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12 Dec 2019 - Publication

EBE-EFPIA Position Paper: Approach to Substantial Design Change of the Integral Medical Device Constituent Part Under Article 117: A Risk Based Approach

Since the issuance of the EMA/CMDh “Questions & Answers on Implementation of the Medical Devices and In Vitro Diagnostic Medical Devices Regulations (EU) 2017/745 and (EU) 2017/746), Rev.1”, 2...

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11 Dec 2019 - Position Paper

EBE-EFPIA Reflection Paper: Conformity with the relevant General Safety Performance Requirements listed in the European Medical Device Regulation 2017/745: Case study for a prefilled pen (prefilled syringe assembled with autoinjector parts forming a single integral product regulated as a medicinal product)

Article 117 of the Medical Device Regulation (EU) 2017/745 (MDR) requires the Marketing Authorization Applicant to include a Notified Body Opinion on the device constituent, part of a single integral...

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15 Oct 2019 - Position Paper

EBE Position Paper: "A Risk-Based Approach to Identity Sampling of Biological Drug Substances"

Good Manufacturing Practices require that the identity of materials received for use in the manufacturing of drug products is confirmed. However, the direct sampling of primary containers of biologica...

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Press Releases

14 May 2019

EBE announces the appointment of Michele Antonelli as Vice-President

Brussels, 14 May 2019 – The European Biopharmaceutical Enterprises (EBE) is pleased to announce the appointment of Mr Michele Antonelli, Chief Executive Officer of Stallergenes Greer, as EBE Vice-Pr...

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Position Papers

11 Dec 2019

EBE-EFPIA Reflection Paper: Conformity with the relevant General Safety Performance Requirements listed in the European Medical Device Regulation 2017/745: Case study for a prefilled pen (prefilled syringe assembled with autoinjector parts forming a single integral product regulated as a medicinal product)

Article 117 of the Medical Device Regulation (EU) 2017/745 (MDR) requires the Marketing Authorization Applicant to include a Notified Body Opinion on the device constituent, part of a single integral...

Read more
15 Oct 2019

EBE Position Paper: “A Risk-Based Approach to Identity Sampling of Biological Drug Substances”

Good Manufacturing Practices require that the identity of materials received for use in the manufacturing of drug products is confirmed. However, the direct sampling of primary containers of biologica...

Read more
View All

Publications

12 Dec 2019

EBE-EFPIA Position Paper: Approach to Substantial Design Change of the Integral Medical Device Constituent Part Under Article 117: A Risk Based Approach

Since the issuance of the EMA/CMDh “Questions & Answers on Implementation of the Medical Devices and In Vitro Diagnostic Medical Devices Regulations (EU) 2017/745 and (EU) 2017/746), Rev.1”, 2...

Read more
19 Feb 2019

Exit Strategies for SME Life Science Companies in the EU

When funding life science companies, investors need realistic expectations on how to recover their investment and, potentially, returns on their investment. A number of options exist, commonly c...

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