Independent conformity assessment, founded in Malta
Malta Conformity Assessment Ltd. is a Notified Body under the Medical Device Regulation (EU) 2017/745, designated by the Malta Medicines Authority.
A partner for the medical device industry
Malta Conformity Assessment Ltd. was founded in Malta to carry out independent conformity assessment activities and is designated as a Notified Body under the Medical Device Regulation (EU) 2017/745.
As a Notified Body we provide conformity assessment services that let manufacturers bring safe and effective medical devices to market. Our team has knowledge and experience in regulatory affairs, clinical evaluation and technical documentation review.
Vision, people and strategy
Three commitments shape how we plan our work and how we treat the manufacturers we assess.
A preferred international body
To be one of the preferred international inspection, surveillance, testing and certification bodies in the areas where we work, with reliable, fast and high-quality services.
Well-trained and improving
Our people are our most valuable asset. We combine their training and commitment with creative and rational thinking to keep improving our services.
Objective and accountable
Objective decision-making and accountability, an organisation built on trust and delegation, and services shaped by our customers’ requirements.
How we keep our work independent
A Notified Body may not design, manufacture, supply or advise on the devices it assesses. These are the safeguards behind that rule, and the documents that set them out.
- PR.04Assessment of Complaints and Appeals ProcedureGeneral
- FR.02Feedback Form: Complaint, Appeal, Suggestion, Information RequestGeneral
- FR.10Confidentiality and Impartiality CommitmentGeneral
- FR.34External Head of Audit Team, Site Auditor, Product Reviewer and Clinical Specialist Service AgreementGeneral
- FR.44Committee Members Confidentiality and Impartiality AgreementGeneral
- FR.250MCA Ethics CodePolicies
- FR.251Malta Conformity Assessment PoliciesPolicies
- FR.252Confidentiality and Impartiality Commitment of Malta Conformity Assessment Ltd.Policies
- FR.306Declaration of Interest: General ManagerPolicies
- FR.306Declaration of Interest: Deputy General ManagerPolicies
- FR.306Declaration of Interest: Medical Devices Department ManagerPolicies
- FR.306Declaration of Interest: Quality Manager / Quality Management RepresentativePolicies
- Signed commitments
Our staff and the external experts we work with sign a confidentiality and impartiality commitment before they take part in an assessment.
FR.10 · FR.34 - Committee members
Members of our committees sign their own confidentiality and impartiality agreement.
FR.44 - Published declarations of interest
Our management declares any interests that could affect impartiality, and we publish those declarations.
FR.306 - Company commitment
Malta Conformity Assessment Ltd. sets out its own confidentiality and impartiality commitment and the policies that support it.
FR.251 · FR.252 - Ethics code
One code of ethics applies to everyone who works for or with us.
FR.250 - Complaints and appeals
Anyone can raise a complaint or appeal a decision, and our procedure explains how we handle it.
PR.04 · FR.02