Compliance Centre

Regulatory documentation

Overview EU REP IFU & EUDAMED Material Safety CoC Data Sheet PPWR MDR Labels

Links Medical Products, Inc. maintains full regulatory documentation for the Silent Knight Pill Crushing System, a Class I Medical Device (CE marked). Select a document below.

All documents last reviewed October 2026For details, contact athain@linksmed.com

EU Authorised Representative

Current

Our designated EU REP under MDR Article 11, contactable for any regulatory matter within the European Union.

Last reviewed October 2026

Open document

IFU & EUDAMED

Current

The official multi-language Instructions for Use and live EUDAMED registry records for every device.

Last reviewed October 2026

Open document

Material Safety

Current

Material composition and safety information for the crusher and genuine pouches.

Last reviewed October 2026

Open document

Certificate of Conformity

Current

The EU Declaration of Conformity confirming compliance with Regulation (EU) 2017/745 (MDR).

Last reviewed October 2026

Open document

Packaging declaration (PPWR)

Current

Declaration of conformity for the packaging used to supply the Silent Knight Pill Crusher and pouches (PPWR-001).

Last reviewed October 2026

Open document

Silent Knight Customer Technical Document

Current

Full technical specification of the Silent Knight Pill Crushing System. A PDF copy is available to distributors on request.

Open document

MDR-compliant labels

Coming soon

New labels for the Silent Knight Pill Crusher and pouches, aligned with the labelling requirements of the EU Medical Device Regulation. In preparation.

Open document