Sweeping new medical device regulations in the European Union are expected to be finalized in December or early 2017, although medical device manufacturers will still have three to five years to comply.
The EU’s new Medical Device Regulation will require risk management and quality management systems, the use of unique device identifiers, major changes to clinical evidence requirements and tighter control over distribution chains. It replaces EU Directives 90/385 (Active Implantable Medical Devices) and 93/42 (Directive Concerning Medical Devices).
Compliance for new devices will be optional when final and mandatory three years later and existing medical devices will have five years to comply, said Paul Brooks, executive director of the Regulatory Affairs Professionals Society.
Substantive changes to the current draft are not expected at this point. It was approved by the European Parliament in May.
But new guidelines published in June 2016—MEDDEV 2.7/1—which are meant to align with provisions in MDR and provide general principles for medical device clinical evaluations and introduce more thorough pre- and postmarket data collection standards, are already causing some frustration.
Ronald Boumans, senior global regulatory consultant at EMERGO’s office in The Hague, said that some manufacturers are complaining that MEDDEV 2.7/1 is being applied as if it had the force of law.
Notified Bodies — organizations designated by an EU country to assess the conformity of certain products before they enter the market — are “already feeling the heat of the designation process required under the MDR, act with almost religious fanaticism” in enforcing the provisions of MEDDEV 2.7/1, he said.
“Suddenly manufacturers of devices that are on the market without serious safety issues may see their certificates suspended or not extended,” Boumans said. That could mean devices that meet current legally binding safety regulations will no longer be available in Europe, he added.
Lincoln Tsang, a partner at Arnold & Porter, said that although guidelines like MEDDEV 2.7/1 have no legal force, the European Court of Justice has consistently held that they are useful for interpreting legal requirements and thus have a “quasi-legal status because a regulatory guidance document represents the agreed view of how the legal requirement can be workably applied in practice.”
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