters in West Sussex, were down 1.3% at 66.10 pence in London on Tuesday morning.
By Anna Farley; annafarley@alliancenews.com
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