The Brexit from the EU may be causing a few medical device manufacturers some anxiety over the future of their CE Certificates from British Notified Bodies (e.g., BSI and SGS). The following article discusses this issue briefly:

http://www.raps.org/Regulatory-Focus/News/2016/06/27/25206/MHRA-Mulling-Brexit-Implications-as-UK%E2%80%99s-BSI-Says-it-Will-Remain-an-EU-Notified-Body/

BSI made a statement on Sunday stating that BSI’s role “as an EU Notified Body will not change while UK Government sets out the arrangements for its withdrawal from the EU. We anticipate that products already certified and those certified while the negotiations progress, will continue to be accepted by the EU authorities and member states of the EU.”

The article references Mutual Recognition Agreements as one possible solution for UK Notified Bodies to continue to act as Notified Bodies appointed by an EU member state even though the UK will no longer be an EU member state.

Other options that have been discussed include the UK remaining in the European Economic Area (EEA) or taking on a role similar to Switzerland. These discussions focus more on the options for negotiating an exit by the UK from the EU. However, there are other options specific to the Notified Bodies and certificate validity.

The new European Medical Device Regulations already include options that would address the issue of CE certificate transfer in the follow sections of the regulations:

1. Article 36(1a) refers to the process for notifying national authorities and manufacturers when a Notified Body ceases conformity assessment activities,
2. Article 38 refers to monitoring trends of certificate withdrawls and transfers,
3. Article 46 refers to voluntary changes in Notified Bodies, and

Many Notified Bodies actually consist of more than one Notified Body in multiple countries. For example, BSI purchased a German certification and testing business called Eurocat in 2009 which is now called BSI Group Deutschland GmbH (NB 0535). Another example is SGS. In addition to the NB 0120 in the UK, SGS also has NB 1639 in Belgium and NB 1979 in Hungary. Having Notified Bodies located in multiple countries gives UK Notified Bodies the possibility of transferring certificates within their own corporate structure in order to reduce the impact of the Brexit upon manufacturers that currently have a CE Certificate from a UK Notified Body.

Regardless of what transition is negotiated by the UK and MHRA, manufacturers should carefully consider any transfers to another Notified Body at this time. When the new European Medical Device Regulations are implemented many Notified Bodies may not be designated as Notified Bodies under the new regulation. In this case, a premature transfer from a UK Notified Body to another Notified Body might result in the need to transfer again in just a few years when the new regulations come into effect.

If you are interested in learning more about selection of Notified Bodies and transferring from one Notified Body to another, there will be a webinar on this topic on Thursday, July 14 @ 10am EDT:

http://medicaldeviceacademy.com/notified-body-transfer-webinar/.

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New Clinical Evaluation Report Guidance: MEDDEV 2.7/1 Rev 4 was released!

http://ec.europa.eu/DocsRoom/documents/17522/attachments/1/translations/en/renditions/native

Other recent related EU guidance documents include:

http://ec.europa.eu/DocsRoom/documents/10329/attachments/1/translations/en/renditions/native – Guidelines for Competent Authorities for making a validation/assessment of a clinical investigation application under directives 90/385/EEC and 93/42/EC; September 2015

http://ec.europa.eu/DocsRoom/documents/10330/attachments/1/translations/en/renditions/native – Clinical investigations: serious adverse reporting under directives 90/385/EEC and 93/42/EC; May 2015

source: https://www.linkedin.com/groups/2070960/2070960-6156492647776210948