By Compliance Insight
In this current environment of continuous improvement, the medical device industry has been playing catch-up by tirelessly revising processes and documentation to meet quality standards and keep up with technological advancements. Governments and regulatory agencies are no exception. Just as FDA updates are published annually for the Code of Federal Regulations, international agencies are focused on advancements in scientific understanding and higher quality standards and controls must follow. The European Union (EU) is working to harmonize standards for manufacturers, importers and distributors of medical devices, implantable devices, and in vitro diagnostic medical devices among its member states. The following paragraphs provide an outline of the coming changes.
Expected in late 2016/early 2017, the EU is finalizing their revised Medical Device Regulations (MDR) published in June of this year. Among the many updates are a centralized review system for submissions, improved clinical oversight, and pharmacovigilance and supply chain management, post-marketing assessment and facility inspection activities.
These new regulations, found in EUR-Lex – 52012SC0274 – EN, EUR-Lex – 52012SC0273 – EN, European Commission Part II – Annex I, European Commission Part III – Annex 2 and European Commission Part IV – Appendices, are intended to incorporate, advance and supersede the EU medical device directives implemented in 2007.
These directives incorporated within the MDR include MDD 2007/47/EC and all associated amendments which consolidated the original directives from the EC. For additional details on the current EU regulations, refer to the European Commission website, which also includes a list of all current amendments.
As with most major regulation updates, implementation dates for industry can be tricky. EU regulators have given consideration to the impact of these revisions and have defined the compliance schedule accordingly. Specifically, these regulations have compliance dates as follows:
- Class I medical devices: deadline at the date of application, expected in Q1 of 2020 or before.
- Higher-risk devices: switch to MDR certification once Notified Bodies (NBs, certified oversight entities similar to Institutional Review Boards [IRB]) have been designated for the MDR. Approved Medical Device Directive (MDD) certificates are valid through expiration. Expiration for certificates issued before the MDR date of application should not exceed four years; marketing may continue potentially until Q1 2024.2,3
While the impact on medical device manufacturing and distribution within the member states is direct, the impact on industry in partner countries has yet to be seen. As FDA compliance is required for any medical device industry contributors intending on marketing within the US, the same stands for those intending on marketing and exporting to the EU and compliance is mandatory.
For US manufacturers and exporters, much of what may be required for compliance is evaluation of the regulatory terms used by the MDR and consolidation with those used in FDA regulations, if not performed already. Globally, government regulatory agencies are preparing for these revisions through discussions with the EC and commitments to compliance based on international cooperation initiatives. Per EC dialogues with key trade partner:
“Discussions and exchanges of ideas have been pursued mainly with the US Food and Drug Administration (FDA), Japan Ministry of Health, Labour and Welfare (MHLW), Health/Santé Canada, Australia Therapeutic Goods Administration (TGA), China Food and Drug Administration (SFDA) and China Quality Supervision, Inspection and Quarantine (AQSIQ). The regulatory dialogues on health technology is also active under political umbrellas such as the Transatlantic and Trade Agreement (T-TIP) with the USA, the Free Trade Agreement (FTA) with Japan or the Revised Mutual Recognition Agreement with Australia (Revised MRA).”1
It is clear that the strengthening of the EU regulations is intended to elevate quality by ensuring performance and safety for medical devices marketed within the member states, in turn minimizing unacceptable risks that the use of these devices may pose.
2. Emergo Group White Paper, Understanding Europe’s New Medical Devices Regulation (MDR); Boumans, Ronald and Eisenhart, Stewart; July 2016.
3. UL Compliance to Performance Course (Code: MDR03): CE Certification for Medical Devices, December 2016, www.ComplianceToPerformance.com
For the full article from our Medical Device Communiqué, click here