Devices using materials from TSE susceptible animals

All devices should have been fully compliant with the requirements of the Directive by 20 April 2005. MHRA is proactively checking that the required additional certification has been issued by the relevant Notified Body. Devices which do not have the additional certification should not be placed on the UK market after that date.

Guidance on the application of the Directive has been produced by the European Commission (MEDDEV 2.11/1).

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Summary of MHRA Policy for Compliance with Commission Directive 2003/32/EC

Background

1. Following the introduction of Commission Directive 2003/32/EC transposed into UK law by the Medical Devices Regulations 2002 No 618 amended by SI 2003 No 1697, relating to devices utilising material from TSE-susceptible animal species. Manufacturers of affected devices already on the market had until 30 September 2004 to obtain complementary certification. From 01 April 2004, new products coming onto the market need to be assessed in accordance with the new procedures in directive 2003/32/EC before being placed onto the EU market. Further guidance on this process can be found on the Commission website.

2. Delays experienced by some Member States in both confirming the designation of Notified Bodies and in transposing the Directive into National legislation (neither experienced by the UK) resulted in the Commission agreeing extensions of time for compliance with Directive 2003/32/EC. In summary, the following was agreed.

(i) All applications for complementary certification to have been submitted by manufacturers to their Notified Body by 30 September 2004

(ii) All Summary Evaluation Reports (SERs) requiring consultation to have been submitted by the Notified Body to their home Competent Authority by 31 December 2004.

(iii) All complementary certificates to have been issued by 30 April 2005.

(iv) Manufacturers of affected devices already on the market should withdraw such products unless the following were met:

Complying with Requirements

3. In order to obtain complementary certification or when carrying out conformity assessment in accordance with the new procedures, the manufacturer must submit an application to their Notified Body (NB) for them to undertake a review and produce a Summary Evaluation Report (SER). In accordance with the Annex to the Directive, this should include a consideration of the possible non-TSE susceptible alternatives to the device, and risk minimisation factors such as Geographical BSE Risk (GBR) status and sourcing from closed herds. If the NB is content that the requirements for conformity with Commission Directive 2003/32/EC have been met then, subject to paragraph 4 below, a copy of the SER will be submitted to their Competent Authority.

4. The Directive does not require submission of the SER to the Competent Authority for devices utilising European Directorate for the Quality of Medicines (EDQM) certified material. (Manufacturers of such devices must of course still carry out the risk assessment in article 3 of the Directive and the NB must still evaluate this in accordance with article 5). However, in accordance with European guidance (see paragraph 1 above) the MHRA requests that UK Notified Bodies submit a copy of such SERs.

5. Where devices utilise non-EDQM certified material, it is a requirement of the Directive that Notified Bodies seek (through their won Competent Authority) the opinion of the Competent Authorities of other Member States. Therefore, the NB should submit the SER to their own Competent Authority who then consult with all other Member States. The MHRA and other Competent Authorities will conduct a review of every SER received, covering how TSE risk has been minimised as well as consideration of clinical benefit and the availability and suitability of alternatives. Competent Authorities have twelve weeks from the date on which their opinion was sought to provide any comments to the NB, via the co-ordinating Competent Authority. The Notified Body is obliged to give due consideration to those comments before issuing certification. In addition, according to EU guidance (see paragraph 1 above), the NB should document its final decision and the rationale for any disagreement with the opinion of any Competent Authority. Where there is such disagreement, the guidance states that the NB should consult with their own Competent Authorities. Where the MHRA is consulted, we will aim to provide a response within 20 working days from receipt. The MHRA would not expect a NB to consult the MHRA again before taking a final decision, but NBs are welcome to approach the MHRA if they require further guidance.

6 Below is guidance setting out how the MHRA would expect to handle the different situations which may arise. However, this guidance is general only - the action taken will depend upon the specific circumstances.

Pre-Certification

Products Withdrawn
7. The MHRA requests that UK NBs provide details of manufacturers and products they are aware of as having been withdrawn from the market as a result of the provisions of Directive 2003/32/EC. These details will be passed, with the consent of the manufacturer, to the Royal College of Surgeons, relevant professional bodies and other Competent Authorities.

Timescales not met

8. The MHRA requests that UK Notified Bodies provide details:
(a) of manufacturers and products for which the timescales set out in paragraph 2 above have not been met and
(b) where such timescales have not been met, of manufacturers who have not indicated that the relevant product is being withdrawn. (Other European Union Member States have been requested by the EU Market Surveillance Operations Group (MSOG) to carry out similar exercises with their Notified Bodies).

9. Devices with no Complementary Certificate issued by 30 April 2005 should be withdrawn from the UK market. No device without a Complementary Certificate should be placed on the UK market.

Post-Certification

10. PLEASE NOTE: in the following situations, Complementary certification will have already been issued for the medical device and the device is legally on the market with a CE mark. These notes are intended to represent a general guide only, and the action taken will depend upon the circumstances.

Concerns regarding UK NB SER with EDQM

11. As set out above, although the Directive does not require submission of the SER to the Competent Authority for devices utilising EDQM certified material, the MHRA requests that UK NBs submit a copy of such SERs.

12. When the MHRA received an SER prepared for a product that has received EDQM certification and complementary certification, MHRA will satisfy itself as to the clinical benefits of the material and to verify the risk assessment as to use of alternative material or alternative sources of the material as specified in SER. This is in accordance with European guidance and is part of normal post market surveillance practice. This does not imply that the Complementary Certificate has been issued incorrectly.

13. If MHRA is not satisfied with the analysis above it will consider appropriate action with the manufacturer.

Concerns regarding UK NB issuing Complementary Certification

14. Where there is no EDQM certificate, NBs must seek the opinion of other Competent Authorities (through their own) on their evaluation and conclusions. When the consultation process has been completed for a product without EDQM and the UK NB has issued complementary certification, the MHRA will generally consider the SER again so as to satisfy itself as to the safety and quality of the device as part of its post market surveillance activity. It will also look to see that other Member States comments have been properly addressed.

15. If concerns are raised these will be addressed to the Notified Body and manufacturer.

Concerns regarding a non-UK NB issuing Complementary Certification

16. The majority of SERs that the MHRA reviews originate from other Member States and are for products that do no have EDQM certification. If following the consultation process, complementary certification has been issued but the MHRA still has concerns regarding the clinical benefits or risk minimisation in particular the use of alternative material or the source of the material, and if MHRA consider that their concerns have not been properly addressed, these will be referred to the relevant Competent Authority.

Conclusion

17. In all three scenarios referenced above, if concerns continue, MHRA will consider taking action to remove implicated products from the UK market.