Essentials of European Medical Device Regulatory Affairs - June 2020

Chapter IX Confidentiality, data protection, funding and penalties

Articles 109-113

• Confidentiality should be respected (commercial and personal) • Member states can charge fees • Penalties can be levied • The member states should inform the commission of those penalties by Feb 2021.

TheOrganisation for Professionals in Regulatory Affairs

Chapter X Final provisions

Articles 114-123

• The commission can be assisted by a committee on medical devices • The Commission create delegating acts to make the regulation work

• Article 120 has the transitional provisions (see introduction )

By May 2027 the Commission has to assess the application of the regulation

Lists other legislation impacted and the fact portions of the legislation can be introduced at different times e.g Pvig and Eudamed.

TheOrganisation for Professionals in Regulatory Affairs

Legislation of Combination Products

Products should be regulated either by the device ormedicines review process. Notboth .

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Devices MDD/MDR

Drugs: 2001/83/EC

Physical

Stent

Sirolimus

Reusable insulin pen

Drug eluting stent

Insulin cartridge

Disposable able insulin pen

123

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