CHANGED LEGAL REQUIREMENTS
Compliance with the new requirements for medical devices (Directive 2007/47/EC) became mandatory on 21 March 2010.
- Do you have the consolidated version of Directive 93/42/EEC (medical devices) and 90/385/EEC (active implants) that contain the new requirements?
- Did you know that the European Commission considers that many of the “harmonised” technical standards that you may be using may not be in conformity with the new requirements? See what standards are suspect here. This full list of harmonised standards also identifies potentially non-compliant standards. If you use these standards, how do you know that you are in compliance?
- If you have a Class I device or have not yet been certified by your Notified Body against the new requirements, how do you know that you are in compliance?
- Explain the new requirements
- Identify potential non-compliances and suggest solutions
- Help you to implement solutions
NEW CLASSIFICATION AND BORDERLINE CRITERIA
Medical device classification and borderline criteria are changing – are your products in the new gray zones?
- Do you have the latest versions of the Commission’s guidance documents on the drug/device borderline (December 2009) and classification (June 2010)?
- Do you monitor the changes in the Commission’s Manual on Borderlines and Classification (7th version issued in May 2010)?
- Is your documentation on classification and borderline decisions up-to-date?
- Are some of your products now vulnerable to a borderline/classification challenge by the Competent Authorities?
- Review your product portfolio to identify devices vulnerable to changes in borderline and classification status.
- Analyse the possibilities for a range of borderline and classification determinations for a given device.
- Develop a documented rationale for a borderline and classification decision.
- Negotiate with the Notified Body and Competent Authorities to achieve a consensus on a borderline or classification decision.
CHANGING REQUIREMENTS FOR CLINICAL INVESTIGATION AND EVALUATION
The requirements for clinical investigation and evaluation have been subject to a major overhaul in the last two years as a result of changes in the Medical Devices Directive (93/42/EEC) and the Active Implantable Medical Device Directive (90/385/EEC) as well as in guidance and technical standards as evidenced by the following recent documents:
- Clinical Evaluation: A Guide for Manufacturers and Notified Bodies (MEDDEV 2.7.1 Rev. 3; December 2009)
- Guidelines on Clinical investigations: a guide for manufacturers and notified bodies (MEDDEV 2.7/4; December 2010
- Clinical investigations: serious adverse event reporting (MEDDEV 2.7/3; December 2010)
- Clinical investigation of medical devices for human subjects – Part 1 General requirements (EN ISO 14155-1: 2009)
- Clinical investigation of medical devices for human subjects – Part 2 Clinical investigation plans (EN ISO 14155-2: 2009)
High quality clinical evidence to demonstrate compliance with the Essential Requirements has become more important for successful achievement of CE Marking and its maintenance. Although this is true for all devices irrespective of class, its impact on Class I devices is particular significant. Notified Bodies and Competent Authorities are expected to be more alert to weaknesses in compliance in the clinical area than ever before.
- Have you generated clinical evidence dossiers for all your Class I devices?
- Have you updated your operating procedures related to clinical evaluation and investigation taking into account the new requirements?
- Are you planning to initiate a clinical investigation in the near future?
- Prepare product specific clinical evaluation dossiers for file, including for older Class I devices for which little clinical data is available.
- Review your operating procedures and other relevant documentation to ensure that your compliance related to clinical investigation and evaluation is up-to-date.
- Assess any proposed clinical investigations for compliance with the new requirements.
The Commission’s guidance on vigilance (adverse incident reporting) changed significantly in December 2009. This has been complemented by the increased use of electronic reporting systems.
- Have you updated your operating procedures to take into account the guidance from 2009?
- Have you trained relevant personnel to understand and apply the new reporting criteria?
- Are you aware of the new national requirements and opportunities relating to incident reporting?
- Review your vigilance systems to ensure that they meet the new European and national requirements.
- We can propose solutions to fill any gaps and help you to implement them, including training of your staff.
- Assess your post-marketing surveillance system to propose an optimal fit of new vigilance solutions.
Issues to consider in 2011
- Planning for the recast of the medical device regulatory system will continue leading to a concrete proposal in 2012.
- Guidance on the qualification and classification of standalone software is likely to be issued.
- New legislation on electronic labelling is likely to be adopted.
- The role of authorised representatives may become clearer through guidance.
- Work is continuing on integrating the Unique Device Identification (UDI) into European practice.
If we can be of assistance please contact us.